A Study of LY3437943 in Participants Who Have Obesity or... | NCT04881760 | Trialant
NCT04881760
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 13, 2023Actual
Enrollment
338Actual
Phase
Phase 2
Conditions
Obesity
Overweight
Interventions
LY3437943
Placebo
Countries
United States
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT04881760
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
18122
Secondary IDs
ID
Type
Description
Link
J1I-MC-GZBF
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
Official Title
A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 2023
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
May 20, 2021Actual
Primary Completion Date
May 16, 2022Actual
Completion Date
Nov 22, 2022Actual
First Submitted Date
May 10, 2021
First Submission Date that Met QC Criteria
May 10, 2021
First Posted Date
May 11, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Aug 23, 2023
Results First Submitted that Met QC Criteria
Aug 23, 2023
Results First Posted Date
Sep 13, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 10, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
May 15, 2023Actual
Last Update Submitted Date
Aug 23, 2023
Last Update Posted Date
Sep 13, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a study of LY3437943 in participants who have obesity or are overweight. The main purpose is to learn more about how LY3437943 affects body weight loss. The study will last about 18 months and may include up to 18 visits.
Detailed Description
Not provided
Conditions Module
Conditions
Obesity
Overweight
Keywords
Nutritional or Metabolism Disorder
Weight Loss
Overnutrition
Incretins
Hormones
Physiological Effects of Drugs
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
338Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).
Drug: Placebo
1 milligram (mg) LY3437943
Experimental
Participants received 1 mg LY3437943 administered as SC injection QW.
Drug: LY3437943
4 mg LY3437943 (2 mg)
Experimental
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
Drug: LY3437943
4 mg LY3437943
Experimental
Participants received 4 mg LY3437943 administered as SC injection QW.
Drug: LY3437943
8 mg LY3437943 (2 mg)
Experimental
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
Drug: LY3437943
8 mg LY3437943 (4 mg)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3437943
Drug
Administered SC
1 milligram (mg) LY3437943
12 mg LY3437943 (2 mg)
4 mg LY3437943
4 mg LY3437943 (2 mg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Percent Change From Baseline in Body Weight
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
Baseline, Week 24
Secondary Outcomes
Measure
Description
Time Frame
Mean Percent Change From Baseline in Body Weight
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
Baseline, Week 48
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must have a Body Mass Index (BMI) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and <30 kg/m², with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease
Participants must be willing to learn how to self-inject study drug or receive an injection from a trained individual if visually impaired or with physical limitations, and follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice (for example, dietary changes and physical activity plan), maintain a study drug administration log, and complete required questionnaires
Exclusion Criteria:
Participants must not have type 1 or type 2 diabetes mellitus
Participants must not have had an increase or decrease in body weight > more than 5 kg (11 pounds) within the past 3 months
Participants must not have had surgery for obesity or plan to have such surgery during the study
Participants must not be using medications that promote weight loss or cause weight gain
Participants must not drink excessive amounts of alcohol (more than 14 units a week for women or more than 21 units a week for men)
Participants must not have used marijuana within the last 3 months.
Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months
Participants must not have active cancer within the last 5 years
Participants must not have uncontrolled high blood pressure
Participants must not have liver disease other than non-alcoholic fatty liver disease
Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
Participants must not have a history of acute or chronic pancreatitis symptomatic gallbladder disease or documented human immunodeficiency virus infection
Participants must not have a major problem with depression or other mental illness within the last 2 years
Participants must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)
Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Kanu C, Clucas C, Skalicky A, Samuelson A, Goetz I, Neff LM, Boye KS, Karn H. Development and Content Evaluation of the Eating Behavior and Appetite Questionnaire (EBAQ) for Individuals with Obesity. Adv Ther. 2026 Jan;43(1):150-164. doi: 10.1007/s12325-025-03386-2. Epub 2025 Nov 7.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Four maintenance doses of LY3437943 were evaluated in the trial: 1, 4, 8, and 12 milligrams (mg). Dose escalation to improve gastrointestinal (GI) tolerability occured in certain treatment groups up to Week 12 by increasing the volume of administered study drug (or placebo) during the 48-week double-blind, placebo-controlled treatment period.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).
FG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
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
Aug 29, 2022
May 17, 2023
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
Experimental
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
Drug: LY3437943
12 mg LY3437943 (2 mg)
Experimental
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Drug: LY3437943
8 mg LY3437943 (2 mg)
8 mg LY3437943 (4 mg)
Placebo
Drug
Administered SC
Placebo
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kilograms per square meter (kg/m2), ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
Week 24
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
Week 48
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
Week 24
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
Week 48
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
Week 24
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
Week 48
Mean Change From Baseline in Body Weight
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
Baseline, Week 24
Mean Change From Baseline in Body Weight
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
Baseline, Week 48
Mean Change From Baseline in BMI
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
Baseline, Week 24
Mean Change From Baseline in BMI
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
Baseline, Week 48
Mean Change From Baseline in Waist Circumference
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
Baseline, Week 24
Mean Change From Baseline in Waist Circumference
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
Jastreboff AM, Kaplan LM, Frias JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML; Retatrutide Phase 2 Obesity Trial Investigators. Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. N Engl J Med. 2023 Aug 10;389(6):514-526. doi: 10.1056/NEJMoa2301972. Epub 2023 Jun 26.
FG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
FG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
FG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
FG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
FG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
FG00070 subjects
FG00169 subjects
FG00233 subjects
FG00334 subjects
FG00435 subjects
FG00535 subjects
FG00662 subjects
Received at Least One Dose of Study Drug
FG00070 subjects
FG00169 subjects
FG00233 subjects
FG00333 subjects
FG00435 subjects
FG00535 subjects
FG00662 subjects
COMPLETED
FG00050 subjects
FG00160 subjects
FG00226 subjects
FG00326 subjects
FG00430 subjects
FG00529 subjects
FG00654 subjects
NOT COMPLETED
FG00020 subjects
FG0019 subjects
FG0027 subjects
FG0038 subjects
FG0045 subjects
FG0056 subjects
FG0068 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0062 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0005 subjects
FG0017 subjects
FG0025 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG00013 subjects
FG0011 subjects
FG0021 subjects
FG0034 subjects
FG004
Randomized but Never Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Inadvertent Enrollment
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Site Closure
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
BG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
BG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
BG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
BG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
BG005
8 mg LY343794 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
BG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00070
BG00169
BG00233
BG00334
BG00435
BG00535
BG00662
BG007338
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00048.00± 12.54
BG00150.60± 13.30
BG00250.80± 11.88
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00034
BG00133
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00022
BG00123
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00070
BG00169
BG002
Baseline Body Weight
Mean
Standard Deviation
kilograms (kg)
Title
Denominators
Categories
Title
Measurements
BG000109.21± 20.88
BG001106.36± 19.84
BG002
Baseline Body Mass Index (BMI)
Mean
Standard Deviation
kilograms per meter squared (kg/m^2)
Title
Denominators
Categories
Title
Measurements
BG00037.31± 5.90
BG00137.49± 5.85
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Percent Change From Baseline in Body Weight
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
All randomized participants who had baseline and at least one post-baseline body weight value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.55± 0.54
OG001-7.18± 0.67
OG002-12.00± 0.71
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
OG001
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-5.64
2-Sided
95
-7.34
-3.94
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
Secondary
Mean Percent Change From Baseline in Body Weight
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
All randomized participants who had baseline and at least one post-baseline body weight value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 48
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
Secondary
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kilograms per square meter (kg/m2), ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
All randomized participants who had baseline and at least one post-baseline value for ≥ 5% body weight reduction excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
Secondary
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
All randomized participants who had baseline and at least one post-baseline value for ≥ 5% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
Secondary
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
All randomized participants who had baseline and at least one post-baseline value for ≥ 10% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
Secondary
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
All randomized participants who had baseline and at least one post-baseline value for ≥ 10% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
Secondary
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
All randomized participants who had baseline and at least one post-baseline value for ≥ 15% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
Secondary
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<36 kg/m2, ≥36 kg/m2] and sex [female, male] as fixed effects, and baseline body weight as a covariate.
All randomized participants who had baseline and at least one post-baseline value for ≥ 15% body weight reduction, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Number
percentage of participants
Week 48
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
Secondary
Mean Change From Baseline in Body Weight
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
All randomized participants who had baseline and at least one post-baseline value for body weight, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Least Squares Mean
Standard Error
kilograms (kg)
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
Secondary
Mean Change From Baseline in Body Weight
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
All randomized participants who had baseline and at least one post-baseline value for body weight, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 48
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
Secondary
Mean Change From Baseline in BMI
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
All randomized participants who had baseline and at least one post-baseline BMI value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Least Squares Mean
Standard Error
kg/m^2
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
Secondary
Mean Change From Baseline in BMI
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
All randomized participants who had baseline and at least one post-baseline BMI value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Least Squares Mean
Standard Error
kg/m^2
Baseline, Week 48
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
Secondary
Mean Change From Baseline in Waist Circumference
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
All randomized participants who had baseline and at least one post-baseline waist circumference value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Least Squares Mean
Standard Error
centimeters (cm)
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
Secondary
Mean Change From Baseline in Waist Circumference
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment*Time + Baseline BMI (< 36kg/m2 vs. >=36 kg/m2)*Time + Sex (Female vs. Male)*Time + Baseline*Time.
All randomized participants who had baseline and at least one post-baseline waist circumference value, excluding participants discontinuing study drug due to inadvertent enrollment and data after discontinuation of study drug.
Posted
Least Squares Mean
Standard Error
cm
Baseline, Week 48
ID
Title
Description
OG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
OG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
OG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
OG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
Time Frame
Baseline Through End of Safety Follow-up (Up to 52 Weeks)
Description
All randomized participants who received at least one dose of study drug, regardless of adherence to study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received placebo matched to LY3437943 administered as SC injection QW.
0
70
3
70
40
70
EG001
1 mg LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
0
69
3
69
46
69
EG002
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
0
33
0
33
22
33
EG003
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
1
33
2
33
24
33
EG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY343794 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
0
35
1
35
26
35
EG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
0
35
2
35
31
35
EG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
0
62
2
62
52
62
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG0030 events0 affected33 at risk
EG0041 events1 affected35 at risk
EG0050 events0 affected35 at risk
EG0060 events0 affected62 at risk
Coronary artery stenosis
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Chest discomfort
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Drowning
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Covid-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Blood calcitonin increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected69 at risk
EG0020 events0 affected33 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG000-2.11± 0.73
OG001-8.67± 0.95
OG002-16.32± 1.58
OG003-17.83± 1.53
OG004-21.72± 1.41
OG005-23.88± 1.51
OG006-24.22± 1.24
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
OG001
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-6.57
2-Sided
95
-8.94
-4.20
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-14.21
2-Sided
95
-17.64
-10.78
Superiority
OG000
OG003
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-15.72
2-Sided
95
-19.05
-12.40
Superiority
OG000
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-19.62
2-Sided
95
-22.73
-16.51
Superiority
OG000
OG005
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-21.78
2-Sided
95
-25.05
-18.51
Superiority
OG000
OG006
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-22.11
2-Sided
95
-24.92
-19.31
Superiority
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG00026
OG00159
OG00287
OG00394
OG004100
OG005100
OG00697
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
OG001
Regression, Logistic
<0.001
Risk Difference (RD)
33
2-Sided
95
17
49
Superiority
OG000
OG002
Regression, Logistic
<0.001
Risk Difference (RD)
61
2-Sided
95
45
77
Superiority
OG000
OG003
Regression, Logistic
<0.001
Risk Difference (RD)
68
2-Sided
95
54
81
Superiority
OG000
OG004
Regression, Logistic
<0.001
Risk Difference (RD)
74
2-Sided
95
63
85
Superiority
OG000
OG005
Regression, Logistic
<0.001
Risk Difference (RD)
74
2-Sided
95
63
85
Superiority
OG000
OG006
Regression, Logistic
<0.001
Risk Difference (RD)
71
2-Sided
95
59
82
Superiority
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG00027
OG00164
OG00287
OG00397
OG004100
OG005100
OG006100
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
OG001
Regression, Logistic
<0.001
Risk Difference (RD)
37
2-Sided
95
20
54
Superiority
OG000
OG002
Regression, Logistic
<0.001
Risk Difference (RD)
60
2-Sided
95
44
76
Superiority
OG000
OG003
Regression, Logistic
<0.001
Risk Difference (RD)
70
2-Sided
95
57
83
Superiority
OG000
OG004
Regression, Logistic
<0.001
Risk Difference (RD)
73
2-Sided
95
62
84
Superiority
OG000
OG005
Regression, Logistic
<0.001
Risk Difference (RD)
73
2-Sided
95
62
84
Superiority
OG000
OG006
Regression, Logistic
<0.001
Risk Difference (RD)
73
2-Sided
95
67
84
Superiority
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG0003
OG00125
OG00259
OG00372
OG00483
OG00594
OG00690
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
OG001
Regression, Logistic
<0.001
Risk Difference (RD)
22
2-Sided
95
11
33
Superiority
OG000
OG002
Regression, Logistic
<0.001
Risk Difference (RD)
56
2-Sided
95
38
73
Superiority
OG000
OG003
Regression, Logistic
<0.001
Risk Difference (RD)
69
2-Sided
95
53
85
Superiority
OG000
OG004
Regression, Logistic
<0.001
Risk Difference (RD)
80
2-Sided
95
66
93
Superiority
OG000
OG005
Regression, Logistic
<0.001
Risk Difference (RD)
91
2-Sided
95
83
100
Superiority
OG000
OG006
Regression, Logistic
<0.001
Risk Difference (RD)
87
2-Sided
95
78
96
Superiority
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG0009
OG00127
OG00273
OG00376
OG00490
OG00591
OG00693
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
OG001
Regression, Logistic
0.008
Risk Difference (RD)
18
2-Sided
95
5
31
Superiority
OG000
OG002
Regression, Logistic
<0.001
Risk Difference (RD)
64
2-Sided
95
48
81
Superiority
OG000
OG003
Regression, Logistic
<0.001
Risk Difference (RD)
67
2-Sided
95
51
84
Superiority
OG000
OG004
Regression, Logistic
<0.001
Risk Difference (RD)
81
2-Sided
95
69
94
Superiority
OG000
OG005
Regression, Logistic
<0.001
Risk Difference (RD)
82
2-Sided
95
71
94
Superiority
OG000
OG006
Regression, Logistic
<0.001
Risk Difference (RD)
84
2-Sided
95
74
94
Superiority
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG0001
OG00110
OG00229
OG00344
OG00451
OG00568
OG00670
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
OG001
Regression, Logistic
0.029
Risk Difference (RD)
9
2-Sided
95
1
17
Superiority
OG000
OG002
Regression, Logistic
<0.001
Risk Difference (RD)
27
2-Sided
95
11
43
Superiority
OG000
OG003
Regression, Logistic
<0.001
Risk Difference (RD)
43
2-Sided
95
26
60
Superiority
OG000
OG004
Regression, Logistic
<0.001
Risk Difference (RD)
49
2-Sided
95
33
66
Superiority
OG000
OG005
Regression, Logistic
<0.001
Risk Difference (RD)
67
2-Sided
95
51
83
Superiority
OG000
OG006
Regression, Logistic
<0.001
Risk Difference (RD)
68
2-Sided
95
56
80
Superiority
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG0002
OG00116
OG00255
OG00364
OG00473
OG00577
OG00683
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
OG001
Regression, Logistic
0.002
Risk Difference (RD)
15
2-Sided
95
6
24
Superiority
OG000
OG002
Regression, Logistic
<0.001
Risk Difference (RD)
53
2-Sided
95
36
70
Superiority
OG000
OG003
Regression, Logistic
<0.001
Risk Difference (RD)
63
2-Sided
95
47
79
Superiority
OG000
OG004
Regression, Logistic
<0.001
Risk Difference (RD)
71
2-Sided
95
55
87
Superiority
OG000
OG005
Regression, Logistic
<0.001
Risk Difference (RD)
75
2-Sided
95
62
89
Superiority
OG000
OG006
Regression, Logistic
<0.001
Risk Difference (RD)
82
2-Sided
95
71
92
Superiority
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG000-1.27± 0.63
OG001-7.72± 0.73
OG002-12.59± 0.81
OG003-14.79± 1.09
OG004-17.70± 0.79
OG005-19.75± 1.08
OG006-18.53± 0.71
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
OG001
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-6.46
2-Sided
95
-8.36
-4.56
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-11.32
2-Sided
95
-13.34
-9.30
Superiority
OG000
OG003
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-13.52
2-Sided
95
-15.99
-11.05
Superiority
OG000
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-16.43
2-Sided
95
-18.41
-14.45
Superiority
OG000
OG005
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-18.48
2-Sided
95
-20.93
-16.04
Superiority
OG000
OG006
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-17.26
2-Sided
95
-19.11
-15.40
Superiority
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG000-1.84± 0.83
OG001-9.37± 1.06
OG002-17.32± 1.78
OG003-19.13± 1.80
OG004-23.52± 1.61
OG005-25.88± 1.68
OG006-26.17± 1.33
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
OG001
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-7.53
2-Sided
95
-10.18
-4.88
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-15.48
2-Sided
95
-19.35
-11.60
Superiority
OG000
OG003
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-17.29
2-Sided
95
-21.19
-13.39
Superiority
OG000
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-21.69
2-Sided
95
-25.25
-18.12
Superiority
OG000
OG005
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-24.04
2-Sided
95
-27.72
-20.36
Superiority
OG000
OG006
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-24.34
2-Sided
95
-27.40
-21.27
Superiority
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG000-0.49± 0.21
OG001-2.64± 0.26
OG002-4.47± 0.28
OG003-5.13± 0.36
OG004-6.15± 0.27
OG005-6.84± 0.36
OG006-6.44± 0.25
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
OG001
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-2.15
2-Sided
95
-2.80
-1.50
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-3.98
2-Sided
95
-4.66
-3.29
Superiority
OG000
OG003
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-4.64
2-Sided
95
-5.46
-3.82
Superiority
OG000
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-5.66
2-Sided
95
-6.34
-4.99
Superiority
OG000
OG005
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-6.35
2-Sided
95
-7.17
-5.53
Superiority
OG000
OG006
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-5.95
2-Sided
95
-6.59
-5.32
Superiority
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00068
OG00169
OG00233
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG000-0.72± 0.29
OG001-3.22± 0.37
OG002-6.14± 0.65
OG003-6.67± 0.59
OG004-8.12± 0.55
OG005-9.02± 0.57
OG006-9.14± 0.46
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
OG001
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-2.50
2-Sided
95
-3.42
-1.57
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-5.42
2-Sided
95
-6.81
-4.03
Superiority
OG000
OG003
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-5.95
2-Sided
95
-7.23
-4.67
Superiority
OG000
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-7.40
2-Sided
95
-8.62
-6.18
Superiority
OG000
OG005
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-8.30
2-Sided
95
-9.55
-7.05
Superiority
OG000
OG006
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-8.42
2-Sided
95
-9.49
-7.35
Superiority
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Units
Counts
Participants
OG00067
OG00169
OG00232
OG00333
OG00435
OG00535
OG00662
Title
Denominators
Categories
Title
Measurements
OG000-2.60± 0.80
OG001-5.43± 0.94
OG002-10.33± 1.05
OG003-12.55± 1.00
OG004-13.74± 1.04
OG005-14.99± 0.98
OG006-14.33± 0.86
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
OG001
Mixed Models Analysis
0.022
LS Mean difference (Final Values)
-2.82
2-Sided
95
-5.23
-0.41
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-7.73
2-Sided
95
-10.32
-5.13
Superiority
OG000
OG003
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-9.95
2-Sided
95
-12.47
-7.43
Superiority
OG000
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-11.14
2-Sided
95
-13.72
-8.56
Superiority
OG000
OG005
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-12.38
2-Sided
95
-14.87
-9.90
Superiority
OG000
OG006
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-11.73
2-Sided
95
-14.04
-9.43
Superiority
OG004
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
OG005
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
OG006
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.