Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
Summary
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.
Timeline
- Start
- 2022-06-21
- Primary completion
- 2024-03-12
- Completion
- 2024-03-29
Outcome
Met primary endpoint
registry analysis (superiority test); Tirzepatide MTD_GPI1 vs Placebo_GPI1; p <0.001; LS Mean Change difference -20.01 (95% CI -25.82 to -14.20); ANCOVA NCT05412004 ↗
registry analysis (superiority test); Tirzepatide MTD_GPI2 vs Placebo_GPI2; p <0.001; LS Mean Change difference -23.77 (95% CI -29.61 to -17.93); ANCOVA NCT05412004 ↗
release “SURMOUNT-OSA phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo, achieving the primary endpoints.” lilly.com ↗
Publications
- Shinde S, Kanu C, Varnado OJ, Bednarik J, Dennehy EB, Dias-Barbosa C, Taylor N. Patients' Experiences of Obstructive Sleep Apnea and Tirzepatide Treatment: An Exit Interview Study. Patient. 2026 Jul;19(4):601-614. doi: 10.1007/s40271-026-00808-3. Epub 2026 Mar 7.
- Malhotra A, Grunstein R, Azarbarzin A, Sands S, Somers VK, Aronne LJ, Jastreboff AM, Lou J, Chakladar S, Dunn JP, Bunck MC, Bednarik J. Tirzepatide on obstructive sleep apnea-related cardiometabolic risk: secondary outcomes of the SURMOUNT-OSA randomized trial. Nat Med. 2026 Feb;32(2):653-659. doi: 10.1038/s41591-025-04071-1. Epub 2026 Jan 15.
- Malhotra A, Grunstein RR, Azarbarzin A, Sands SA, Dang X, Chakladar S, Dunn JP, Falcon B, Bednarik J. Tirzepatide for sleep-disordered breathing in SURMOUNT-OSA: Time course and association with body weight. Sleep Med. 2025 Dec;136:106853. doi: 10.1016/j.sleep.2025.106853. Epub 2025 Oct 14.
- Kanu C, Shinde S, Chakladar S, Dennehy EB, Weaver TE, Poon JL, Malhotra A. Effect of tirzepatide treatment on patient-reported outcomes among SURMOUNT-OSA participants with obstructive sleep apnea and obesity. Sleep Med. 2025 Oct;134:106719. doi: 10.1016/j.sleep.2025.106719. Epub 2025 Aug 6.
- Malhotra A, Grunstein RR, Fietze I, Weaver TE, Redline S, Azarbarzin A, Sands SA, Schwab RJ, Dunn JP, Chakladar S, Bunck MC, Bednarik J; SURMOUNT-OSA Investigators. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. N Engl J Med. 2024 Oct 3;391(13):1193-1205. doi: 10.1056/NEJMoa2404881. Epub 2024 Jun 21.
- Malhotra A, Bednarik J, Chakladar S, Dunn JP, Weaver T, Grunstein R, Fietze I, Redline S, Azarbarzin A, Sands SA, Schwab RJ, Bunck MC. Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial. Contemp Clin Trials. 2024 Jun;141:107516. doi: 10.1016/j.cct.2024.107516. Epub 2024 Mar 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tirzepatide | Peptide | 10 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 15 mg | Subcutaneous |