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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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 CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

Key facts

Study ID

NCT06143956

Run by

Eli Lilly and Company

People needed

1481

Starts

2023-11-17

Expected to finish

2028-02-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinvest Headlands Llc — Springfield, Missouri, United States (enrolling)
• Headlands Research - Scottsdale — Scottsdale, Arizona, United States (enrolling)
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States (enrolling)
• StudyMetrix Research — City of Saint Peters, Missouri, United States (enrolling)
• Velocity Clinical Research, Huntington Park — Huntington Park, California, United States (enrolling)
• Peninsula Research Associates — Rolling Hills Estates, California, United States (enrolling)
• The Institute for Liver Health II dba Arizona Liver Health-Tucson — Tucson, Arizona, United States (enrolling)
• Headlands Research - Detroit — Southfield, Michigan, United States (enrolling)
• The Institute for Liver Health II dba Arizona Clinical Trials - Mesa — Chandler, Arizona, United States (enrolling)
• New Horizon Research Center — Miami, Florida, United States (enrolling)
• Indago Research & Health Center, Inc — Miami Lakes, Florida, United States (enrolling)
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States (enrolling)
• Charter Research - Winter Park — Orlando, Florida, United States (enrolling)
• Charter Research - Lady Lake — The Villages, Florida, United States (enrolling)
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States (enrolling)
• Medical Research Partners — Ammon, Idaho, United States (enrolling)
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States (enrolling)
• Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States (enrolling)
• NorCal Medical Research, Inc — Greenbrae, California, United States (enrolling)
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States (enrolling)
• Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States (enrolling)
• Monroe Biomedical Research - Louisville — Louisville, Kentucky, United States (enrolling)
• Knownwell — Needham, Massachusetts, United States (enrolling)
• Lucida Clinical Trials — New Bedford, Massachusetts, United States (enrolling)
• Las Vegas Medical Research — Las Vegas, Nevada, United States (enrolling)

Full record on ClinicalTrials.gov

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