Investigation of Safety and Efficacy of Once-daily Semagl... | NCT02453711 | Trialant
NCT02453711
Sponsor
Novo Nordisk A/S
Status
Completed
Last Update Posted
Apr 17, 2020Actual
Enrollment
957Actual
Phase
Phase 2
Conditions
Metabolism and Nutrition Disorder
Obesity
Interventions
semaglutide
liraglutide
placebo
Countries
United States
Australia
Belgium
Canada
Germany
Israel
Russia
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02453711
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NN9536-4153
Secondary IDs
ID
Type
Description
Link
2014-001540-38
EudraCT Number
U1111-1155-4660
Other Identifier
WHO
Brief Title
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Official Title
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Acronym
Not provided
Organization
Novo Nordisk A/SINDUSTRY
Status Module
Record Verification Date
Apr 2020
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
Oct 1, 2015Actual
Primary Completion Date
Mar 30, 2017Actual
Completion Date
Apr 12, 2017Actual
First Submitted Date
May 21, 2015
First Submission Date that Met QC Criteria
May 21, 2015
First Posted Date
May 25, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 18, 2020
Results First Submitted that Met QC Criteria
Apr 14, 2020
Results First Posted Date
Apr 17, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 21, 2018
Certification/Extension First Submitted that Passed QC Review
Mar 21, 2018
Certification/Extension First Posted Date
Mar 22, 2018Actual
Last Update Submitted Date
Apr 14, 2020
Last Update Posted Date
Apr 17, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novo Nordisk A/SINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.
Detailed Description
Not provided
Conditions Module
Conditions
Metabolism and Nutrition Disorder
Obesity
Keywords
Not provided
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
957Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Sema 0.05 mg
Experimental
Dose 0.05 mg
Drug: semaglutide
Sema 0.1 mg
Experimental
Dose 0.05 or 0.1 mg with dose escalation every fourth week
Drug: semaglutide
Sema 0.2 mg
Experimental
Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week
Drug: semaglutide
Sema 0.3 mg
Experimental
Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week
Drug: semaglutide
Sema 0.4 mg
Experimental
Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week
Drug: semaglutide
Sema 0.3 mg (fast dose escalation)
Experimental
Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week
Interventions
Name
Type
Description
Arm Group Labels
Other Names
semaglutide
Drug
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Sema 0.05 mg
Sema 0.1 mg
Sema 0.2 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Relative Change in Body Weight (%)
Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Secondary Outcomes
Measure
Description
Time Frame
Participants With Weight Loss of ≥5% of Baseline Body Weight
Presented results are percentage of participants who lost more than or equal to 5% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age 18 years or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0 kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) - Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - History of major depressive disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Kolotkin RL, Williams VSL, Ervin CM, Williams N, Meincke HH, Qin S, von Huth Smith L, Fehnel SE. Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version. Clin Obes. 2019 Jun;9(3):e12310. doi: 10.1111/cob.12310. Epub 2019 Apr 16.
Design:Participants were randomised to 1 of the 16 parallel treatment arms in a 6:1 ratio (active:placebo) to receive either:A)Semaglutide 0.05/0.1/0.2/0.3/0.4 mg; dose escalation every 4th week B)Semaglutide 0.3/0.4 mg; dose escalation every second week C)Liraglutide 3.0 mg;dose escalation every week D)Placebo;matching each of the active treatment
Recruitment Details
The trial was conducted at 71 sites in 8 countries as follows: Australia: 5, Belgium: 5, Canada: 9, Germany: 6, Israel: 7, Russian Federation: 10, United Kingdom (UK):8, United States (US): 21. Along with this, recruitment of participants was planned at 3 sites (1 each in Germany, Russian Federation, and US), but where no participants were screened
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg subcutaneous (s.c.; under the skin) injections for 52 weeks.
FG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
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
5
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
Oct 24, 2017
Mar 18, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: semaglutide
Sema 0.4 mg (fast dose escalation)
Experimental
Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week
Drug: semaglutide
Lira 3.0 mg
Active Comparator
Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week
Drug: liraglutide
Placebo Sema 0.05 mg
Placebo Comparator
Placebo arm matching active arm Sema 0.05 mg
Drug: placebo
Placebo Sema 0.1 mg
Placebo Comparator
Placebo arm matching active arm Sema 0.1 mg
Drug: placebo
Placebo Sema 0.2 mg
Placebo Comparator
Placebo arm matching active arm Sema 0.2 mg
Drug: placebo
Placebo Sema 0.3 mg
Placebo Comparator
Placebo arm matching active arm Sema 0.3 mg
Drug: placebo
Placebo Sema 0.4 mg
Placebo Comparator
Placebo arm matching active arm Sema 0.4 mg
Drug: placebo
Placebo Sema 0.3 mg (fast dose escalation)
Placebo Comparator
Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)
Drug: placebo
Placebo Sema 0.4 mg (fast dose escalation)
Placebo Comparator
Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)
Drug: placebo
Placebo Lira 3.0 mg
Placebo Comparator
Placebo arm matching active arm Lira 3.0 mg
Drug: placebo
Sema 0.3 mg
Sema 0.3 mg (fast dose escalation)
Sema 0.4 mg
Sema 0.4 mg (fast dose escalation)
liraglutide
Drug
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Lira 3.0 mg
placebo
Drug
Once-daily subcutaneous (s.c., under the skin) administration.
Placebo Lira 3.0 mg
Placebo Sema 0.05 mg
Placebo Sema 0.1 mg
Placebo Sema 0.2 mg
Placebo Sema 0.3 mg
Placebo Sema 0.3 mg (fast dose escalation)
Placebo Sema 0.4 mg
Placebo Sema 0.4 mg (fast dose escalation)
Week 52
Participants With Weight Loss of ≥10% of Baseline Body Weight
Presented results are percentage of participants who lost more than or equal to 10% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Week 52
Change in Body Weight (kg)
Change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist circumference as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Change in Waist to Hip Circumference Ratio
Change from baseline (week 0) in waist to hip circumference ratio was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist to hip circumference ratio as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Change in BMI
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline BMI as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Change in HbA1c
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline HbA1c as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Change in FPG
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline FPG as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)
The categorisation of glycaemic status as described in the protocol was not aligned with the usual diagnosis criteria which require repeated testing of blood glucose to confirm the diagnosis and allows for the diagnosis to be made based on random glucose assessments and/or 2-hour glucose assessments during an oral glucose tolerance test. Therefore, data were not collected for this outcome measure.
Week 0, Week 52
Change in SBP
Change from baseline (week 0) in systolic blood pressure (SBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline SBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Change in DBP
Change from baseline (week 0) in diastolic blood pressure (DBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline DBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)
Change from baseline (week 0) in lipids (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and respective baseline lipid value as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. Free fatty acid (FFA) results are not presented as the values were considered invalid. The shipment of the samples to be tested for FFA was not as per the requirement.
Week 0, Week 52
Change in hsCRP
Change from baseline (week 0) in high-sensitivity C-reactive protein (hsCRP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline hsCRP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52
Change in IWQoL Lite
The planned analyses of the Impact of Weight on Quality of Life Lite (IWQoL-Lite) for Clinical Trials scores were not performed. The measure was still under development, and Novo Nordisk had not obtained a validated scoring of the instrument by the time of analysis of the trial results. Therefore, the total and subdomain scores on the IWQoL-Lite could not be provided.
Week 0, Week 52
Change in SF-36
Short Form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the in-trial observation period.
Week 0, Week 52
Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)
Participants' status on receiving concomitant medication (antihypertensive and lipid-lowering medications) at week 0 (yes/no) and week 52 (decreased, no change, increased or missing) are presented. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, Week 52
Compliance With Nutritional Counselling
This outcome measure presents "nutritional compliance results" recorded at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52. Nutritional compliance was recorded on a 0 to 10 numeric rating scale (NRS), with higher scores representing better compliance.
Week 4-52
Number of AEs During the Trial
Adverse events (AEs) were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0-59
Number of Hypoglycaemic Episodes During the Trial
Hypoglycaemic episodes were identified by either: 1) Subject reporting of symptoms of hypoglycaemia (low blood sugar) or 2) fasting plasma glucose (FPG) values ≤3.9 mmol/L (70 mg/dL) from blood sampling at site visits. Hypoglycaemic episodes were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0-59
Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week
Presented results are the number of nausea, vomiting, diarrhoea, and constipation events recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 0-59
Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score
This outcome measure presents results recorded at week 52. If a participant experienced an event of nausea within 24 hours prior to a site visit, a nausea questionnaire had to be completed. Participants experiencing such events were to answer 5 different categories in the questionnaire ('duration of nausea', 'time from the latest injection of trial product to the onset of nausea', 'time from last food intake to the onset of nausea', 'nausea accompanied by vomiting (yes/no)' and 'severity of nausea (worst during episode)'). Severity of nausea was recorded on a 0 to 10 numeric rating scale (NRS), where 0 = 'No nausea' and 10 = 'Nausea as bad as it could be'. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Week 52
Change in ECG
Number of participants with electrocardiogram (ECG) results, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" was recorded at baseline (week 0) and week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Pulse
Change from baseline (week 0) in pulse rate was evaluated at week 52. Analysis of observed data using a mixed model for repeated measurements (MMRM) with treatment, region and sex as factors and baseline pulse as covariate, all nested within visit. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Haematology: Haemoglobin
Change from baseline (week 0) in haemoglobin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Haematology: Haematocrit
Change from baseline (week 0) in haematocrit was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Haematology: Thrombocytes, Leucocytes and Differential Count
Change from baseline (week 0) in haematological parameters, "thrombocytes, leucocytes and differential cell count (eosinophils, neutrophils, basophils, monocytes and lymphocytes)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Haematology: Erythrocytes
Change from baseline (week 0) in erythrocytes was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Biochemistry: Creatinine and Bilirubin (Total)
Change from baseline (week 0) in biochemistry parameters, "creatinine and bilirubin (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
Change from baseline (week 0) in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)
Change from baseline (week 0) in biochemistry parameters, "urea, sodium, potassium and calcium (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Biochemistry: Albumin
Change from baseline (week 0) in albumin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Biochemistry: Calcitonin
Change from baseline (week 0) in calcitonin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Biochemistry: TSH
Change from baseline (week 0) in thyroid stimulating hormone (TSH) was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Change in Mental Health Assessed by C-SSRS
Presented results are the number of participants with Columbia Suicidality Severity Rating Scale (C-SSRS) results recorded during baseline (week 0) and post baseline (week 4-52) visits. For classification of the events reported on the C-SSRS, the following categories were used: 1) Suicidal ideation, 2) Suicidal behaviour and 3) Non-suicidal self-injurious behaviour. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0 and Week 4-59
Change in Mental Health Assessed by PHQ-9
Patient health questionnaire-9 (PHQ-9) was recorded at baseline (week 0) and week 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. On the PHQ-9, the participant rates the frequency of 9 items on a scale from 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Week 0, week 52
Anti-semaglutide Antibodies During and After Treatment
Participants were tested for anti-semaglutide antibodies from week 0 (post treatment) to week 52 (at weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52). This outcome measure is applicable only for the semaglutide treatment arms.
Week 0-52
San Diego
California
92108
United States
Novo Nordisk Investigational Site
Golden
Colorado
80401
United States
Novo Nordisk Investigational Site
Waterbury
Connecticut
06708
United States
Novo Nordisk Investigational Site
Washington D.C.
District of Columbia
20011
United States
Novo Nordisk Investigational Site
Crystal River
Florida
34429
United States
Novo Nordisk Investigational Site
Jacksonville
Florida
32205
United States
Novo Nordisk Investigational Site
Jacksonville
Florida
32216
United States
Novo Nordisk Investigational Site
Plantation
Florida
33324
United States
Novo Nordisk Investigational Site
Elkridge
Maryland
21075-6437
United States
Novo Nordisk Investigational Site
Rochester
New York
14609
United States
Novo Nordisk Investigational Site
Cincinnati
Ohio
45219
United States
Novo Nordisk Investigational Site
Wadsworth
Ohio
44281
United States
Novo Nordisk Investigational Site
Portland
Oregon
97239
United States
Novo Nordisk Investigational Site
Charleston
South Carolina
29425
United States
Novo Nordisk Investigational Site
Greer
South Carolina
29651
United States
Novo Nordisk Investigational Site
Bristol
Tennessee
37620-7352
United States
Novo Nordisk Investigational Site
Dallas
Texas
75251
United States
Novo Nordisk Investigational Site
Round Rock
Texas
78681
United States
Novo Nordisk Investigational Site
Sugar Land
Texas
77479
United States
Novo Nordisk Investigational Site
Arlington
Virginia
22206
United States
Novo Nordisk Investigational Site
Richmond
Virginia
23294
United States
Novo Nordisk Investigational Site
Camperdown
New South Wales
2050
Australia
Novo Nordisk Investigational Site
Merewether
New South Wales
2291
Australia
Novo Nordisk Investigational Site
St Leonards
New South Wales
2065
Australia
Novo Nordisk Investigational Site
Heidelberg Heights
Victoria
3081
Australia
Novo Nordisk Investigational Site
Melbourne
Victoria
3004
Australia
Novo Nordisk Investigational Site
Brussels
1200
Belgium
Novo Nordisk Investigational Site
Edegem
2650
Belgium
Novo Nordisk Investigational Site
Leuven
3000
Belgium
Novo Nordisk Investigational Site
Liège
4000
Belgium
Novo Nordisk Investigational Site
Mons
7000
Belgium
Novo Nordisk Investigational Site
Calgary
Alberta
T2V 4J2
Canada
Novo Nordisk Investigational Site
Surrey
British Columbia
V3S 2N6
Canada
Novo Nordisk Investigational Site
Moncton
New Brunswick
E1G 1A7
Canada
Novo Nordisk Investigational Site
Halifax
Nova Scotia
B3H 2Y9
Canada
Novo Nordisk Investigational Site
Hamilton
Ontario
L8L 5G8
Canada
Novo Nordisk Investigational Site
Hamilton
Ontario
L8M 1K7
Canada
Novo Nordisk Investigational Site
Toronto
Ontario
M4P 1P2
Canada
Novo Nordisk Investigational Site
Montreal
Quebec
H4N 2W2
Canada
Novo Nordisk Investigational Site
Québec
G1V 4G2
Canada
Novo Nordisk Investigational Site
Dresden
01219
Germany
Novo Nordisk Investigational Site
Dresden
01307
Germany
Novo Nordisk Investigational Site
Duisburg
47051
Germany
Novo Nordisk Investigational Site
Leipzig
04103
Germany
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach
66386
Germany
Novo Nordisk Investigational Site
Stuttgart
70378
Germany
Novo Nordisk Investigational Site
Wangen
88239
Germany
Novo Nordisk Investigational Site
Haifa
31096
Israel
Novo Nordisk Investigational Site
Jerusalem
91120
Israel
Novo Nordisk Investigational Site
Kfar Saba
44281
Israel
Novo Nordisk Investigational Site
Petah Tikva
49100
Israel
Novo Nordisk Investigational Site
Petah Tikva
49372
Israel
Novo Nordisk Investigational Site
Tel Aviv
64239
Israel
Novo Nordisk Investigational Site
Tel Litwinsky
52621
Israel
Novo Nordisk Investigational Site
Moscow
101990
Russia
Novo Nordisk Investigational Site
Moscow
109240
Russia
Novo Nordisk Investigational Site
Moscow
115478
Russia
Novo Nordisk Investigational Site
Moscow
117036
Russia
Novo Nordisk Investigational Site
Novosibirsk
630047
Russia
Novo Nordisk Investigational Site
Penza
440026
Russia
Novo Nordisk Investigational Site
Saint Petersburg
191015
Russia
Novo Nordisk Investigational Site
Tyumen
625023
Russia
Novo Nordisk Investigational Site
Voronezh
394018
Russia
Novo Nordisk Investigational Site
Yaroslavl
150003
Russia
Novo Nordisk Investigational Site
Yaroslavl
150062
Russia
Novo Nordisk Investigational Site
Bristol
BS10 5NB
United Kingdom
Novo Nordisk Investigational Site
Cambridge
CB2 0QQ
United Kingdom
Novo Nordisk Investigational Site
Glasgow
G31 2ER
United Kingdom
Novo Nordisk Investigational Site
Liverpool
L9 7AL
United Kingdom
Novo Nordisk Investigational Site
London
SE1 9RT
United Kingdom
Novo Nordisk Investigational Site
Luton
LU4 0DZ
United Kingdom
Novo Nordisk Investigational Site
Norwich
NR4 7TJ
United Kingdom
Novo Nordisk Investigational Site
Rotherham
S651DA
United Kingdom
O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.
FG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
FG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
FG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
FG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
FG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
FG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
FG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
FG000103 subjects
FG001102 subjects
FG002103 subjects
FG003103 subjects
FG004102 subjects
FG005102 subjects
FG006103 subjects
FG007103 subjects
FG008136 subjects
Full Analysis Set
FG000103 subjects
FG001102 subjects
FG002103 subjects
FG003103 subjects
FG004102 subjects
FG005102 subjects
FG006103 subjects
FG007103 subjects
FG008136 subjects
Safety Analysis Set
FG000103 subjects
FG001102 subjects
FG002103 subjects
FG003103 subjects
FG004102 subjects
FG005102 subjects
FG006103 subjects
FG007103 subjects
FG008136 subjects
COMPLETED
FG00092 subjects
FG00195 subjects
FG00294 subjects
FG00396 subjects
FG004100 subjects
FG00596 subjects
FG006100 subjects
FG00796 subjects
FG008123 subjects
NOT COMPLETED
FG00011 subjects
FG0017 subjects
FG0029 subjects
FG0037 subjects
FG0042 subjects
FG0056 subjects
FG0063 subjects
FG0077 subjects
FG00813 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0005 subjects
FG0014 subjects
FG0026 subjects
FG0034 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0087 subjects
Lost to Follow-up
FG0005 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Unclassified
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Overall number of baseline participants = full analysis set (FAS) which included all randomised participants. Number Analyzed = number of participants with available data.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
BG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
BG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
BG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
BG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
BG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
BG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
BG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
BG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000103
BG001102
BG002103
BG003103
BG004102
BG005102
BG006103
BG007103
BG008136
BG009957
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
ParticipantsBG000103
ParticipantsBG001102
ParticipantsBG002103
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000103
ParticipantsBG001102
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000103
ParticipantsBG001102
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000103
ParticipantsBG001102
ParticipantsBG002
Body weight
Mean
Standard Deviation
Kilogram (Kg)
Title
Denominators
Categories
ParticipantsBG000103
ParticipantsBG001102
ParticipantsBG002
Glycosylated haemoglobin (HbA1c)
Number Analyzed = number of participants in the FAS with available data. FAS included all randomised participants.
Mean
Standard Deviation
Percentage (%) of HbA1c
Title
Denominators
Categories
ParticipantsBG000103
ParticipantsBG001101
ParticipantsBG002
Fasting plasma glucose (FPG)
Number Analyzed = number of participants in the FAS with available data. FAS included all randomised participants.
Mean
Standard Deviation
Millimoles per litre (mmol/L)
Title
Denominators
Categories
ParticipantsBG000103
ParticipantsBG001102
ParticipantsBG002
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
Relative Change in Body Weight (%)
Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Percentage (%) of body weight
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00092
OG00196
OG00294
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.99± 0.85
OG001-8.62± 0.84
OG002-11.60± 0.85
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
J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.
ANCOVA
=0.0055
Treatment difference (%-points)
-3.70
Standard Error of the Mean
1.13
2-Sided
95
-6.55
-0.85
Semaglutide 0.05 mg - placebo pool
Other
Secondary
Participants With Weight Loss of ≥5% of Baseline Body Weight
Presented results are percentage of participants who lost more than or equal to 5% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Number
Percentage (%) of participants
Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Secondary
Participants With Weight Loss of ≥10% of Baseline Body Weight
Presented results are percentage of participants who lost more than or equal to 10% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Number
Percentage (%) of participants
Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Secondary
Change in Body Weight (kg)
Change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Kilogram (kg)
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist circumference as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Centimetre (cm)
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Waist to Hip Circumference Ratio
Change from baseline (week 0) in waist to hip circumference ratio was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist to hip circumference ratio as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Waist to hip circumference ratio
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Secondary
Change in BMI
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline BMI as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Kilogram per square meter (kg/m^2)
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in HbA1c
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline HbA1c as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Percentage of HbA1c
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in FPG
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline FPG as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Millimoles per litre (mmol/L)
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)
The categorisation of glycaemic status as described in the protocol was not aligned with the usual diagnosis criteria which require repeated testing of blood glucose to confirm the diagnosis and allows for the diagnosis to be made based on random glucose assessments and/or 2-hour glucose assessments during an oral glucose tolerance test. Therefore, data were not collected for this outcome measure.
Data were not collected for this outcome measure.
Posted
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in SBP
Change from baseline (week 0) in systolic blood pressure (SBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline SBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Millimeters of mercury (mmHg)
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in DBP
Change from baseline (week 0) in diastolic blood pressure (DBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline DBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Millimeters of mercury (mmHg)
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)
Change from baseline (week 0) in lipids (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and respective baseline lipid value as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. Free fatty acid (FFA) results are not presented as the values were considered invalid. The shipment of the samples to be tested for FFA was not as per the requirement.
Overall number of participants analyzed = FAS which included all randomised participants. Number Analyzed = number of participants in the FAS who contributed to the analysis.
Posted
Least Squares Mean
Standard Error
Millimoles per litre (mmol/L)
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
Secondary
Change in hsCRP
Change from baseline (week 0) in high-sensitivity C-reactive protein (hsCRP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline hsCRP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Least Squares Mean
Standard Error
Milligrams per decilitre (mg/dL)
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in IWQoL Lite
The planned analyses of the Impact of Weight on Quality of Life Lite (IWQoL-Lite) for Clinical Trials scores were not performed. The measure was still under development, and Novo Nordisk had not obtained a validated scoring of the instrument by the time of analysis of the trial results. Therefore, the total and subdomain scores on the IWQoL-Lite could not be provided.
This outcome measure was not analysed.
Posted
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Secondary
Change in SF-36
Short Form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the in-trial observation period.
Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.
Posted
Mean
Standard Deviation
Score on a scale
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
Secondary
Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)
Participants' status on receiving concomitant medication (antihypertensive and lipid-lowering medications) at week 0 (yes/no) and week 52 (decreased, no change, increased or missing) are presented. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = FAS which included all randomised participants. Number Analyzed = number of participants in the FAS with available data.
Posted
Count of Participants
Participants
Week 0, Week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Compliance With Nutritional Counselling
This outcome measure presents "nutritional compliance results" recorded at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52. Nutritional compliance was recorded on a 0 to 10 numeric rating scale (NRS), with higher scores representing better compliance.
Overall number of participants analyzed = FAS which included all randomised participants. Number Analyzed = number of participants in the FAS with available data.
Posted
Mean
Standard Deviation
Score on a scale
Week 4-52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Number of AEs During the Trial
Adverse events (AEs) were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment.
Posted
Number
Events
Week 0-59
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Secondary
Number of Hypoglycaemic Episodes During the Trial
Hypoglycaemic episodes were identified by either: 1) Subject reporting of symptoms of hypoglycaemia (low blood sugar) or 2) fasting plasma glucose (FPG) values ≤3.9 mmol/L (70 mg/dL) from blood sampling at site visits. Hypoglycaemic episodes were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment.
Posted
Number
Episodes
Week 0-59
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week
Presented results are the number of nausea, vomiting, diarrhoea, and constipation events recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment.
Posted
Number
Events
Week 0-59
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score
This outcome measure presents results recorded at week 52. If a participant experienced an event of nausea within 24 hours prior to a site visit, a nausea questionnaire had to be completed. Participants experiencing such events were to answer 5 different categories in the questionnaire ('duration of nausea', 'time from the latest injection of trial product to the onset of nausea', 'time from last food intake to the onset of nausea', 'nausea accompanied by vomiting (yes/no)' and 'severity of nausea (worst during episode)'). Severity of nausea was recorded on a 0 to 10 numeric rating scale (NRS), where 0 = 'No nausea' and 10 = 'Nausea as bad as it could be'. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Overall number of participants analyzed = number of participants in the SAS who experienced an event of nausea within 24 hours prior to the site visit at week 52. SAS included all participants receiving at least one dose of the randomised treatment.
Posted
Number
Events
Week 52
Nausea events
Nausea events
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
Secondary
Change in ECG
Number of participants with electrocardiogram (ECG) results, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" was recorded at baseline (week 0) and week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.
Posted
Count of Participants
Participants
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Pulse
Change from baseline (week 0) in pulse rate was evaluated at week 52. Analysis of observed data using a mixed model for repeated measurements (MMRM) with treatment, region and sex as factors and baseline pulse as covariate, all nested within visit. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.
Posted
Least Squares Mean
Standard Error
Beats per minute
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Haematology: Haemoglobin
Change from baseline (week 0) in haemoglobin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.
Posted
Mean
Standard Deviation
Millimoles per litre (mmol/L)
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Haematology: Haematocrit
Change from baseline (week 0) in haematocrit was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.
Posted
Mean
Standard Deviation
Percentage of red blood cells
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Haematology: Thrombocytes, Leucocytes and Differential Count
Change from baseline (week 0) in haematological parameters, "thrombocytes, leucocytes and differential cell count (eosinophils, neutrophils, basophils, monocytes and lymphocytes)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.
Posted
Mean
Standard Deviation
10^9 cells/litre (L)
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Haematology: Erythrocytes
Change from baseline (week 0) in erythrocytes was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.
Posted
Mean
Standard Deviation
10^12 cells/litre (L)
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Biochemistry: Creatinine and Bilirubin (Total)
Change from baseline (week 0) in biochemistry parameters, "creatinine and bilirubin (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.
Posted
Mean
Standard Deviation
Micromole/litre (umol/L)
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
Change from baseline (week 0) in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.
Posted
Mean
Standard Deviation
Unit/litre (U/L)
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)
Change from baseline (week 0) in biochemistry parameters, "urea, sodium, potassium and calcium (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.
Posted
Mean
Standard Deviation
Millimole/litre (mmol/L)
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Biochemistry: Albumin
Change from baseline (week 0) in albumin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.
Posted
Mean
Standard Deviation
Gram/decilitre (g/dL)
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Biochemistry: Calcitonin
Change from baseline (week 0) in calcitonin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = number of female participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.
Posted
Mean
Standard Deviation
Nanogram/litre (ng/L)
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Biochemistry: TSH
Change from baseline (week 0) in thyroid stimulating hormone (TSH) was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.
Posted
Mean
Standard Deviation
Milli-international units/litre (mIU/L)
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
Secondary
Change in Mental Health Assessed by C-SSRS
Presented results are the number of participants with Columbia Suicidality Severity Rating Scale (C-SSRS) results recorded during baseline (week 0) and post baseline (week 4-52) visits. For classification of the events reported on the C-SSRS, the following categories were used: 1) Suicidal ideation, 2) Suicidal behaviour and 3) Non-suicidal self-injurious behaviour. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.
Posted
Count of Participants
Participants
Week 0 and Week 4-59
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Secondary
Change in Mental Health Assessed by PHQ-9
Patient health questionnaire-9 (PHQ-9) was recorded at baseline (week 0) and week 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. On the PHQ-9, the participant rates the frequency of 9 items on a scale from 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.
Posted
Mean
Standard Deviation
Score on a scale
Week 0, week 52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
Secondary
Anti-semaglutide Antibodies During and After Treatment
Participants were tested for anti-semaglutide antibodies from week 0 (post treatment) to week 52 (at weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52). This outcome measure is applicable only for the semaglutide treatment arms.
Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment.
Posted
Count of Participants
Participants
Week 0-52
ID
Title
Description
OG000
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
OG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Time Frame
Week 0 up to Week 59 (treatment period: week 0 to week 52 + follow-up period: week 53 to week 59).
Description
All AEs mentioned here are treatment-emergent adverse events (TEAEs), which was defined as any AE reported after first trial product administration and until last trial product administration with a 7-week follow-up period. Results are based on the safety analysis set, which included all subjects receiving at least 1 dose of randomised treatment.
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
Semaglutide 0.05 mg
Participants received once daily semaglutide 0.05 mg s.c. injections for 52 weeks.
0
103
13
103
83
103
EG001
Semaglutide 0.1 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 52).
0
102
8
102
87
102
EG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
0
103
5
103
84
103
EG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
0
103
6
103
85
103
EG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
0
102
13
102
90
102
EG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
0
102
6
102
91
102
EG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
1
103
7
103
88
103
EG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
0
103
4
103
83
103
EG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Cardiac pacemaker insertion
Surgical and medical procedures
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0021 events1 affected103 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Food allergy
Immune system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Gastrectomy
Surgical and medical procedures
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0021 events1 affected103 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Gastroenteritis Escherichia coli
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Gastrointestinal anastomotic leak
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Headache
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Human chorionic gonadotropin increased
Investigations
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Infectious colitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Intestinal scarring
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Livedo reticularis
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Muscle enzyme increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0021 events1 affected103 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0003 events3 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Ovarian cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Percutaneous coronary intervention
Surgical and medical procedures
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0021 events1 affected103 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Transitional cell cancer of the renal pelvis and ureter
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Vascular insufficiency
Vascular disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Very long-chain acyl-coenzyme A dehydrogenase deficiency
Congenital, familial and genetic disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0021 events1 affected103 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0021 events1 affected103 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected103 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0013 events3 affected102 at risk
EG0027 events6 affected103 at risk
EG0032 events2 affected103 at risk
EG0044 events3 affected102 at risk
EG0056 events6 affected102 at risk
EG0065 events4 affected103 at risk
EG0073 events3 affected103 at risk
EG0084 events4 affected136 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0003 events3 affected103 at risk
EG0018 events7 affected102 at risk
EG0026 events4 affected103 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0008 events5 affected103 at risk
EG0016 events3 affected102 at risk
EG00218 events16 affected103 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0002 events2 affected103 at risk
EG0014 events4 affected102 at risk
EG0026 events6 affected103 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0013 events3 affected102 at risk
EG0021 events1 affected103 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0001 events1 affected103 at risk
EG0010 events0 affected102 at risk
EG0026 events6 affected103 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG0009 events7 affected103 at risk
EG00113 events9 affected102 at risk
EG0027 events6 affected103 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19
Systematic Assessment
EG00017 events8 affected103 at risk
EG00116 events11 affected102 at risk
EG0026 events6 affected103 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 19
Systematic Assessment
EG0000 events0 affected103 at risk
EG0016 events6 affected102 at risk
EG0021 events1 affected103 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0006 events4 affected103 at risk
EG0015 events5 affected102 at risk
EG0026 events4 affected103 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG00015 events13 affected103 at risk
EG00127 events22 affected102 at risk
EG00233 events26 affected103 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 19
Systematic Assessment
EG0004 events4 affected103 at risk
EG0011 events1 affected102 at risk
EG0022 events2 affected103 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0005 events5 affected103 at risk
EG0015 events5 affected102 at risk
EG0023 events3 affected103 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19
Systematic Assessment
EG0008 events8 affected103 at risk
EG00117 events17 affected102 at risk
EG00214 events13 affected103 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG00029 events20 affected103 at risk
EG00137 events25 affected102 at risk
EG00260 events35 affected103 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0003 events3 affected103 at risk
EG0016 events6 affected102 at risk
EG0029 events9 affected103 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0005 events3 affected103 at risk
EG0018 events8 affected102 at risk
EG0028 events6 affected103 at risk
EG003
Early satiety
General disorders
MedDRA 19
Systematic Assessment
EG0003 events3 affected103 at risk
EG0014 events4 affected102 at risk
EG0025 events5 affected103 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0004 events4 affected103 at risk
EG00113 events8 affected102 at risk
EG00220 events14 affected103 at risk
EG003
Fatigue
General disorders
MedDRA 19
Systematic Assessment
EG0004 events4 affected103 at risk
EG0017 events7 affected102 at risk
EG0027 events7 affected103 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0004 events4 affected103 at risk
EG0014 events4 affected102 at risk
EG0024 events3 affected103 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0007 events5 affected103 at risk
EG00115 events11 affected102 at risk
EG0026 events6 affected103 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG0008 events8 affected103 at risk
EG0019 events9 affected102 at risk
EG0028 events8 affected103 at risk
EG003
Headache
Nervous system disorders
MedDRA 19
Systematic Assessment
EG0009 events7 affected103 at risk
EG00120 events15 affected102 at risk
EG00212 events10 affected103 at risk
EG003
Influenza
Infections and infestations
MedDRA 19
Systematic Assessment
EG0002 events2 affected103 at risk
EG00114 events10 affected102 at risk
EG0026 events4 affected103 at risk
EG003
Injection site bruising
General disorders
MedDRA 19
Systematic Assessment
EG0004 events3 affected103 at risk
EG0015 events5 affected102 at risk
EG0028 events5 affected103 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19
Systematic Assessment
EG0003 events3 affected103 at risk
EG0016 events6 affected102 at risk
EG0022 events2 affected103 at risk
EG003
Lipase increased
Investigations
MedDRA 19
Systematic Assessment
EG0002 events2 affected103 at risk
EG0012 events2 affected102 at risk
EG0022 events2 affected103 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG00020 events16 affected103 at risk
EG00126 events23 affected102 at risk
EG00224 events19 affected103 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG00041 events32 affected103 at risk
EG00180 events42 affected102 at risk
EG00274 events45 affected103 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19
Systematic Assessment
EG0002 events2 affected103 at risk
EG0019 events8 affected102 at risk
EG0024 events3 affected103 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19
Systematic Assessment
EG0006 events4 affected103 at risk
EG0017 events5 affected102 at risk
EG00210 events7 affected103 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG00016 events12 affected103 at risk
EG00112 events10 affected102 at risk
EG00217 events13 affected103 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0003 events3 affected103 at risk
EG0016 events6 affected102 at risk
EG0025 events4 affected103 at risk
EG003
Viral infection
Infections and infestations
MedDRA 19
Systematic Assessment
EG0005 events5 affected103 at risk
EG0018 events6 affected102 at risk
EG0023 events3 affected103 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19
Systematic Assessment
EG00010 events8 affected103 at risk
EG00129 events18 affected102 at risk
EG00241 events24 affected103 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Hormones, Hormone Substitutes, and Hormone Antagonists
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0055 subjects
FG0062 subjects
FG0076 subjects
FG0086 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
103
ParticipantsBG004102
ParticipantsBG005102
ParticipantsBG006103
ParticipantsBG007103
ParticipantsBG008136
ParticipantsBG009957
Title
Measurements
BG00046.97± 12.80
BG00145.24± 12.62
BG00244.37± 11.24
BG00346.73± 12.02
BG00448.37± 13.44
BG00547.10± 12.05
BG00646.07± 13.51
BG00748.50± 11.22
BG00846.42± 12.80
BG00946.63± 12.46
103
ParticipantsBG003103
ParticipantsBG004102
ParticipantsBG005102
ParticipantsBG006103
ParticipantsBG007103
ParticipantsBG008136
ParticipantsBG009957
Title
Measurements
Female
BG00067
BG00166
BG00266
BG00366
BG00466
BG00566
BG00667
BG00767
BG00888
BG009619
Male
BG00036
BG00136
BG00237
BG00337
BG004
103
ParticipantsBG003103
ParticipantsBG004102
ParticipantsBG005102
ParticipantsBG006103
ParticipantsBG007103
ParticipantsBG008136
ParticipantsBG009957
Title
Measurements
White
BG00088
BG00176
BG00272
BG00374
BG00471
BG00576
BG00668
BG00778
BG00897
BG009700
Black or African American
BG0005
BG0017
BG00210
BG0033
BG004
Asian
BG0002
BG0010
BG0021
BG0030
BG004
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0031
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0030
BG004
Other
BG0000
BG0011
BG0020
BG0033
BG004
Not applicable
BG0008
BG00117
BG00220
BG00322
BG004
103
ParticipantsBG003103
ParticipantsBG004102
ParticipantsBG005102
ParticipantsBG006103
ParticipantsBG007103
ParticipantsBG008136
ParticipantsBG009957
Title
Measurements
Hispanic or Latino
BG0003
BG0017
BG0026
BG00313
BG0044
BG0056
BG0063
BG0076
BG0087
BG00955
Not Hispanic or Latino
BG00096
BG00186
BG00293
BG00379
BG004
Not applicable
BG0004
BG0019
BG0024
BG00311
BG004
103
ParticipantsBG003103
ParticipantsBG004102
ParticipantsBG005102
ParticipantsBG006103
ParticipantsBG007103
ParticipantsBG008136
ParticipantsBG009957
Title
Measurements
BG000111.29± 23.17
BG001111.31± 21.47
BG002114.49± 24.53
BG003111.51± 22.96
BG004113.20± 26.42
BG005108.11± 22.08
BG006109.56± 21.33
BG007108.71± 21.94
BG008114.19± 25.37
BG009111.48± 23.39
103
ParticipantsBG003103
ParticipantsBG004102
ParticipantsBG005102
ParticipantsBG006103
ParticipantsBG007103
ParticipantsBG008136
ParticipantsBG009956
Title
Measurements
BG0005.51± 0.35
BG0015.45± 0.43
BG0025.41± 0.39
BG0035.51± 0.38
BG0045.47± 0.42
BG0055.48± 0.41
BG0065.49± 0.42
BG0075.53± 0.38
BG0085.54± 0.38
BG0095.49± 0.40
103
ParticipantsBG003103
ParticipantsBG004101
ParticipantsBG005102
ParticipantsBG006103
ParticipantsBG007103
ParticipantsBG008136
ParticipantsBG009956
Title
Measurements
BG0005.48± 0.64
BG0015.48± 0.55
BG0025.41± 0.77
BG0035.48± 0.73
BG0045.40± 0.67
BG0055.43± 0.64
BG0065.54± 0.87
BG0075.55± 0.73
BG0085.50± 0.62
BG0095.48± 0.69
95
OG004100
OG00595
OG006100
OG00796
OG008123
-11.17
± 0.85
OG004-13.84± 0.83
OG005-11.38± 0.85
OG006-16.29± 0.83
OG007-7.76± 0.85
OG008-2.29± 0.74
OG001
OG008
J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.
ANCOVA
<0.0001
Treatment difference (%-points)
-6.32
Standard Error of the Mean
1.12
2-Sided
95
-9.16
-3.49
Semaglutide 0.1 mg - placebo pool
Other
OG002
OG008
J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.
ANCOVA
<0.0001
Treatment difference (%-points)
-9.31
Standard Error of the Mean
1.12
2-Sided
95
-12.15
-6.46
Semaglutide 0.2 mg - placebo pool
Other
OG003
OG008
J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.
ANCOVA
<0.0001
Treatment difference (%-points)
-8.88
Standard Error of the Mean
1.12
2-Sided
95
-11.72
-6.03
Semaglutide 0.3 mg - placebo pool
Other
OG004
OG008
J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.
ANCOVA
<0.0001
Treatment difference (%-points)
-11.55
Standard Error of the Mean
1.12
2-Sided
95
-14.38
-8.72
Semaglutide 0.4 mg - placebo pool
Other
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00092
OG00196
OG00294
OG00395
OG004100
OG00595
OG006100
OG00796
OG008123
Title
Denominators
Categories
Title
Measurements
OG00053.50
OG00167.49
OG00274.91
OG00380.52
OG00482.52
OG00572.19
OG00689.58
OG00766.12
OG00822.87
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00092
OG00196
OG00294
OG00395
OG004100
OG00595
OG006100
OG00796
OG008123
Title
Denominators
Categories
Title
Measurements
OG00018.94
OG00136.57
OG00255.95
OG00357.76
OG00464.61
OG00558.45
OG00671.91
OG00733.98
OG00810.08
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00092
OG00196
OG00294
OG00395
OG004100
OG00595
OG006100
OG00796
OG008123
Title
Denominators
Categories
Title
Measurements
OG000-6.66± 0.94
OG001-9.34± 0.93
OG002-12.30± 0.93
OG003-12.45± 0.93
OG004-15.15± 0.92
OG005-12.54± 0.93
OG006-17.36± 0.92
OG007-8.47± 0.93
OG008-2.48± 0.82
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00077
OG00188
OG00287
OG00388
OG00482
OG00573
OG00691
OG00786
OG008103
Title
Denominators
Categories
Title
Measurements
OG000-6.11± 0.93
OG001-8.75± 0.90
OG002-11.02± 0.89
OG003-10.91± 0.89
OG004-12.31± 0.91
OG005-11.06± 0.95
OG006-14.88± 0.88
OG007-8.35± 0.89
OG008-3.47± 0.81
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00077
OG00188
OG00287
OG00388
OG00482
OG00573
OG00691
OG00786
OG008103
Title
Denominators
Categories
Title
Measurements
OG000-0.01± 0.01
OG001-0.02± 0.01
OG002-0.02± 0.01
OG003-0.03± 0.01
OG004-0.02± 0.01
OG005-0.02± 0.01
OG006-0.03± 0.01
OG007-0.02± 0.01
OG008-0.01± 0.00
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00092
OG00196
OG00294
OG00395
OG004100
OG00595
OG006100
OG00796
OG008123
Title
Denominators
Categories
Title
Measurements
OG000-2.37± 0.33
OG001-3.36± 0.33
OG002-4.38± 0.33
OG003-4.40± 0.33
OG004-5.40± 0.33
OG005-4.48± 0.33
OG006-6.21± 0.33
OG007-3.03± 0.33
OG008-0.88± 0.29
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00077
OG00188
OG00287
OG00387
OG00482
OG00575
OG00691
OG00785
OG008103
Title
Denominators
Categories
Title
Measurements
OG000-0.13± 0.03
OG001-0.21± 0.03
OG002-0.28± 0.03
OG003-0.23± 0.03
OG004-0.29± 0.03
OG005-0.25± 0.03
OG006-0.34± 0.03
OG007-0.21± 0.03
OG008-0.01± 0.03
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00077
OG00188
OG00286
OG00388
OG00481
OG00575
OG00691
OG00786
OG008103
Title
Denominators
Categories
Title
Measurements
OG000-0.29± 0.06
OG001-0.35± 0.06
OG002-0.40± 0.06
OG003-0.39± 0.06
OG004-0.43± 0.06
OG005-0.38± 0.06
OG006-0.51± 0.06
OG007-0.35± 0.06
OG0080.01± 0.05
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00091
OG00196
OG00294
OG00395
OG004100
OG00595
OG006100
OG00796
OG008123
Title
Denominators
Categories
Title
Measurements
OG000-4.46± 1.20
OG001-5.76± 1.18
OG002-6.26± 1.19
OG003-6.41± 1.19
OG004-5.81± 1.16
OG005-6.07± 1.19
OG006-10.26± 1.16
OG007-5.45± 1.18
OG008-1.58± 1.04
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00091
OG00196
OG00294
OG00395
OG004100
OG00595
OG006100
OG00796
OG008123
Title
Denominators
Categories
Title
Measurements
OG000-2.55± 0.84
OG001-2.65± 0.82
OG002-4.09± 0.83
OG003-2.98± 0.83
OG004-3.61± 0.80
OG005-2.20± 0.83
OG006-5.52± 0.80
OG007-2.70± 0.82
OG008-1.50± 0.73
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Total cholesterol
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00387
ParticipantsOG00482
ParticipantsOG00574
ParticipantsOG00691
ParticipantsOG00785
ParticipantsOG008102
Title
Measurements
OG0000.96± 0.02
OG0010.95± 0.01
OG0020.93± 0.01
OG003
LDL cholesterol
ParticipantsOG00072
ParticipantsOG00187
ParticipantsOG00286
ParticipantsOG00385
HDL cholesterol
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00387
VLDL cholesterol
ParticipantsOG00076
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00387
Triglycerides
ParticipantsOG00076
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00387
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00077
OG00188
OG00287
OG00387
OG00482
OG00574
OG00691
OG00785
OG008102
Title
Denominators
Categories
Title
Measurements
OG0000.71± 0.07
OG0010.65± 0.06
OG0020.57± 0.05
OG0030.66± 0.06
OG0040.54± 0.05
OG0050.58± 0.05
OG0060.44± 0.04
OG0070.72± 0.06
OG0080.82± 0.07
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00027
OG00123
OG00220
OG00331
OG00433
OG00522
OG00624
OG00731
OG00837
Title
Denominators
Categories
Bodily pain
Title
Measurements
OG0001.85± 10.99
OG0013.01± 6.41
OG0024.27± 7.14
OG0033.82± 7.11
OG0045.16± 8.02
OG0051.88± 9.25
OG0065.11± 10.62
OG0072.48± 7.46
OG0081.21± 9.39
General health
Title
Measurements
OG0002.03± 5.98
OG0012.51± 7.23
OG0024.17± 6.52
OG003
Mental health
Title
Measurements
OG0000.42± 7.76
OG0010.24± 6.57
OG0022.82± 8.67
OG003
Physical functioning
Title
Measurements
OG0006.00± 6.92
OG0014.67± 8.17
OG0026.52± 5.91
OG003
Role-emotional
Title
Measurements
OG0003.31± 6.35
OG001-1.69± 6.61
OG0021.17± 7.03
OG003
Role-physical
Title
Measurements
OG0003.45± 8.24
OG0014.37± 10.23
OG0027.35± 8.85
OG003
Social functioning
Title
Measurements
OG0000.81± 6.54
OG0010.71± 7.04
OG0021.36± 7.69
OG003
Vitality
Title
Measurements
OG0001.73± 7.61
OG0015.16± 11.08
OG0028.90± 8.61
OG003
Physical component summary
Title
Measurements
OG0004.16± 7.70
OG0015.51± 8.04
OG0027.14± 6.38
OG003
Mental component summary
Title
Measurements
OG0000.25± 5.94
OG001-1.15± 6.67
OG0021.45± 8.54
OG003
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Week 0: Antihypertensive medication (Yes)
ParticipantsOG000103
ParticipantsOG001102
ParticipantsOG002103
ParticipantsOG003103
ParticipantsOG004102
ParticipantsOG005102
ParticipantsOG006103
ParticipantsOG007103
ParticipantsOG008136
Title
Measurements
OG00037
OG00131
OG00228
OG003
Week 0: Antihypertensive medication (No)
ParticipantsOG000103
ParticipantsOG001102
ParticipantsOG002103
ParticipantsOG003103
Week 52: Antihypertensive medication (Decreased)
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG003
Week 52: Antihypertensive medication (No change)
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG003
Week 52: Antihypertensive medication (Increased)
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG003
Week 52: Antihypertensive medication (Missing)
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
Week 0: Lipid-lowering medication (Yes)
ParticipantsOG000103
ParticipantsOG001102
ParticipantsOG002103
ParticipantsOG003103
Week 0: Lipid-lowering medication (No)
ParticipantsOG000103
ParticipantsOG001102
ParticipantsOG002103
ParticipantsOG003103
Week 52: Lipid-lowering medication (Decreased)
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
Week 52: Lipid-lowering medication (No change)
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
Week 52: Lipid-lowering medication (Increased)
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG003
Week 52: Lipid-lowering medication (Missing)
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Week-4
ParticipantsOG00097
ParticipantsOG00199
ParticipantsOG002100
ParticipantsOG00398
ParticipantsOG00499
ParticipantsOG00596
ParticipantsOG006101
ParticipantsOG007101
ParticipantsOG008131
Title
Measurements
OG0006.85± 1.99
OG0017.30± 1.96
OG0027.17± 1.89
OG003
Week-8
ParticipantsOG00097
ParticipantsOG00198
ParticipantsOG00295
ParticipantsOG00396
Week-12
ParticipantsOG00094
ParticipantsOG00193
ParticipantsOG00291
ParticipantsOG00395
Week-16
ParticipantsOG00085
ParticipantsOG00193
ParticipantsOG00288
ParticipantsOG00394
Week-20
ParticipantsOG00086
ParticipantsOG00189
ParticipantsOG00292
ParticipantsOG00392
Week-24
ParticipantsOG00086
ParticipantsOG00193
ParticipantsOG00289
ParticipantsOG00390
Week-28
ParticipantsOG00083
ParticipantsOG00191
ParticipantsOG00288
ParticipantsOG00391
Week-32
ParticipantsOG00078
ParticipantsOG00191
ParticipantsOG00290
ParticipantsOG00388
Week-36
ParticipantsOG00077
ParticipantsOG00189
ParticipantsOG00287
ParticipantsOG00388
Week-40
ParticipantsOG00078
ParticipantsOG00188
ParticipantsOG00286
ParticipantsOG00388
Week-44
ParticipantsOG00072
ParticipantsOG00187
ParticipantsOG00284
ParticipantsOG00384
Week-48
ParticipantsOG00074
ParticipantsOG00187
ParticipantsOG00285
ParticipantsOG00384
Week-52
ParticipantsOG00074
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00387
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Title
Measurements
OG000547
OG001730
OG002738
OG003587
OG004775
OG005737
OG006681
OG007612
OG008650
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Title
Measurements
OG0001
OG0016
OG0024
OG0038
OG00410
OG00520
OG00616
OG0074
OG00818
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Nausea
Title
Measurements
OG00041
OG00180
OG00274
OG00369
OG00494
OG005106
OG00697
OG00789
OG00830
Vomiting
Title
Measurements
OG00010
OG00129
OG00241
OG003
Diarrhoea
Title
Measurements
OG00029
OG00137
OG00261
OG003
Constipation
Title
Measurements
OG00015
OG00127
OG00233
OG003
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG0000
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Nausea events
OG0000
OG0011
OG0021
OG0030
OG004
Title
Denominators
Categories
Duration of nausea:<30 min
Title
Measurements
OG0010
OG0021
Duration of nausea: 30 min-2 hr
Title
Measurements
OG0010
OG0020
Duration of nausea: 2-4 hr
Title
Measurements
OG0010
OG0020
Duration of nausea: 4-8 hr
Title
Measurements
OG0011
OG0020
Duration of nausea: >8 hr
Title
Measurements
OG0010
OG0020
Latest injection to onset time: 0-3 hr
Title
Measurements
OG0010
OG0020
Latest injection to onset time: 3-6 hr
Title
Measurements
OG0010
OG0020
Latest injection to onset time: 6-12 hr
Title
Measurements
OG0011
OG0020
Latest injection to onset time: 12-18 hr
Title
Measurements
OG0010
OG0021
Latest injection to onset time: >18 hr
Title
Measurements
OG0010
OG0020
Last food intake to onset time: 0-1 hr
Title
Measurements
OG0010
OG0021
Last food intake to onset time: 1-2 hr
Title
Measurements
OG0011
OG0020
Last food intake to onset time: 2-3 hr
Title
Measurements
OG0010
OG0020
Last food intake to onset time: 3-6 hr
Title
Measurements
OG0010
OG0020
Last food intake to onset time: >6 hr
Title
Measurements
OG0010
OG0020
Nausea accompanied by vomiting (Yes)
Title
Measurements
OG0010
OG0020
Nausea accompanied by vomiting (No)
Title
Measurements
OG0011
OG0021
Severity of nausea: 0
Title
Measurements
OG0010
OG0020
Severity of nausea: 1
Title
Measurements
OG0010
OG0020
Severity of nausea: 2
Title
Measurements
OG0010
OG0020
Severity of nausea: 3
Title
Measurements
OG0010
OG0020
Severity of nausea: 4
Title
Measurements
OG0010
OG0021
Severity of nausea: 5
Title
Measurements
OG0011
OG0020
Severity of nausea: 6
Title
Measurements
OG0010
OG0020
Severity of nausea: 7
Title
Measurements
OG0010
OG0020
Severity of nausea: 8
Title
Measurements
OG0010
OG0020
Severity of nausea: 9
Title
Measurements
OG0010
OG0020
Severity of nausea: 10
Title
Measurements
OG0010
OG0020
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Week: 0
ParticipantsOG000103
ParticipantsOG001102
ParticipantsOG002103
ParticipantsOG003103
ParticipantsOG004102
ParticipantsOG005102
ParticipantsOG006103
ParticipantsOG007103
ParticipantsOG008136
Title
Measurements
Normal
OG00070
OG00169
OG00274
OG003
Week: 52
ParticipantsOG00082
ParticipantsOG00191
ParticipantsOG00287
ParticipantsOG00389
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000101
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008135
Title
Denominators
Categories
Title
Measurements
OG000-0.33± 0.88
OG0013.46± 0.83
OG0021.88± 0.84
OG0032.38± 0.83
OG0042.54± 0.85
OG0052.34± 0.89
OG0062.15± 0.82
OG0072.63± 0.84
OG008-0.86± 0.76
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00079
OG00188
OG00287
OG00386
OG00485
OG00575
OG00691
OG00784
OG008106
Title
Denominators
Categories
Title
Measurements
OG0000.01± 0.48
OG001-0.08± 0.65
OG002-0.02± 0.47
OG003-0.07± 0.51
OG0040.00± 0.50
OG005-0.07± 0.47
OG0060.02± 0.47
OG0070.11± 0.48
OG008-0.01± 0.45
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00079
OG00188
OG00287
OG00386
OG00485
OG00575
OG00691
OG00784
OG008106
Title
Denominators
Categories
Title
Measurements
OG000-0.25± 2.48
OG001-0.58± 3.28
OG002-0.42± 2.26
OG003-0.49± 2.67
OG004-0.31± 2.75
OG005-0.68± 2.82
OG006-0.15± 2.67
OG0070.26± 2.70
OG0080.26± 2.44
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Thrombocytes
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00286
ParticipantsOG00386
ParticipantsOG00485
ParticipantsOG00575
ParticipantsOG00691
ParticipantsOG00784
ParticipantsOG008104
Title
Measurements
OG000-2.08± 35.26
OG0012.95± 43.02
OG002-8.17± 42.59
OG003
Leucocytes
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00386
Eosinophils
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00386
Neutrophils
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00386
Basophils
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00386
Monocytes
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00386
Lymphocytes
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00386
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00079
OG00188
OG00287
OG00386
OG00485
OG00575
OG00691
OG00784
OG008106
Title
Denominators
Categories
Title
Measurements
OG000-0.01± 0.26
OG001-0.06± 0.35
OG002-0.03± 0.27
OG003-0.04± 0.25
OG004-0.01± 0.29
OG005-0.04± 0.24
OG006-0.01± 0.27
OG0070.05± 0.30
OG0080.04± 0.24
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Creatinine
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
ParticipantsOG00485
ParticipantsOG00576
ParticipantsOG00692
ParticipantsOG00786
ParticipantsOG008105
Title
Measurements
OG000-1.14± 6.53
OG001-0.85± 7.59
OG002-1.09± 6.11
OG003
Bilirubin (total)
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00387
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Creatinine kinase
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
ParticipantsOG00485
ParticipantsOG00576
ParticipantsOG00692
ParticipantsOG00786
ParticipantsOG008105
Title
Measurements
OG0000.53± 68.43
OG001-44.75± 266.88
OG002-13.20± 44.33
OG003
Amylase
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
Lipase
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
ALT
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00387
AST
ParticipantsOG00078
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00387
ALP
ParticipantsOG00078
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Urea
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
ParticipantsOG00485
ParticipantsOG00576
ParticipantsOG00692
ParticipantsOG00786
ParticipantsOG008105
Title
Measurements
OG000-0.04± 1.06
OG0010.16± 1.26
OG002-0.01± 1.21
OG003
Sodium
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
Potassium
ParticipantsOG00078
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
Calcium (total)
ParticipantsOG00079
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00388
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00079
OG00188
OG00287
OG00388
OG00485
OG00576
OG00692
OG00786
OG008105
Title
Denominators
Categories
Title
Measurements
OG0000.03± 0.18
OG0010.01± 0.21
OG0020.07± 0.20
OG0030.05± 0.21
OG0040.03± 0.22
OG0050.01± 0.21
OG0060.02± 0.23
OG0070.06± 0.18
OG0080.04± 0.20
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00054
OG00155
OG00254
OG00356
OG00458
OG00547
OG00659
OG00757
OG00864
Title
Denominators
Categories
Title
Measurements
OG0000.08± 0.71
OG0010.03± 1.07
OG0020.04± 0.44
OG0030.04± 0.18
OG0040.17± 0.79
OG005-0.01± 0.73
OG0060.20± 0.72
OG0070.29± 1.27
OG008-0.12± 2.16
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG00079
OG00188
OG00286
OG00388
OG00485
OG00576
OG00692
OG00786
OG008105
Title
Denominators
Categories
Title
Measurements
OG000-0.31± 1.62
OG001-0.10± 1.10
OG002-0.22± 0.85
OG003-0.18± 1.04
OG004-0.10± 0.96
OG005-0.12± 0.84
OG006-0.43± 1.01
OG0070.02± 0.88
OG008-0.07± 0.97
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Wk 0: Suicidal ideation
ParticipantsOG000102
ParticipantsOG001102
ParticipantsOG002103
ParticipantsOG003103
ParticipantsOG004102
ParticipantsOG005102
ParticipantsOG006103
ParticipantsOG007103
ParticipantsOG008136
Title
Measurements
OG0000
OG0010
OG0021
OG003
Wk 0: Suicidal behaviour
ParticipantsOG000102
ParticipantsOG001102
ParticipantsOG002103
ParticipantsOG003103
Wk 0: Non-suicidal self-injurious behaviour
ParticipantsOG000102
ParticipantsOG001102
ParticipantsOG002103
ParticipantsOG003103
Wk 4-59: Suicidal ideation
ParticipantsOG000100
ParticipantsOG001102
ParticipantsOG002102
ParticipantsOG003102
Wk 4-59: Suicidal behaviour
ParticipantsOG000100
ParticipantsOG001102
ParticipantsOG002102
ParticipantsOG003102
Wk 4-59: Non-suicidal self-injurious behaviour
ParticipantsOG000100
ParticipantsOG001102
ParticipantsOG002102
ParticipantsOG003
OG002
Semaglutide 0.2 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), and 0.2 mg (week 9 to week 52).
OG003
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).
OG007
Liraglutide 3.0 mg
Participants received once daily liraglutide s.c. injections for 52 weeks. Dose escalation was done at every week as following: 0.6 mg in week 1, 1.2 mg in week 2, 1.8 mg in week 3, 2.4 mg in week 4, and 3.0 mg from week 5 to week 52.
OG008
Placebo Pool
Participants received once daily placebo s.c injections (matching each of the active treatment arms: semaglutide 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg (dose escalation every fourth week); semaglutide 0.3 mg or 0.4 mg (dose escalation every second week); liraglutide 3.0 mg (dose escalation every week)).
Units
Counts
Participants
OG000103
OG001102
OG002103
OG003103
OG004102
OG005102
OG006103
OG007103
OG008136
Title
Denominators
Categories
Week 0
ParticipantsOG000103
ParticipantsOG001102
ParticipantsOG002103
ParticipantsOG003103
ParticipantsOG004102
ParticipantsOG005102
ParticipantsOG006103
ParticipantsOG007103
ParticipantsOG008136
Title
Measurements
OG0002.5± 3.4
OG0011.7± 2.1
OG0022.1± 2.6
OG003
Week 52
ParticipantsOG00077
ParticipantsOG00188
ParticipantsOG00287
ParticipantsOG00387
Semaglutide 0.3 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), and 0.3 mg (week 13 to week 52).
OG004
Semaglutide 0.4 mg
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every fourth week as following: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16), and 0.4 mg (week 17 to week 52).
OG005
Semaglutide 0.3 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), and 0.3 mg (week 7 to week 52).
OG006
Semaglutide 0.4 mg (Fast Escalation)
Participants received once daily semaglutide s.c. injections for 52 weeks. Dose escalation was done at every second week (fast escalation) as following: 0.05 mg (in weeks 1 and 2), 0.1 mg (in weeks 3 and 4), 0.2 mg (in weeks 5 and 6), 0.3 mg (in weeks 7 and 8), and 0.4 mg (week 9 to week 52).