Status:
RECRUITING
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight ma...
Eligibility Criteria
Inclusion
- Have a body mass index (BMI)
- ≥30 kilogram/square meter (kg/m²), or
- ≥27 kg/m² and \<30 kg/m², or with at least 1 weight-related comorbidity
- Have had a stable body weight for the 3 months prior to randomization (\<5%) body weight gain and/or loss.
Exclusion
- 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.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
1217 Patients enrolled
Trial Details
Trial ID
NCT06143956
Start Date
November 17 2023
End Date
September 1 2026
Last Update
December 23 2025
Active Locations (54)
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1
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States, 85225
2
HOPE Research Institute
Phoenix, Arizona, United States, 85032
3
Headlands Research - Scottsdale
Scottsdale, Arizona, United States, 85260
4
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, United States, 85712