A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

• Status: Recruiting
• Trial end date: 2025-05-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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) with at least one of the following weight-related comorbidities:

• hypertension: on blood pressure (BP)-lowering medication.

• dyslipidemia: on lipid-lowering medication

• cardiovascular (CV) disease: for example, ischemic CV disease, New York Heart Association (NYHA) Functional Classification Class 1 or II Heart Failure

• obstructive sleep apnea

• Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss).

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.

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.