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

NCT06649045 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing the investigational drug orforglipron in adults with obstructive sleep apnea who are also overweight or obese to see how it affects their sleep apnea symptoms.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 600 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2024-10 · est. completion 2027-01

Where 66 sites · Argentina, Brazil, China, Czechia, Germany, Japan, Mexico, Taiwan, United States

What this study is testing ClinicalTrials.gov NCT06649045 ↗

Description as written by the study sponsor.

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.

Treatments tested

Orforglipron also known as LY3502970 Drug

Administered orally.
Placebo Drug

Administered orally.

Main thing measured	Change from Baseline in Apnea-Hypopnea Index (AHI)
Sponsor	Eli Lilly and Company
Conditions studied	OSA, Overweight or Obesity
GLP-1 drugs	orforglipron

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06649045 ↗