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

Phase 2

Recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: LY3305677; Drug: LY3841136; Drug: Placebo; Drug: Tirzepatide; Drug: LY3549492

• Registration Number: NCT06143956
• Lead Sponsor: Eli Lilly and Company

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-06
• Study Start: 2023-11-17
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-22
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-21
• Primary Completion: 2026-09
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1217

Inclusion Criteria

• 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3305677 Obesity ISA OXA1	LY3305677	Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.
LY3305677 Obesity ISA OXA1	Placebo	Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.
LY3841136 Obesity ISA LAA1	LY3841136	Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.
LY3841136 Obesity ISA LAA1	Placebo	Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.
LY3841136 Obesity ISA LAA2	LY3841136	Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.
LY3841136 Obesity ISA LAA2	Tirzepatide	Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.
LY3841136 Obesity ISA LAA2	Placebo	Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.
LY3549492 Obesity ISA GN01	Placebo	Participants will receive LY3549492 orally. Each ISA will detail the intervention specific analysis.
LY3549492 Obesity ISA GN01	LY3549492	Participants will receive LY3549492 orally. Each ISA will detail the intervention specific analysis.
LY3549492 Obesity ISA GN02	Placebo	Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
LY3549492 Obesity ISA GN02	LY3549492	Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.

Primary Outcome Measures

Name	Time	Method
Number of Participants Allocated to Each ISA	Baseline to Week 48	Each ISA will detail the intervention specific analysis.

Trial Locations

Locations (54)

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa; 🇺🇸 Chandler, Arizona, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Headlands Research - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

The Institute for Liver Health II dba Arizona Liver Health-Tucson; 🇺🇸 Tucson, Arizona, United States

NorCal Medical Research, Inc; 🇺🇸 Greenbrae, California, United States

Velocity Clinical Research, Huntington Park; 🇺🇸 Huntington Park, California, United States

Peninsula Research Associates; 🇺🇸 Rolling Hills Estates, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Stamford Therapeutics Consortium; 🇺🇸 Stamford, Connecticut, United States

Northeast Research Institute (NERI); 🇺🇸 Fleming Island, Florida, United States

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