NCT06993792

A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).

Conditions

• Obesity
• Overweight
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Orforglipron	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2025-05-15
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-05-29
• Last updated: 2026-04-16

Locations

80 sites across 7 countries: United States, Argentina, China, Czechia, Germany, Japan, Puerto Rico

Regulatory

• FDA-regulated drug study