A Chronic Weight Management Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

• Status: Recruiting
• Trial end date: 2025-09-05
• Target enrollment: 0
• Participant gender: All

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 management with intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

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

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Have a Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²)

• Have a BMI ≥27 kg/m²and <30 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 I 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:

• 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.