Back to resultsA Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
Primary Purpose
Obesity, Overweight and Obesity
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3502970
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
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
Sites / Locations
- Anaheim Clinical Trials, LLC
- John Muir Physician Network Research Center
- NorCal Medical Research, Inc
- Valley Clinical Trials, Inc.
- Norcal Endocrinology & Internal Medicine
- Elite Clinical Trials
- Rocky Mountain Clinical Research
- StudyMetrix Research
- Premier Research
- Lillestol Research
- Intend Research, LLC
- Capital Area Research, LLC
- Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
- Dallas Diabetes Research Center
- Diabetes and Thyroid Center of Fort Worth
- Texas Diabetes & Endocrinology, P.A.
- National Clinical Research, Inc
- St. Vincent Hospital d/b/a Prevea Health
- C-health Research
- Wharton Medical Clinic
- Bluewater Clinical Research Group Inc.
- Centre Médical et Professionnel de l'Ouest de Portneuf
- Alpha Recherche Clinique
- ALPHA Recherche Clinique
- Studium Egeszseghaz Kft
- Bugát Pál Kórház
- DRC Gyógyszervizsgáló Központ
- Kanizsai Dorottya Korhaz
- Szent Margit Rendelőintézet Nonprofit Kft
- Clinexpert Kft.
- TRANTOR'99 Bt. Anyagcsere Centrum
- Strazsahegy Medicina Bt.
- Debreceni Egyetem Klinikai Kozpont
- Puerto Rico Medical Research
- Research and Cardiovascular Corp.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
12 milligram (mg) LY3502970
24 mg LY3502970
36 mg-1 LY3502970
36 mg-2 LY3502970
45 mg-1 LY3502970
45 mg-2 LY3502970
Placebo
Arm Description
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.
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.
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.
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.
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.
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.
Participants received placebo administered orally once daily until 36 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with >=5% body weight loss was reported.
Percentage of Participants With >=10% Body Weight Loss
Percentage of participants with >=10% body weight loss was reported.
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with >=5% body weight loss was reported.
Percentage of Participants With >=10% Body Weight Loss
Percentage of participants with >=10% body weight loss was reported.
Full Information
NCT ID
NCT05051579
First Posted
September 17, 2021
Last Updated
August 23, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05051579
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
November 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12 milligram (mg) LY3502970
Arm Type
Experimental
Arm Description
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.
Arm Title
24 mg LY3502970
Arm Type
Experimental
Arm Description
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.
Arm Title
36 mg-1 LY3502970
Arm Type
Experimental
Arm Description
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.
Arm Title
36 mg-2 LY3502970
Arm Type
Experimental
Arm Description
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.
Arm Title
45 mg-1 LY3502970
Arm Type
Experimental
Arm Description
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.
Arm Title
45 mg-2 LY3502970
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo administered orally once daily until 36 weeks.
Intervention Type
Drug
Intervention Name(s)
LY3502970
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Description
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.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Description
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.
Time Frame
Baseline, Week 36
Title
Change From Baseline in Body Weight in LY3502970 and Placebo
Description
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.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Body Weight in LY3502970 and Placebo
Description
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.
Time Frame
Baseline, Week 36
Title
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Description
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.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Description
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.
Time Frame
Baseline, Week 36
Title
Change From Baseline in BMI in LY3502970 and Placebo
Description
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.
Time Frame
Baseline, Week 26
Title
Change From Baseline in BMI in LY3502970 and Placebo
Description
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.
Time Frame
Baseline, Week 36
Title
Percentage of Participants With >=5% Body Weight Loss
Description
Percentage of participants with >=5% body weight loss was reported.
Time Frame
Week 26
Title
Percentage of Participants With >=10% Body Weight Loss
Description
Percentage of participants with >=10% body weight loss was reported.
Time Frame
Week 26
Title
Percentage of Participants With >=5% Body Weight Loss
Description
Percentage of participants with >=5% body weight loss was reported.
Time Frame
Week 36
Title
Percentage of Participants With >=10% Body Weight Loss
Description
Percentage of participants with >=10% body weight loss was reported.
Time Frame
Week 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
John Muir Physician Network Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
NorCal Medical Research, Inc
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Norcal Endocrinology & Internal Medicine
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Elite Clinical Trials
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Intend Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Capital Area Research, LLC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Diabetes and Thyroid Center of Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
National Clinical Research, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
St. Vincent Hospital d/b/a Prevea Health
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
C-health Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4J2
Country
Canada
Facility Name
Wharton Medical Clinic
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Bluewater Clinical Research Group Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Centre Médical et Professionnel de l'Ouest de Portneuf
City
Saint Marc des Carrières
State/Province
Quebec
ZIP/Postal Code
G0A 4B0
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Facility Name
ALPHA Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Studium Egeszseghaz Kft
City
Kalocsa
State/Province
Bács-Kiskun
ZIP/Postal Code
6300
Country
Hungary
Facility Name
Bugát Pál Kórház
City
Gyongyos
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
DRC Gyógyszervizsgáló Központ
City
Balatonfüred
State/Province
Veszprém
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Kanizsai Dorottya Korhaz
City
Nagykanizsa
State/Province
Zala
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Szent Margit Rendelőintézet Nonprofit Kft
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Clinexpert Kft.
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
TRANTOR'99 Bt. Anyagcsere Centrum
City
Budapest
ZIP/Postal Code
1213
Country
Hungary
Facility Name
Strazsahegy Medicina Bt.
City
Budapest
ZIP/Postal Code
H1171
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Puerto Rico Medical Research
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Research and Cardiovascular Corp.
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/1R7BP1Yw5t6roV3ZWFGzYQ
Description
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
Learn more about this trial
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
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