A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
Purpose
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.
Conditions
- Obesity
- Overweight and Obesity
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
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)
Exclusion Criteria
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental LY3305677 Dose 1 |
Participants will receive LY3305677 subcutaneously (SC). |
|
Experimental LY3305677 Dose 2 |
Participants will receive LY3305677 SC. |
|
Experimental LY3305677 Dose 3 |
Participants will receive LY3305677 SC. |
|
Placebo Comparator Placebo |
Participants will receive LY3305677 matching placebo. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06124807
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company