NCT06143956

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

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,217 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	LY3305677	Administered SC. ISA specific interventions will be listed in the ISA.
DRUG	LY3841136	Administered SC. ISA specific interventions will be listed in the ISA.
DRUG	Tirzepatide	Administered SC. ISA specific interventions will be listed in the ISA.
DRUG	Placebo	Administered SC. ISA specific interventions will be listed in the ISA.
DRUG	LY3549492	Administered orally. ISA specific interventions will be listed in the ISA.

Timeline

• Start date: 2023-11-17
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2023-11-22
• Last updated: 2026-04-06

Locations

54 sites across 2 countries: United States, Argentina

Regulatory

• FDA-regulated drug study