Actively Recruiting
A Master Protocol for a Randomized, Controlled Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight
Led by Eli Lilly and Company · Updated on 2026-05-14
1481
Participants Needed
53
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 2 clinical trial to evaluate the safety and effectiveness of several investigational treatments for chronic weight management in adults with obesity or overweight. This master protocol study includes multiple intervention-specific appendices ISAs that allow for independent assessment of each treatment as they become available. The study aims to establish entry criteria and report results after all ISAs are completed. Participants will be randomly assigned to receive one of several treatments or a placebo. These treatments include LY3305677, LY3841136, tirzepatide, LY3549492, LY3532226, macupatide, and eloralintide, administered either by subcutaneous injection or orally, depending on the specific ISA. Each ISA provides detailed analysis of its respective intervention. During the study, participants will be monitored from baseline through week 6 to assess how many are allocated to each ISA. The trial uses a double-blind design to ensure unbiased results. Participants will be assessed regularly throughout their involvement, which lasts until the completion of all ISAs. Safety and efficacy data will be collected and analyzed throughout the trial.
CONDITIONS
Brief Title
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Have a body mass index (BMI) of 30 kg/m² or higher
- Or have a BMI between 27 and less than 30 kg/m² with at least one weight-related health condition
- Have had a stable body weight (less than 5% change) for the past 3 months
You will not qualify if you...
- Prior or planned surgical treatment for obesity, except liposuction or abdominoplasty performed more than 1 year before screening
- Type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of diabetic ketoacidosis or hyperosmolar coma
- Poorly controlled high blood pressure
- Signs or symptoms of liver disease other than nonalcoholic fatty liver disease
- Recent cardiovascular events within 3 months before screening, including heart attack, stroke, unstable angina, or heart failure hospitalization
- History of symptomatic gallbladder disease within the past 2 years
- Lifetime history of suicide attempts
Research Team
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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