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

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.

Timeline

Start

2024-10-22

Primary completion

2026-11

Completion

2027-01

Publications

• Malhotra A, Gottlieb DJ, Kundel V, Woehrle H, Chakladar S, Firmino Goncalves L, Calamai G. Orforglipron for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity or overweight: Study design and baseline characteristics of ATTAIN-OSA, a phase 3 trial. Contemp Clin Trials Commun. 2026 Jun 19;52:101660. doi: 10.1016/j.conctc.2026.101660. eCollection 2026 Aug.

Drugs

Indications