NCT06649045

A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.

Conditions

• OSA
• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	Orforglipron	Administered orally.
DRUG	Placebo	Administered orally.

Timeline

• Start date: 2024-10-22
• Primary completion: 2026-11-01
• Completion: 2027-01-01
• First posted: 2024-10-18
• Last updated: 2025-09-29

Locations

66 sites across 9 countries: United States, Argentina, Brazil, China, Czechia, Germany, Japan, Mexico, Taiwan

Regulatory

• FDA-regulated drug study