Safety and Efficacy of Bimagrumab and Semaglutide in Adul... | NCT05616013 | Trialant
NCT05616013
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jul 8, 2026Actual
Enrollment
507Actual
Phase
Phase 2
Conditions
Obesity
Obese
Overweight or Obesity
Interventions
Bimagrumab
Semaglutide
Placebo
Countries
United States
Australia
New Zealand
Protocol Section
Identification Module
NCT ID
NCT05616013
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
18828
Secondary IDs
ID
Type
Description
Link
J4Z-MC-GIDA
Other Identifier
Eli Lilly and Company
VER201-PH2-031
Other Identifier
Versanis
Brief Title
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
Official Title
A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 16, 2022Actual
Primary Completion Date
May 16, 2024Actual
Completion Date
Jun 14, 2025Actual
First Submitted Date
Oct 16, 2022
First Submission Date that Met QC Criteria
Nov 9, 2022
First Posted Date
Nov 14, 2022Actual
Results Waived
Not provided
Results First Submitted Date
May 16, 2025
Results First Submitted that Met QC Criteria
Jun 27, 2025
Results First Posted Date
Jul 18, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 11, 2026
Last Update Posted Date
Jul 8, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Versanis Bio, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women
Detailed Description
This study investigates if bimagrumab in addition to semaglutide is able to preserve/increase muscle mass in the presence of weight and/or fat mass loss.
Conditions Module
Conditions
Obesity
Obese
Overweight or Obesity
Keywords
bimagrumab
semaglutide
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
507Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo/30 mg/kg Bimagrumab
Placebo Comparator
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
Other: Placebo
10/30 mg/kg Bimagrumab
Experimental
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
Biological: Bimagrumab
30 mg/kg Bimagrumab
Experimental
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Biological: Bimagrumab
Placebo + 1.0 mg Semaglutide
Experimental
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
Drug: Semaglutide
Other: Placebo
Placebo + 2.4 mg Semaglutide
Experimental
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bimagrumab
Biological
Human monoclonal antibody to the activin receptor type II
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Body Weight at Week 48
Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Waist Circumference at Week 48
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 centimeter (cm). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
A written informed consent must be obtained before any study-related assessments are performed.
Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:
Two negative pregnancy tests (at screening and at randomization, prior to dosing)
Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of bimagrumab/placebo i.v., and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of bimagrumab/placebo i.v.
Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)
Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg
Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration
Key Exclusion Criteria:
History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to semaglutide (Ozempic® or Wegovy®)
Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations
Treatment with any medication for the indication of obesity within the past 30 days before screening
Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion.
Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection.
Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (> 250 mL) within 14 days prior to the first dose
Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
FG001
10/30 mg/kg Bimagrumab
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 9, 2024
Jun 23, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Brazil
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
The study is designed to have three periods. The 48-week core treatment period has 9 treatment arms, with combinations of 3 semaglutide doses (none, 1.0 mg and 2.4 mg) and 3 bimagrumab doses (0, 10 and 30 mg/kg). The core treatment period is then followed by an open-label 24-week treatment extension period during which participants originally assigned to either placebo or bimagrumab 10 mg/kg will switch to bimagrumab 30 mg/kg. All other treatment assignments will remain the same. The extension period is then followed by a 32-week post-treatment period, during which all study treatments will be withdrawn from all arms.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
In regard to bimagrumab and placebo-bimagrumab, the participants, Investigator and Sponsor will be blinded.
Due to semaglutide being pre-filled, packaged and labeled by manufacturer, it is not possible to blind semaglutide.
Who Masked
ParticipantInvestigator
Drug: Semaglutide
Other: Placebo
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Experimental
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
Biological: Bimagrumab
Drug: Semaglutide
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Experimental
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Biological: Bimagrumab
Drug: Semaglutide
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Experimental
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
Biological: Bimagrumab
Drug: Semaglutide
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Experimental
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Biological: Bimagrumab
Drug: Semaglutide
10/30 mg/kg Bimagrumab
30 mg/kg Bimagrumab
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Semaglutide
Drug
Glucagon-like peptide-1 (GLP-1) receptor agonist
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Placebo + 1.0 mg Semaglutide
Placebo + 2.4 mg Semaglutide
Wegovy
Ozempic
Placebo
Other
Placebo
Placebo + 1.0 mg Semaglutide
Placebo + 2.4 mg Semaglutide
Placebo/30 mg/kg Bimagrumab
Baseline, Week 48
Change From Baseline in Waist Circumference at Week 72
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48
Change from baseline in total body fat mass in kg was assessed by Dual energy X-ray absorptiometry (DXA). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in Total Body Fat Mass in kg at Week 72
Change from baseline in total body fat mass in kg was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percent Change From Baseline for Fat Mass by DXA at Week 48
Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Percent Change From Baseline for Fat Mass by DXA at Week 72
Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48
Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72
Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 5 cm at Week 48
Waist circumference was measured in a standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48
Body weight was measured in kgs to the nearest 0.1 kg. Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48
Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants Achieving Fat Mass ≥ 10% Reduction With <5% Decrease in Lean Mass by DXA at Week 48
Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48
Fat Lost Index = % change in fat mass/% change in lean mass + % change in fat mass. Only participants with non-missing baseline value were included in analysis.
Week 48
Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48
Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Change From Baseline in Body Fat Mass by BIA at Week 72
Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Percent Change From Baseline in Body Fat by BIA at Week 48
Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Percent Change From Baseline in Body Fat by BIA at Week 72
Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Change From Baseline in Lean Mass by DXA at Week 48
Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in Lean Mass by DXA at Week 72
Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percent Change From Baseline in Lean Body Mass by DXA at Week 48
Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Percent Change From Baseline in Lean Body Mass by DXA at Week 72
Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 48
Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 72
Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Change From Baseline in Lean Mass (kg) by BIA at Week 48
Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Change From Baseline in Lean Mass (kg) by BIA at Week 72
Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Percent Change From Baseline in Lean Body Mass by BIA at Week 48
Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Percent Change From Baseline in Lean Body Mass by BIA at Week 72
Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48
BMI categories:
i. Healthy weight: 18.5 kilograms (kg)/meter (m)² to 24.9 kg/m² ii. Overweight: 25 kg/m² to 29.9 kg/m² iii. Obesity class 1: 30 kg/m² to 34.9 kg/m² iv. Obesity class II: 35 kg/m² to 39.9 kg/m² v. Obesity class III: ≥ 40 kg/m2
Baseline, Week 48
Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48
WHtR ratio categories: <0.5; 0.5-0.59; ≥0.6
Baseline up to 48 weeks
Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48
WHtR ratio categories: <0.5; 0.5-0.59; ≥0.6
Baseline up to 48 weeks
Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48
WHtR ratio categories: <0.5; 0.5-0.59; ≥0.6
Baseline up to 48 weeks
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48
HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, 48 weeks
Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24
The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.
Baseline, Week 24
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into (mental component score [MCS] and physical component score [PCS] to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
Baseline, Week 24
Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48
The SF-36v2 acute form assesses HRQoL on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10 items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores
Baseline, Week 48
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into MCS and PCS to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
Baseline, Week 48
Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 72
The SF-36v2 acute form assesses HRQoL on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10 items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores
Baseline, Week 72
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 72
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into MCS and PCS to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
Baseline, Week 72
Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.'
Baseline, Week 24
Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.'
Baseline, Week 48
Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 72
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.'
Baseline, Week 72
Cullman
Alabama
35055
United States
Indago Research & Health Center, Inc
Hialeah
Florida
33012
United States
Clinical Neuroscience Solutions Inc
Jacksonville
Florida
32256
United States
Altus Research
Lake Worth
Florida
33461
United States
Pennington Biomedical Research Center
Baton Rouge
Louisiana
70808
United States
Weill Cornell Medical College
New York
New York
10021
United States
Monroe Biomedical Research
Monroe
North Carolina
28112
United States
SPICA Clinical
Columbia
South Carolina
29322
United States
Mt. Olympus Medical Research
Sugar Land
Texas
77479
United States
Northern Beaches Clinical Research
Brookvale
New South Wales
2100
Australia
Royal North Shore Hospital
Saint Leonards
New South Wales
2065
Australia
University of The Sunshine Coast Morayfield
Morayfield
Queensland
4506
Australia
University of the Sunshine Coast Clinical Trial Centre
Sippy Downs
Queensland
04556
Australia
University of The Sunshine Coast South Brisbane
South Brisbane
Queensland
4101
Australia
Gold Coast University Hospital
Southport
Queensland
4215
Australia
Austin Health
Heidelberg Heights
Victoria
3081
Australia
Emeritus Research
Camberwell
3124
Australia
Southern Clinical Trials Ltd
Beckenham, Christchurch
Canterbury
8013
New Zealand
P3 Research
Newtown
Wellington Region
6242
New Zealand
New Zealand Clinical Research Auckland
Auckland
1010
New Zealand
Optimal Clinical Trials
Auckland
1010
New Zealand
Middlemore Hospital
Auckland
2025
New Zealand
New Zealand Clinical Research Christchurch
Christchurch
8011
New Zealand
Lakeland Clinical Trials Waikato
Hamilton
3200
New Zealand
Southern Clinical Trials Tasman
Nelson
7011
New Zealand
Derived
Moon S, Choi JW, Park JH, Kim DS, Ahn Y, Kim Y, Kong SH, Oh CM. Association of Appendicular Skeletal Muscle Mass Index and Insulin Resistance With Mortality in Multi-Nationwide Cohorts. J Cachexia Sarcopenia Muscle. 2025 Apr;16(2):e13811. doi: 10.1002/jcsm.13811.
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
FG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
FG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
FG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
FG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
FG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
FG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
FG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
FG00056 subjects
FG00156 subjects
FG00257 subjects
FG00356 subjects
FG00457 subjects
FG00556 subjects
FG00656 subjects
FG00756 subjects
FG00857 subjects
Safety Analysis Population (Received at Least 1 Dose of Study Drug)
FG00055 subjects
FG00156 subjects
FG00257 subjects
FG00355 subjects
FG00456 subjects
FG00556 subjects
FG00655 subjects
FG00756 subjects
FG00855 subjects
COMPLETED
"Completer" includes participants who completed all protocol-scheduled visits until Week 104.
FG00022 subjects
FG00125 subjects
FG00227 subjects
FG00333 subjects
FG00439 subjects
FG00528 subjects
FG00635 subjects
FG00737 subjects
FG00835 subjects
NOT COMPLETED
FG00034 subjects
FG00131 subjects
FG00230 subjects
FG00323 subjects
FG00418 subjects
FG00528 subjects
FG00621 subjects
FG00719 subjects
FG00822 subjects
Type
Comment
Reasons
Adverse Event
FG0008 subjects
FG00112 subjects
FG0029 subjects
FG0034 subjects
FG0046 subjects
FG0058 subjects
FG0063 subjects
FG0076 subjects
FG0081 subjects
Lost to Follow-up
FG0007 subjects
FG0014 subjects
FG0026 subjects
FG0034 subjects
FG004
Non-compliance with study requirements
FG0003 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG00013 subjects
FG00110 subjects
FG0028 subjects
FG00310 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Other
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
BG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
BG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
BG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
BG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
BG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
BG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
BG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
BG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00056
BG00156
BG00257
BG00356
BG00457
BG00556
BG00656
BG00756
BG00857
BG009507
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.8± 14.6
BG00144.4± 10.9
BG00249.2± 12.2
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00032
BG00132
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG00111
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Australia
Title
Measurements
BG00012
BG0018
BG002
Body Weight
Mean
Standard Deviation
kilogram (kg)
Title
Denominators
Categories
Title
Measurements
BG000109.55± 19.33
BG001105.12± 19.50
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Body Weight at Week 48
Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
kilogram (kg)
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00035
OG00131
OG00237
OG003
Title
Denominators
Categories
Title
Measurements
OG000-3.31± 1.39
OG001-5.99± 1.42
OG002-9.25± 1.33
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Bima 30mg/kg + Sema 2.4mg vs Placebo
ANCOVA
<0.001
LS Mean Change difference
-14.5
2-Sided
95
-18.0
-11.0
Superiority
OG000
OG007
Bima 30mg/kg + Sema 1.0mg vs Placebo
ANCOVA
Secondary
Change From Baseline in Waist Circumference at Week 48
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 centimeter (cm). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
centimeter (cm)
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
Secondary
Change From Baseline in Waist Circumference at Week 72
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
centimeter (cm)
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
Secondary
Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48
Change from baseline in total body fat mass in kg was assessed by Dual energy X-ray absorptiometry (DXA). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Kilogram (kg)
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
Secondary
Change From Baseline in Total Body Fat Mass in kg at Week 72
Change from baseline in total body fat mass in kg was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Kilogram (kg)
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Percent Change From Baseline for Fat Mass by DXA at Week 48
Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Percent Change From Baseline for Fat Mass by DXA at Week 72
Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48
Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome. Number analysed are the participants evaluable for specified categories.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
Secondary
Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72
Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome. Number analysed are the participants evaluable for specified categories.
Posted
Least Squares Mean
Standard Error
Kilogram (kg)
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
Secondary
Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 5 cm at Week 48
Waist circumference was measured in a standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Only participants with non-missing baseline value were included in analysis.
All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Secondary
Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48
Body weight was measured in kgs to the nearest 0.1 kg. Only participants with non-missing baseline value were included in analysis.
All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Secondary
Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48
Only participants with non-missing baseline value were included in analysis.
All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Secondary
Percentage of Participants Achieving Fat Mass ≥ 10% Reduction With <5% Decrease in Lean Mass by DXA at Week 48
Only participants with non-missing baseline value were included in analysis.
All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Secondary
Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48
Fat Lost Index = % change in fat mass/% change in lean mass + % change in fat mass. Only participants with non-missing baseline value were included in analysis.
All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Secondary
Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48
Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Change From Baseline in Body Fat Mass by BIA at Week 72
Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Percent Change From Baseline in Body Fat by BIA at Week 48
Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Percent Change From Baseline in Body Fat by BIA at Week 72
Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Change From Baseline in Lean Mass by DXA at Week 48
Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Change From Baseline in Lean Mass by DXA at Week 72
Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Percent Change From Baseline in Lean Body Mass by DXA at Week 48
Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Percent Change From Baseline in Lean Body Mass by DXA at Week 72
Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 48
Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 72
Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Change From Baseline in Lean Mass (kg) by BIA at Week 48
Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Change From Baseline in Lean Mass (kg) by BIA at Week 72
Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Percent Change From Baseline in Lean Body Mass by BIA at Week 48
Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Percent Change From Baseline in Lean Body Mass by BIA at Week 72
Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48
BMI categories:
i. Healthy weight: 18.5 kilograms (kg)/meter (m)² to 24.9 kg/m² ii. Overweight: 25 kg/m² to 29.9 kg/m² iii. Obesity class 1: 30 kg/m² to 34.9 kg/m² iv. Obesity class II: 35 kg/m² to 39.9 kg/m² v. Obesity class III: ≥ 40 kg/m2
All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome at the specified timepoint.
Posted
Number
percentage of participants
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48
WHtR ratio categories: <0.5; 0.5-0.59; ≥0.6
All randomized participants who received at least one dose of the study drug and had a baseline WtHR category <0.5 and had evaluable data at week 48.
As no enrolled participants had a baseline waist-to-height ratio (WtHR) below 0.5, this outcome measure was not analyzed, and no participants were included in the analysis.
Posted
Baseline up to 48 weeks
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48
WHtR ratio categories: <0.5; 0.5-0.59; ≥0.6
All randomized participants who received at least one dose of the study drug and had Baseline WtHR Category 0.5-0.59 and had evaluable data at week 48.
No participants were included in the analysis for the "30 mg/kg Bimagrumab","10 mg/kg Bimagrumab + 2.4 mg semaglutide ," and "30 mg/kg Bimagrumab + 1.0 mg semaglutide " reporting arms, as none of the enrolled individuals in these groups had a baseline WtHR of 0.5-0.59.
Posted
Number
percentage of participants
Baseline up to 48 weeks
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Secondary
Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48
WHtR ratio categories: <0.5; 0.5-0.59; ≥0.6
All randomized participants who received at least one dose of the study drug and had Baseline WtHR Category ≥0.6 and had evaluable data at week 48
Posted
Number
percentage of participants
Baseline up to 48 weeks
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Secondary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48
HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
percentage of HbA1c
Baseline, 48 weeks
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
Secondary
Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24
The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
t-score
Baseline, Week 24
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
Secondary
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into (mental component score [MCS] and physical component score [PCS] to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48
The SF-36v2 acute form assesses HRQoL on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10 items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
t-score
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into MCS and PCS to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 72
The SF-36v2 acute form assesses HRQoL on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10 items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
t-score
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 72
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into MCS and PCS to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
OG002
30 mg/kg Bimagrumab
Secondary
Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.'
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
Secondary
Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.'
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 48
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
Secondary
Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 72
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.'
All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 72
ID
Title
Description
OG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
OG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
Time Frame
Baseline up to Week 104
Description
All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
0
55
5
55
46
55
EG001
10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
0
56
9
56
54
56
EG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
0
57
8
57
54
57
EG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
0
55
4
55
52
55
EG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
0
56
8
56
52
56
EG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
0
56
7
56
53
56
EG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
0
55
8
55
54
55
EG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
0
56
6
56
54
56
EG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
0
55
7
55
54
55
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Visual impairment
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG0030 events0 affected55 at risk
EG0040 events0 affected56 at risk
EG0051 events1 affected56 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected56 at risk
EG0080 events0 affected55 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Mallory-weiss syndrome
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Mesenteric artery aneurysm
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Chest pain
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gallbladder disorder
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gallbladder enlargement
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Anal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Arthritis viral
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Giardiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Haematoma infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Otitis externa
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Perineal cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pilonidal disease
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Post-acute covid-19 syndrome
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Urosepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Viral rash
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Compartment syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vertebral foraminal stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Ovarian adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG0031 events1 affected55 at risk
EG0041 events1 affected56 at risk
EG0051 events1 affected56 at risk
EG0060 events0 affected55 at risk
EG0072 events2 affected56 at risk
EG0081 events1 affected55 at risk
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0012 events2 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Aortic valve disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Palpitations
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hyperacusis
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Goitre
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Oestrogen deficiency
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blepharospasm
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cataract
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Extraocular muscle disorder
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Eye swelling
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Eyelid disorder
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Periorbital dermatitis
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Periorbital swelling
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Photopsia
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Retinal tear
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Swelling of eyelid
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vision blurred
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Visual impairment
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0004 events4 affected55 at risk
EG0012 events2 affected56 at risk
EG0024 events4 affected57 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0013 events3 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Bowel movement irregularity
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Change of bowel habit
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 events3 affected55 at risk
EG0012 events2 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Dental discomfort
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Dental pulp disorder
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00010 events10 affected55 at risk
EG00127 events27 affected56 at risk
EG00229 events29 affected57 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infrequent bowel movements
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Intestinal metaplasia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0009 events9 affected55 at risk
EG00115 events15 affected56 at risk
EG0028 events8 affected57 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Palatal polyp
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Spigelian hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tongue spasm
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0015 events5 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Administration site swelling
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Catheter site pain
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Chest discomfort
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Chest pain
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Chills
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Complication associated with device
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cyst
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Discomfort
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Early satiety
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Exercise tolerance decreased
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0003 events3 affected55 at risk
EG0014 events4 affected56 at risk
EG0024 events4 affected57 at risk
EG003
Feeling abnormal
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Feeling cold
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Feeling hot
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hernia
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hunger
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Impaired healing
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Influenza like illness
General disorders
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0013 events3 affected56 at risk
EG0024 events4 affected57 at risk
EG003
Infusion site bruising
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infusion site extravasation
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infusion site rash
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infusion site reaction
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infusion site swelling
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Injection site bruising
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Injection site pain
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Injection site reaction
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Malaise
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Oedema
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Pain
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Peripheral swelling
General disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Swelling
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Swelling face
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Temperature intolerance
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Therapeutic response unexpected
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Thirst
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vaccination site reaction
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Hepatic atrophy
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Food allergy
Immune system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Immunisation reaction
Immune system disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Acne pustular
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Anal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Beta haemolytic streptococcal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Body tinea
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Breast cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Candida infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Covid-19
Infections and infestations
MedDRA
Systematic Assessment
EG00011 events11 affected55 at risk
EG00117 events17 affected56 at risk
EG00216 events16 affected57 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Ear infection bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Ear infection fungal
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
External ear cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Eye infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Folliculitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Fungal foot infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gastritis bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0004 events4 affected55 at risk
EG0016 events6 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Systematic Assessment
EG0003 events3 affected55 at risk
EG0013 events3 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gingival abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Gingivitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gonorrhoea
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Hordeolum
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infected bite
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infected cyst
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infective exacerbation of bronchiectasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0014 events4 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Kidney infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Localised infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0012 events2 affected56 at risk
EG0026 events6 affected57 at risk
EG003
Mastitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0005 events5 affected55 at risk
EG0017 events7 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Omphalitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Oral herpes
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Otitis externa
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Paronychia
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Penile infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Post viral fatigue syndrome
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Post-acute covid-19 syndrome
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pustule
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Rash pustular
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0011 events1 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Skin candida
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Skin infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Tinea infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Tonsillitis streptococcal
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Tooth infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG00011 events11 affected55 at risk
EG00113 events13 affected56 at risk
EG00213 events13 affected57 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Vaginal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Vestibular neuronitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0015 events5 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Wound infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Burn oral cavity
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0013 events3 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Foreign body in skin or subcutaneous tissue
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gingival injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0005 events5 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Limb crushing injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Neck injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Periorbital haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Post procedural contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Procedural dizziness
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Procedural headache
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Synovial rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0012 events2 affected56 at risk
EG0024 events4 affected57 at risk
EG003
Amylase increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA
Systematic Assessment
EG0007 events7 affected55 at risk
EG0019 events9 affected56 at risk
EG0028 events8 affected57 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood folate decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Blood glucose increased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Blood iron decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood potassium decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood pressure decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood pressure increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Blood uric acid increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Bone density decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cardiac murmur
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Electrocardiogram t wave inversion
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Eosinophil count increased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Heart rate decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Heart rate increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Heart rate irregular
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Hepatic enzyme abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Human metapneumovirus test positive
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Lipase increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Lipids increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Liver function test abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Liver function test increased
Investigations
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Nitrite urine present
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Platelet count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Red blood cell sedimentation rate increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Red blood cells urine positive
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Transaminases increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Troponin increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Urine albumin/creatinine ratio increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Urine analysis abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Urine bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vitamin b12 decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vitamin d decreased
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
White blood cells urine positive
Investigations
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Abnormal weight gain
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Appetite disorder
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0004 events4 affected55 at risk
EG0014 events4 affected56 at risk
EG0026 events6 affected57 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Food intolerance
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0024 events4 affected57 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0012 events2 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0006 events6 affected55 at risk
EG0011 events1 affected56 at risk
EG0028 events8 affected57 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Axillary mass
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0004 events4 affected55 at risk
EG0013 events3 affected56 at risk
EG0024 events4 affected57 at risk
EG003
Bone cyst
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Compartment syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Dupuytren's contracture
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Exostosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Inguinal mass
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Joint instability
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Medial tibial stress syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Muscle fatigue
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00022 events22 affected55 at risk
EG00127 events27 affected56 at risk
EG00241 events41 affected57 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0004 events4 affected55 at risk
EG0012 events2 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0012 events2 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 events2 affected55 at risk
EG0016 events6 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0023 events3 affected57 at risk
EG003
Osteochondritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0004 events4 affected55 at risk
EG0013 events3 affected56 at risk
EG0024 events4 affected57 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0022 events2 affected57 at risk
EG003
Patellofemoral pain syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Sacral pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Sarcopenia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Tendon discomfort
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected57 at risk
EG003
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Benign neoplasm of thyroid gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Colorectal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Haemangioma of liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 events1 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Intraductal papilloma of breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 events0 affected55 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected57 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00035
OG00131
OG00237
OG00345
OG00451
OG00541
OG00639
OG00743
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-4.71± 1.27
OG001-7.88± 1.28
OG002-10.64± 1.16
OG003-10.57± 1.22
OG004-13.60± 1.11
OG005-14.63± 0.90
OG006-16.55± 1.00
OG007-15.84± 1.10
OG008-19.03± 1.09
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00026
OG00126
OG00231
OG00340
OG00445
OG00534
OG00639
OG00742
OG00839
Title
Denominators
Categories
Title
Measurements
OG000-7.89± 1.32
OG001-9.59± 1.51
OG002-13.04± 1.30
OG003-10.40± 1.41
OG004-14.67± 1.33
OG005-15.59± 1.07
OG006-18.10± 1.24
OG007-18.21± 1.30
OG008-21.26± 1.26
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00030
OG00130
OG00236
OG00345
OG00447
OG00542
OG00640
OG00742
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-2.41± 0.76
OG001-6.90± 0.88
OG002-11.86± 1.03
OG003-7.49± 0.96
OG004-11.06± 0.86
OG005-14.17± 0.84
OG006-15.93± 0.85
OG007-15.33± 0.94
OG008-19.30± 0.82
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00019
OG00123
OG00227
OG00338
OG00443
OG00532
OG00638
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG000-7.33± 0.87
OG001-7.84± 1.17
OG002-13.24± 1.19
OG003-7.66± 1.08
OG004-12.47± 1.07
OG005-15.85± 1.10
OG006-17.52± 1.13
OG007-16.72± 1.19
OG008-21.24± 1.13
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00030
OG00130
OG00236
OG00345
OG00447
OG00542
OG00640
OG00742
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-5.53± 1.59
OG001-15.65± 1.97
OG002-25.23± 2.20
OG003-18.36± 2.28
OG004-24.57± 1.57
OG005-30.60± 1.70
OG006-35.85± 1.91
OG007-34.42± 2.02
OG008-42.06± 1.81
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00019
OG00123
OG00227
OG00338
OG00443
OG00532
OG00638
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG000-16.60± 2.11
OG001-18.45± 2.65
OG002-28.35± 2.45
OG003-18.97± 2.55
OG004-27.37± 2.11
OG005-33.58± 2.12
OG006-39.46± 2.46
OG007-37.26± 2.48
OG008-45.42± 2.12
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00030
OG00130
OG00236
OG00345
OG00447
OG00542
OG00640
OG00742
OG00843
Title
Denominators
Categories
VAT
ParticipantsOG00029
ParticipantsOG00130
ParticipantsOG00232
ParticipantsOG00344
ParticipantsOG00445
ParticipantsOG00541
ParticipantsOG00640
ParticipantsOG00741
ParticipantsOG00841
Title
Measurements
OG000-0.05± 0.06
OG001-0.36± 0.04
OG002-0.61± 0.06
OG003
SAT
ParticipantsOG00029
ParticipantsOG00130
ParticipantsOG00234
ParticipantsOG00344
Trunk fat mass
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG00236
ParticipantsOG00345
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00019
OG00123
OG00227
OG00338
OG00443
OG00532
OG00638
OG00741
OG00834
Title
Denominators
Categories
VAT
ParticipantsOG00018
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00337
ParticipantsOG00442
ParticipantsOG00531
ParticipantsOG00637
ParticipantsOG00740
ParticipantsOG00832
Title
Measurements
OG000-0.27± 0.07
OG001-0.39± 0.06
OG002-0.65± 0.06
OG003
SAT
ParticipantsOG00018
ParticipantsOG00123
ParticipantsOG00226
ParticipantsOG00337
Trunk Fat Mass
ParticipantsOG00019
ParticipantsOG00123
ParticipantsOG00227
ParticipantsOG00338
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00035
OG00131
OG00237
OG00345
OG00451
OG00541
OG00639
OG00743
OG00843
Title
Denominators
Categories
Title
Measurements
OG00045.7
OG00171.0
OG00278.4
OG00366.7
OG00482.4
OG00595.1
OG006100.0
OG00790.7
OG00897.7
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00035
OG00131
OG00237
OG00345
OG00451
OG00541
OG00640
OG00743
OG00843
Title
Denominators
Categories
Reduction in ≥ 5%
Title
Measurements
OG00040.0
OG00158.1
OG00283.8
OG00373.3
OG00492.2
OG00597.6
OG006100.0
OG00797.7
OG00897.7
Reduction in ≥ 10% Body Weight
Title
Measurements
OG0008.6
OG00129.0
OG00251.4
OG003
Reduction in ≥ 15% Body Weight
Title
Measurements
OG0005.7
OG00116.1
OG00232.4
OG003
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00030
OG00130
OG00236
OG00345
OG00447
OG00542
OG00640
OG00742
OG00843
Title
Denominators
Categories
≥ 5% reduction in Fat Mass
Title
Measurements
OG00043.3
OG00193.3
OG00297.2
OG00380.0
OG00497.9
OG005100.0
OG006100.0
OG007100.0
OG008100.0
≥ 10% reduction in Fat Mass
Title
Measurements
OG00023.3
OG00190.0
OG00288.9
OG003
≥ 15% reduction in Fat Mass
Title
Measurements
OG00010.0
OG00153.3
OG00275.0
OG003
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00030
OG00130
OG00236
OG00345
OG00447
OG00542
OG00640
OG00742
OG00843
Title
Denominators
Categories
Title
Measurements
OG00016.7
OG00183.3
OG00277.8
OG00326.7
OG00419.1
OG00561.9
OG00665.0
OG00776.2
OG00867.4
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00055
OG00156
OG00257
OG00355
OG00456
OG00556
OG00655
OG00756
OG00855
Title
Denominators
Categories
>5kg Weight Loss and Fat Loss Index >70 %
Title
Measurements
OG00014.55
OG00126.79
OG00240.35
OG00341.82
OG00450.00
OG00562.50
OG00665.45
OG00764.29
OG00872.73
>5kg Weight Loss and Fat Loss Index >80 %
Title
Measurements
OG00012.73
OG00123.21
OG00236.84
OG003
>5kg Weight Loss and Fat Loss Index >90 %
Title
Measurements
OG0003.64
OG00119.64
OG00235.09
OG003
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00035
OG00131
OG00237
OG00345
OG00451
OG00541
OG00640
OG00743
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-2.72± 0.77
OG001-6.45± 0.78
OG002-9.84± 0.81
OG003-7.54± 0.93
OG004-10.83± 0.75
OG005-12.85± 0.69
OG006-14.71± 0.87
OG007-14.16± 0.82
OG008-16.87± 0.72
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00026
OG00126
OG00231
OG00340
OG00444
OG00534
OG00639
OG00742
OG00839
Title
Denominators
Categories
Title
Measurements
OG000-5.69± 0.87
OG001-7.20± 0.97
OG002-10.24± 1.00
OG003-6.49± 1.12
OG004-11.56± 0.95
OG005-13.94± 0.97
OG006-14.86± 0.92
OG007-14.95± 0.97
OG008-19.43± 0.97
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00035
OG00131
OG00237
OG00345
OG00451
OG00541
OG00640
OG00743
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-1.49± 0.38
OG001-3.82± 0.45
OG002-5.70± 0.46
OG003-3.80± 0.65
OG004-5.18± 0.43
OG005-7.03± 0.42
OG006-8.47± 0.68
OG007-8.39± 0.61
OG008-9.33± 0.50
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00026
OG00126
OG00231
OG00340
OG00444
OG00534
OG00639
OG00742
OG00839
Title
Denominators
Categories
Title
Measurements
OG000-3.63± 0.45
OG001-4.36± 0.54
OG002-5.65± 0.57
OG003-3.06± 0.75
OG004-5.46± 0.56
OG005-7.43± 0.62
OG006-8.29± 0.66
OG007-8.71± 0.63
OG008-11.33± 0.84
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00030
OG00130
OG00236
OG00345
OG00447
OG00542
OG00640
OG00742
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-0.33± 0.53
OG0011.48± 0.51
OG0021.19± 0.55
OG003-2.86± 0.45
OG004-4.43± 0.35
OG005-1.28± 0.42
OG006-1.12± 0.54
OG007-0.65± 0.66
OG008-1.43± 0.50
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 71: 1.0 mg.
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00019
OG00123
OG00227
OG00338
OG00443
OG00532
OG00638
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG0001.89± 0.72
OG0012.26± 0.56
OG0021.28± 0.58
OG003-2.78± 0.48
OG004-4.05± 0.45
OG005-1.04± 0.54
OG006-1.78± 0.52
OG007-0.79± 0.70
OG008-1.84± 0.57
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00030
OG00130
OG00236
OG00345
OG00447
OG00542
OG00640
OG00742
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-0.54± 0.79
OG0012.81± 0.84
OG0022.39± 0.93
OG003-5.23± 0.79
OG004-7.90± 0.60
OG005-2.21± 0.78
OG006-1.92± 0.85
OG007-1.00± 1.01
OG008-2.51± 0.87
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00019
OG00123
OG00227
OG00338
OG00443
OG00532
OG00638
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG0003.51± 1.14
OG0014.17± 0.96
OG0022.71± 0.96
OG003-5.09± 0.86
OG004-7.23± 0.79
OG005-1.96± 0.96
OG006-2.89± 0.81
OG007-1.38± 1.11
OG008-3.00± 1.00
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00030
OG00130
OG00236
OG00345
OG00447
OG00542
OG00640
OG00742
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-0.87± 0.82
OG0013.07± 1.14
OG0022.47± 0.96
OG003-5.68± 0.89
OG004-9.43± 0.77
OG005-2.31± 0.79
OG006-2.22± 0.91
OG007-1.74± 1.00
OG008-2.28± 0.99
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00019
OG00123
OG00227
OG00338
OG00443
OG00532
OG00638
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG0004.76± 1.47
OG0014.98± 1.16
OG0022.78± 1.15
OG003-6.24± 1.09
OG004-9.08± 0.87
OG005-2.30± 1.13
OG006-3.87± 0.86
OG007-2.29± 1.13
OG008-2.40± 1.29
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00035
OG00131
OG00237
OG00345
OG00451
OG00541
OG00640
OG00743
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-0.57± 0.38
OG001-0.13± 0.55
OG002-1.68± 0.46
OG003-3.40± 0.69
OG004-4.40± 0.44
OG005-2.73± 0.37
OG006-3.15± 0.52
OG007-2.73± 0.55
OG008-4.62± 0.48
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00026
OG00126
OG00231
OG00340
OG00444
OG00534
OG00639
OG00742
OG00839
Title
Denominators
Categories
Title
Measurements
OG0000.30± 0.49
OG001-0.54± 0.56
OG002-2.45± 0.62
OG003-4.34± 0.64
OG004-5.01± 0.45
OG005-3.32± 0.48
OG006-5.79± 1.11
OG007-3.95± 0.57
OG008-4.50± 0.82
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00035
OG00131
OG00237
OG00345
OG00451
OG00541
OG00640
OG00743
OG00843
Title
Denominators
Categories
Title
Measurements
OG0001.71± 0.52
OG0013.62± 0.47
OG0025.35± 0.47
OG0034.02± 0.67
OG0045.09± 0.40
OG0056.83± 0.45
OG0068.29± 0.69
OG0077.23± 0.92
OG0088.91± 0.50
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00026
OG00126
OG00231
OG00340
OG00444
OG00534
OG00639
OG00742
OG00839
Title
Denominators
Categories
Title
Measurements
OG0002.29± 1.55
OG0014.05± 0.57
OG0024.65± 0.68
OG0032.80± 1.17
OG0044.66± 0.89
OG0056.52± 1.41
OG0066.89± 1.37
OG0076.79± 1.34
OG00810.64± 0.84
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00055
OG00156
OG00257
OG00355
OG00456
OG00556
OG00655
OG00756
OG00855
Title
Denominators
Categories
Healthy weight (Baseline)
ParticipantsOG00055
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
ParticipantsOG00456
ParticipantsOG00556
ParticipantsOG00655
ParticipantsOG00756
ParticipantsOG00855
Title
Measurements
OG0000
OG0010
OG0020
OG003
Overweight (Baseline)
ParticipantsOG00055
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Obesity class I (Baseline)
ParticipantsOG00055
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Obesity class II (Baseline)
ParticipantsOG00055
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Obesity class III (Baseline)
ParticipantsOG00055
ParticipantsOG00156
ParticipantsOG00257
ParticipantsOG00355
Healthy weight (Week 48)
ParticipantsOG00035
ParticipantsOG00131
ParticipantsOG00237
ParticipantsOG00345
Overweight (Week 48)
ParticipantsOG00035
ParticipantsOG00131
ParticipantsOG00237
ParticipantsOG00345
Obesity class I (Week 48)
ParticipantsOG00035
ParticipantsOG00131
ParticipantsOG00237
ParticipantsOG00345
Obesity class II (Week 48)
ParticipantsOG00035
ParticipantsOG00131
ParticipantsOG00237
ParticipantsOG00345
Obesity class III (Week 48)
ParticipantsOG00035
ParticipantsOG00131
ParticipantsOG00237
ParticipantsOG00345
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Title
Denominators
Categories
WtHR Category: <0.5
WtHR Category: 0.5-0.59
WtHR Category: ≥0.6
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG0005
OG0013
OG0020
OG0036
OG0043
OG0052
OG0060
OG0070
OG0084
Title
Denominators
Categories
WtHR Category: <0.5
Title
Measurements
OG0000
OG0010
OG00350.0
OG0040
OG0050
OG00825.0
WtHR Category: 0.5-0.59
Title
Measurements
OG00060.0
OG001100.0
OG00350.0
OG004
WtHR Category: ≥0.6
Title
Measurements
OG00040.0
OG0010
OG0030
OG004
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 12: 1.0 mg Weeks 13 to 16: 1.7 mg Weeks 17 to 71: 2.4 mg.
Units
Counts
Participants
OG00030
OG00128
OG00237
OG00339
OG00448
OG00539
OG00639
OG00743
OG00839
Title
Denominators
Categories
WtHR Category: <0.5
Title
Measurements
OG0000
OG0010
OG0025.4
OG0032.6
OG0042.1
OG0050
OG0067.7
OG0072.3
OG00815.4
WtHR Category: 0.5-0.59
Title
Measurements
OG00020.0
OG00117.9
OG00221.6
OG003
WtHR Category: ≥0.6
Title
Measurements
OG00080.0
OG00182.1
OG00273.0
OG003
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00034
OG00128
OG00233
OG00344
OG00449
OG00540
OG00641
OG00739
OG00843
Title
Denominators
Categories
Title
Measurements
OG000-0.01± 0.05
OG001-0.20± 0.04
OG002-0.17± 0.06
OG003-0.34± 0.03
OG004-0.39± 0.03
OG005-0.37± 0.03
OG006-0.56± 0.04
OG007-0.44± 0.03
OG008-0.48± 0.03
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00037
OG00138
OG00238
OG00346
OG00446
OG00541
OG00634
OG00739
OG00836
Title
Denominators
Categories
Title
Measurements
OG0006.91± 2.33
OG0019.74± 1.48
OG00211.61± 1.62
OG00311.50± 1.56
OG00411.02± 1.97
OG00512.20± 1.89
OG00612.75± 1.92
OG00712.71± 1.94
OG00812.45± 1.93
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00037
OG00138
OG00238
OG00346
OG00446
OG00541
OG00634
OG00739
OG00836
Title
Denominators
Categories
Title
Measurements
OG0006.47± 2.11
OG0014.69± 1.98
OG0029.70± 1.65
OG00311.95± 1.56
OG00412.26± 1.49
OG00512.96± 2.02
OG00610.09± 2.11
OG00713.82± 1.62
OG00813.31± 1.45
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00033
OG00129
OG00234
OG00344
OG00445
OG00539
OG00634
OG00734
OG00839
Title
Denominators
Categories
Title
Measurements
OG00011.30± 1.80
OG00111.72± 2.51
OG00213.41± 1.64
OG00311.68± 2.42
OG00411.58± 2.14
OG00516.34± 1.55
OG00615.14± 1.82
OG00715.27± 1.97
OG00818.25± 2.19
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00033
OG00129
OG00234
OG00344
OG00445
OG00539
OG00634
OG00734
OG00839
Title
Denominators
Categories
Title
Measurements
OG00010.02± 2.08
OG0018.32± 2.00
OG00211.31± 1.77
OG00313.62± 1.79
OG00414.27± 1.67
OG00515.99± 1.90
OG00616.42± 1.92
OG00717.03± 1.60
OG00817.69± 1.90
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00024
OG00123
OG00228
OG00335
OG00441
OG00531
OG00631
OG00735
OG00834
Title
Denominators
Categories
Title
Measurements
OG0007.35± 3.81
OG00113.70± 2.65
OG00215.90± 1.62
OG00314.06± 1.75
OG00413.52± 2.28
OG00517.36± 1.77
OG00614.41± 1.97
OG00717.04± 2.20
OG00820.91± 1.76
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00024
OG00123
OG00228
OG00335
OG00441
OG00531
OG00631
OG00735
OG00834
Title
Denominators
Categories
Title
Measurements
OG0008.03± 3.49
OG0016.96± 3.02
OG00212.28± 1.91
OG00313.84± 2.10
OG00413.96± 2.04
OG00516.98± 1.91
OG00614.37± 2.12
OG00718.26± 1.76
OG00817.85± 1.59
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00037
OG00138
OG00239
OG00345
OG00447
OG00544
OG00638
OG00742
OG00836
Title
Denominators
Categories
Physical Function Score
Title
Measurements
OG0007.973± 15.919
OG00113.289± 13.115
OG00213.974± 13.726
OG00316.667± 14.616
OG00417.447± 16.677
OG00514.659± 16.474
OG00612.105± 22.680
OG00718.690± 19.818
OG00821.667± 17.113
Total score
Title
Measurements
OG0008.142± 11.538
OG00110.789± 10.363
OG00215.513± 11.868
OG003
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
Units
Counts
Participants
OG00034
OG00129
OG00235
OG00343
OG00445
OG00540
OG00637
OG00736
OG00839
Title
Denominators
Categories
Physical Function Score
Title
Measurements
OG00013.45± 2.37
OG00117.96± 2.37
OG00219.39± 2.09
OG00316.98± 2.07
OG00421.39± 2.14
OG00520.62± 2.62
OG00623.21± 2.97
OG00726.69± 2.30
OG00822.96± 2.00
Total Score
Title
Measurements
OG00013.44± 1.99
OG00115.62± 1.92
OG00218.52± 2.15
OG003
OG002
30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
OG003
Placebo + 1.0 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG004
Placebo + 2.4 mg Semaglutide
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG005
10 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG006
10 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 12: 1.0 mg
Weeks 13 to 16: 1.7 mg
Weeks 17 to 71: 2.4 mg
OG007
30 mg/kg Bimagrumab + 1.0 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg
Weeks 5 to 8: 0.5 mg
Weeks 9 to 71: 1.0 mg
OG008
30 mg/kg Bimagrumab + 2.4 mg Semaglutide
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule: