NCT06672549

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Detailed description

The PWMP 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. PWMP results will be reported when all the ISA's complete.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	Orforglipron	Administered orally. ISA specific interventions will be listed in the ISA.
DRUG	Placebo	Administered orally. ISA specific interventions will be listed in the ISA.

Timeline

• Start date: 2024-11-18
• Primary completion: 2027-02-01
• Completion: 2027-03-01
• First posted: 2024-11-04
• Last updated: 2026-03-24

Locations

41 sites across 7 countries: United States, Brazil, Israel, Italy, Mexico, Poland, United Kingdom

Regulatory

• FDA-regulated drug study