Status:
COMPLETED
A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Overweight and Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2025
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT06124807
Start Date
November 17 2023
End Date
July 9 2025
Last Update
July 20 2025
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States, 85225
2
Headlands Research - Scottsdale
Scottsdale, Arizona, United States, 85260
3
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, United States, 85712
4
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States, 90255