A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
- Registration Number
- NCT06124807
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study, performed under a master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3305677 compared with placebo and in adult participants with obesity or overweight. The study will last about 62 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
W8M-MC-OXA1:
- Are males and females who agree to abide by the reproductive and contraceptive requirements
W8M-MC-CWMM:
- Have a BMI ≥27 kilograms per square meter (kg/m²)
W8M-MC-OXA1:
-
Have any prior diagnosis of diabetes mellitus, that is type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus, except gestational diabetes.
-
Have any of the following cardiovascular conditions within 6 months prior to screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- unstable angina, or
- hospitalization due to congestive heart failure (CHF).
-
Have a history of acute or chronic pancreatitis.
- Have a history of New York Heart Association (NYHA) Functional Classification I-IV CHF.
- Participants with hypertension who do not have well-controlled blood pressure (BP) (>140/90 mmHg), regardless of antihypertensive treatment. Participants receiving treatment for hypertension should be on a stable antihypertensive regimen for at least 3 months prior to screening.
Note: If the investigator anticipates a need to add antihypertensive medication during the study, the participant should not be included in the ambulatory blood pressure monitoring (ABPM) procedures.
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 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 LY3305677 Dose 3 LY3305677 Participants will receive LY3305677 SC. LY3305677 Dose 1 LY3305677 Participants will receive LY3305677 subcutaneously (SC). LY3305677 Dose 2 LY3305677 Participants will receive LY3305677 SC. Placebo Placebo Participants will receive LY3305677 matching placebo.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline to Week 32
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Weight Baseline, Week 48 Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3305677 Baseline to Week 56 Absolute Change from Baseline in Liver Fat Content by MRI-PDFF in Participants with Baseline LFC ≥5% and Baseline LFC≥10% Baseline to Week 48 Percent Change from Baseline in Body Weight Baseline, Week 48 PK: Maximum Concentration (Cmax) of LY3305677 Baseline to Week 56 Percentage of Participants Who Achieve ≥5% Body Weight Reduction Baseline to Week 48 Percentage of Participants Who Achieve ≥10% Body Weight Reduction Baseline to Week 48 Change from Baseline in Body Mass Index (BMI) Baseline to Week 32 Number of Participants with Treatment Emergent Drug Antibodies (TE-ADAs) Baseline to Week 56 Absolute Change from Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) in Participants with Baseline LFC≥5% and Baseline LFC≥10% Baseline to Week 32 Percent Change from Baseline in Liver Fat Content by MRI-PDFF in Participants with Baseline LFC≥5% and Baseline LFC≥10% Baseline to Week 32 Percentage of Participants Who Achieve ≥30% Relative Reduction in LFC Baseline to Week 32 Percentage of Participants Who Achieve >30% Relative Reduction in LFC Baseline to Week 48 Percent Change from Baseline in Liver Fat Content by MRI-PDFF in Participants with Baseline LFC ≥5% and Baseline LFC≥10% Baseline, Week 48 Change from Baseline in BMI Baseline to Week 48
Trial Locations
- Locations (29)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, 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
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
Northeast Research Institute (NERI)
🇺🇸Fleming Island, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Charter Research - Winter Park
🇺🇸Orlando, Florida, United States
Charter Research - Lady Lake
🇺🇸The Villages, Florida, United States
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