A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight
- Registration Number
- NCT06683508
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of LY3549492 in adults with obesity or overweight. Participation in the study will last about one year.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 275
W8M-MC-GN01:
- Assigned male at birth
- Assigned female at birth, who are of non-childbearing potential
W8M-MC-CWMM:
-
Have a BMI of
- ≥ 30 kilograms per square meter (kg/m²) or
- ≥ 27 kg/m² and < 30 kg/m² with at least one weight-related comorbidity
-
Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)
W8M-MC-GN01:
- Have Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus
- Have a history of acute or chronic pancreatitis
- Have renal impairment
- Individuals who are of childbearing potential
W8M-MC-CWMM:
-
Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.
-
Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
-
Have poorly controlled hypertension.
-
Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
-
Have any of the following cardiovascular conditions within 3 months prior to screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- unstable angina, or
- hospitalization due to congestive heart failure.
-
Have a history of symptomatic gallbladder disease within the past 2 years
-
Have a lifetime history of suicide attempts.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3549492 Dose 2 LY3549492 Participants will receive LY3549492 orally LY3549492 Dose 3 LY3549492 Participants will receive LY3549492 orally LY3549492 Dose 4 LY3549492 Participants will receive LY3549492 orally LY3549492 Dose 1 LY3549492 Participants will receive LY3549492 orally Placebo Placebo Participants will receive Placebo orally LY3549492 Dose 5 LY3549492 Participants will receive LY3549492 orally
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 36
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Weight (kilograms) Baseline, Week 36 Percentage of Participants who Achieve ≥5% Body Weight Reduction Baseline, Week 36 Percentage of Participants who Achieve ≥10% Body Weight Reduction Baseline, Week 36 Change from Baseline in Body Mass Index (BMI) Baseline, Week 36 Pharmacokinetics (PK): Average Concentration of LY3549492 Week 36
Trial Locations
- Locations (49)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, Arizona, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Headlands Research - Scottsdale
🇺🇸Scottsdale, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
🇺🇸Tucson, Arizona, United States
NorCal Medical Research, Inc
🇺🇸Greenbrae, California, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
Northeast Research Institute (NERI)
🇺🇸Fleming Island, Florida, United States
Scroll for more (39 remaining)The Institute for Liver Health II dba Arizona Clinical Trials - Mesa🇺🇸Chandler, Arizona, United States