A Study of LY3502970 in Participants With Obesity or Over... | NCT05051579 | Trialant
NCT05051579
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 13, 2023Actual
Enrollment
272Actual
Phase
Phase 2
Conditions
Obesity
Overweight and Obesity
Interventions
LY3502970
Placebo
Countries
United States
Canada
Hungary
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT05051579
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
18210
Secondary IDs
ID
Type
Description
Link
J2A-MC-GZGI
Other Identifier
Eli Lilly and Company
2021-002805-88
EudraCT Number
Brief Title
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
Official Title
A Phase 2 Study of Once-Daily LY3502970 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
Sep 29, 2021Actual
Primary Completion Date
Aug 25, 2022Actual
Completion Date
Nov 22, 2022Actual
First Submitted Date
Sep 17, 2021
First Submission Date that Met QC Criteria
Sep 17, 2021
First Posted Date
Sep 21, 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
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
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
The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
Detailed Description
Not provided
Conditions Module
Conditions
Obesity
Overweight and 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
272Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
12 milligram (mg) LY3502970
Experimental
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
Drug: LY3502970
24 mg LY3502970
Experimental
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
Drug: LY3502970
36 mg-1 LY3502970
Experimental
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
Drug: LY3502970
36 mg-2 LY3502970
Experimental
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
Drug: LY3502970
45 mg-1 LY3502970
Experimental
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3502970
Drug
Administered orally
12 milligram (mg) LY3502970
24 mg LY3502970
36 mg-1 LY3502970
36 mg-2 LY3502970
45 mg-1 LY3502970
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 26
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 36
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²)
Have a BMI ≥27 kg/m² and <30 kg/m² with at least 1 of the following weight-related comorbidities eg; [Have hypertension, or dyslipidemia, cardiovascular disease]
Have had a stable body weight for the 3 months prior to randomization (not more than 5% body weight gain and/or loss)
Exclusion Criteria:
Have any prior diagnosis of diabetes
Have a prior or planned surgical treatment for obesity
Have obesity induced by other endocrinological disorders or diagnosed monogenetic or syndromic forms of obesity
Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 milliliter (mL)/minute (min)/1.73 m²
Have a history of acute chronic pancreatitis
Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, may be considered for inclusion if they are not on excluded medications.
Within 3 months prior to screening:
Have poorly controlled hypertension
Have history of acute myocardial infarction
Have history of cerebrovascular accident (stroke)
Had hospitalization due to congestive heart failure (CHF)
Have cancer
Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
Have hepatitis B and/or positive hepatitis B surface antigen
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 1-317-5615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Wharton S, Rosenstock J, Konige M, Lin Y, Duffin K, Wilson J, Banerjee H, Pirro V, Kazda C, Mather K. Treatment with orforglipron, an oral glucagon like peptide-1 receptor agonist, is associated with improvements of CV risk biomarkers in participants with type 2 diabetes or obesity without diabetes. Cardiovasc Diabetol. 2025 Jun 6;24(1):240. doi: 10.1186/s12933-025-02781-x.
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.
For maintenance doses of LY3502970: 12, 24, 36, and 45 milligram (mg), the initial dose will be 2 or 3 mg followed by additional escalation steps as appropriate. The dose-escalation varied by dose group where the target maintenance dose was achieved between Weeks 5 and 16.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
FG001
24 mg LY3502970
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
Sep 27, 2021
Aug 8, 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
Drug: LY3502970
45 mg-2 LY3502970
Experimental
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
Drug: LY3502970
Placebo
Placebo Comparator
Participants received placebo administered orally once daily until 36 weeks.
Drug: Placebo
45 mg-2 LY3502970
Placebo
Drug
Administered orally
Placebo
Change From Baseline in Body Weight in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 26
Change From Baseline in Body Weight in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 36
Change From Baseline in Waist Circumference in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 26
Change From Baseline in Waist Circumference in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 36
Change From Baseline in BMI in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 26
Change From Baseline in BMI in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 36
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with >=5% body weight loss was reported.
Week 26
Percentage of Participants With >=10% Body Weight Loss
Percentage of participants with >=10% body weight loss was reported.
Week 26
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with >=5% body weight loss was reported.
Week 36
Percentage of Participants With >=10% Body Weight Loss
Percentage of participants with >=10% body weight loss was reported.
Week 36
Concord
California
94520
United States
NorCal Medical Research, Inc
Greenbrae
California
94904
United States
Valley Clinical Trials, Inc.
Northridge
California
91325
United States
Norcal Endocrinology & Internal Medicine
San Ramon
California
94583
United States
Elite Clinical Trials
Blackfoot
Idaho
83221
United States
Rocky Mountain Clinical Research
Idaho Falls
Idaho
83404
United States
StudyMetrix Research
City of Saint Peters
Missouri
63303
United States
Premier Research
Trenton
New Jersey
08611
United States
Lillestol Research
Fargo
North Dakota
58104
United States
Intend Research, LLC
Norman
Oklahoma
73069
United States
Capital Area Research, LLC
Camp Hill
Pennsylvania
17011
United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Wharton S, Blevins T, Connery L, Rosenstock J, Raha S, Liu R, Ma X, Mather KJ, Haupt A, Robins D, Pratt E, Kazda C, Konig M; GZGI Investigators. Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. N Engl J Med. 2023 Sep 7;389(10):877-888. doi: 10.1056/NEJMoa2302392. Epub 2023 Jun 23.
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
FG002
36 mg -1 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
FG003
36 mg -2 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
FG004
45 mg -1 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
FG005
45 mg -2 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
FG006
Placebo
Participants received placebo administered orally once daily until 36 weeks.
FG00050 subjects
FG00153 subjects
FG00229 subjects
FG00329 subjects
FG00431 subjects
FG00530 subjects
FG00650 subjects
COMPLETED
FG00044 subjects
FG00146 subjects
FG00227 subjects
FG00324 subjects
FG00423 subjects
FG00528 subjects
FG00643 subjects
NOT COMPLETED
FG0006 subjects
FG0017 subjects
FG0022 subjects
FG0035 subjects
FG0048 subjects
FG0052 subjects
FG0067 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0003 subjects
FG0015 subjects
FG0022 subjects
FG0031 subjects
FG0044 subjects
FG0050 subjects
FG0064 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject Unable to Visit Due to Working Out of Town
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Adverse Event
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0034 subjects
FG004
Inadvertent Enrollment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject Could not Tolerate Investigational Product (IP) and was Taken Off
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Patient was Initially Long Term Follow-up But Contacted and came to Site After Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
BG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
BG002
36 mg -1 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
BG003
36 mg -2 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
BG004
45 mg -1 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
BG005
45 mg -2 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
BG006
Placebo
Participants received placebo administered orally once daily until 36 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00050
BG00153
BG00229
BG00329
BG00431
BG00530
BG00650
BG007272
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
BG00049.80± 10.51
BG00157.00± 9.09
BG00256.30± 11.83
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00031
BG00130
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00011
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
Title
Measurements
BG0009
BG00111
BG002
Baseline Body Weight
Mean
Standard Deviation
Kilograms (kg)
Title
Denominators
Categories
Title
Measurements
BG000107.49± 25.34
BG001112.05± 30.18
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
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 26
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
OG003
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00044
OG00151
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG000-8.6± 0.85
OG001-11.2± 0.82
OG002-12.3± 0.77
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
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-6.5
2-Sided
95
-8.9
-4.2
Superiority
OG001
OG004
Mixed Models Analysis
<0.001
Secondary
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 36
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
Secondary
Change From Baseline in Body Weight in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 26
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
Secondary
Change From Baseline in Body Weight in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.
Posted
Least Squares Mean
Standard Error
kg
Baseline, Week 36
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
Secondary
Change From Baseline in Waist Circumference in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body waist circumference value.
Posted
Least Squares Mean
Standard Error
centimeter (cm)
Baseline, Week 26
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
Secondary
Change From Baseline in Waist Circumference in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body waist circumference value.
Posted
Least Squares Mean
Standard Error
cm
Baseline, Week 36
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
Secondary
Change From Baseline in BMI in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value.
Posted
Least Squares Mean
Standard Error
kilograms per meter square (kg/m^2)
Baseline, Week 26
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
Secondary
Change From Baseline in BMI in LY3502970 and Placebo
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value.
Posted
Least Squares Mean
Standard Error
kg/m^2
Baseline, Week 36
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
Secondary
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with >=5% body weight loss was reported.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% body weight reduction.
Posted
Number
percentage of participants
Week 26
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
OG003
Secondary
Percentage of Participants With >=10% Body Weight Loss
Percentage of participants with >=10% body weight loss was reported.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% body weight reduction.
Posted
Number
percentage of participants
Week 26
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
OG003
Secondary
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with >=5% body weight loss was reported.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% body weight reduction.
Posted
Number
percentage of participants
Week 36
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
OG003
Secondary
Percentage of Participants With >=10% Body Weight Loss
Percentage of participants with >=10% body weight loss was reported.
All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% body weight reduction.
Posted
Number
percentage of participants
Week 36
ID
Title
Description
OG000
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
OG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
OG002
36 mg LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.
OG003
Time Frame
Baseline through Week 38 (36 weeks with 2 weeks safety follow up)
Description
All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
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
12 mg LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
0
50
0
50
35
50
EG001
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
0
53
2
53
46
53
EG002
36 Mg-1 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
0
29
0
29
23
29
EG003
36 Mg-2 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
0
29
3
29
25
29
EG004
45 Mg-1 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
0
31
2
31
26
31
EG005
45 Mg-2 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
0
30
0
30
24
30
EG006
Placebo
Participants received placebo administered orally once daily until 36 weeks.
0
50
0
50
27
50
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coronary artery disease
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected53 at risk
EG0020 events0 affected29 at risk
EG0030 events0 affected29 at risk
EG0041 events1 affected31 at risk
EG0050 events0 affected30 at risk
EG0060 events0 affected50 at risk
Retinal vein thrombosis
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected53 at risk
EG0020 events0 affected29 at risk
EG003
Vitreoretinal traction syndrome
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected53 at risk
EG0020 events0 affected29 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected53 at risk
EG0020 events0 affected29 at risk
EG003
Gastrointestinal polyp haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected53 at risk
EG0020 events0 affected29 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected53 at risk
EG0020 events0 affected29 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected53 at risk
EG0020 events0 affected29 at risk
EG003
Hepatic cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00044
OG00151
OG00256
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG000-9.4± 1.05
OG001-12.5± 1.01
OG002-13.5± 0.95
OG003-14.7± 0.94
OG004-2.3± 1.00
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
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-7.1
2-Sided
95
-9.9
-4.2
Other
OG001
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-10.1
2-Sided
95
-12.9
-7.3
Other
OG002
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-11.1
2-Sided
95
-13.8
-8.4
Other
OG003
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-12.3
2-Sided
95
-15.0
-9.6
Other
OG003
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00044
OG00151
OG00256
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG000-9.0± 0.90
OG001-12.3± 0.86
OG002-12.9± 0.82
OG003-13.3± 0.79
OG004-2.1± 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
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-6.9
2-Sided
95
-9.3
-4.4
Other
OG001
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-10.2
2-Sided
95
-12.5
-7.8
Other
OG002
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-10.8
2-Sided
95
-13.1
-8.5
Other
OG003
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-11.2
2-Sided
95
-13.5
-8.9
Other
OG003
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00044
OG00151
OG00256
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG000-9.8± 1.10
OG001-13.6± 1.06
OG002-14.2± 1.00
OG003-15.4± 0.98
OG004-2.4± 1.05
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
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-7.4
2-Sided
95
-10.4
-4.3
Other
OG001
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-11.2
2-Sided
95
-14.2
-8.3
Other
OG002
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-11.8
2-Sided
95
-14.7
-9.0
Other
OG003
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-13.0
2-Sided
95
-15.8
-10.2
Other
OG003
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00043
OG00149
OG00252
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG000-8.0± 1.03
OG001-8.8± 1.00
OG002-10.1± 0.94
OG003-12.2± 0.93
OG004-3.6± 0.99
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
OG004
Mixed Models Analysis
0.002
LS Mean difference (Final Values)
-4.4
2-Sided
95
-7.2
-1.6
Other
OG001
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-5.2
2-Sided
95
-8.0
-2.4
Other
OG002
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-6.5
2-Sided
95
-9.2
-3.8
Other
OG003
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-8.7
2-Sided
95
-11.3
-6.0
Other
OG003
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00043
OG00149
OG00252
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG000-9.6± 1.18
OG001-11.2± 1.15
OG002-10.6± 1.06
OG003-13.6± 1.07
OG004-4.0± 1.12
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
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-5.6
2-Sided
95
-8.8
-2.4
Other
OG001
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-7.2
2-Sided
95
-10.3
-4.0
Other
OG002
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-6.6
2-Sided
95
-9.7
-3.6
Other
OG003
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-9.6
2-Sided
95
-12.7
-6.6
Other
OG003
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00044
OG00151
OG00256
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG000-3.2± 0.31
OG001-4.2± 0.30
OG002-4.6± 0.28
OG003-4.7± 0.27
OG004-0.8± 0.29
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
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-2.4
2-Sided
95
-3.2
-1.6
Other
OG001
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-3.5
2-Sided
95
-4.3
-2.6
Other
OG002
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-3.8
2-Sided
95
-4.6
3.0
Other
OG003
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-3.9
2-Sided
95
-4.7
-3.1
Other
OG003
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00044
OG00151
OG00256
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG000-3.4± 0.38
OG001-4.7± 0.36
OG002-5.0± 0.34
OG003-5.5± 0.34
OG004-0.9± 0.36
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
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-2.5
2-Sided
95
-3.6
-1.5
Other
OG001
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-3.8
2-Sided
95
-4.8
-2.8
Other
OG002
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-4.2
2-Sided
95
-5.2
-3.2
Other
OG003
OG004
Mixed Models Analysis
<0.001
LS Mean difference (Final Values)
-4.6
2-Sided
95
-5.6
-3.6
Other
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00044
OG00151
OG00256
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG00074.39
OG00188.84
OG00289.46
OG00387.26
OG00422.88
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
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
9.96
2-Sided
95
3.61
27.44
Other
OG001
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
27.97
2-Sided
95
8.15
96.01
Other
OG002
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
27.36
2-Sided
95
8.71
85.91
Other
OG003
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
23.59
2-Sided
95
7.65
72.77
Other
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00044
OG00151
OG00256
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG00039.39
OG00156.61
OG00271.30
OG00369.86
OG0042.25
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
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
19.93
2-Sided
95
3.47
114.40
Other
OG001
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
39.52
2-Sided
95
6.95
224.83
Other
OG002
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
74.97
2-Sided
95
13.16
427.18
Other
OG003
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
72.23
2-Sided
95
12.62
413.21
Other
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.
Units
Counts
Participants
OG00044
OG00151
OG00256
OG00357
OG00448
Title
Denominators
Categories
Title
Measurements
OG00072.00
OG00189.47
OG00292.05
OG00390.44
OG00424.02
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
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
7.79
2-Sided
95
2.90
20.92
Other
OG001
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
25.07
2-Sided
95
7.49
83.91
Other
OG002
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
34.76
2-Sided
95
8.17
147.86
Other
OG003
OG004
Regression, Logistic
<0.001
Odds Ratio (OR)
28.01
2-Sided
95
8.15
96.29
Other
45 mg LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.
OG004
Placebo
Participants received placebo administered orally once daily until 36 weeks.