Phase 3 · 469 participants
SURMOUNT-OSA: A Study of Tirzepatide in Adults with Obesity and Moderate-to-Severe Obstructive Sleep Apnea
SURMOUNT-OSA was two parallel trials testing tirzepatide in adults with obesity + moderate-to-severe OSA (with and without CPAP). Led to FDA approval of Zepbound for OSA (December 2024) — the first weight-loss drug approved for…
Evidence summary
- Background
- SURMOUNT-OSA was two parallel trials testing tirzepatide in adults with obesity + moderate-to-severe OSA (with and without CPAP). Led to FDA approval of Zepbound for OSA (December 2024) — the first weight-loss drug approved for OSA. Major impact on Medicare coverage paths.
- Methods
- Phase 3, n=469, 52 weeks. Sponsor: Eli Lilly. Primary outcome: Change in apnea-hypopnea index (AHI) from baseline to week 52.
- Results
- −25 to −29 events/hour mean reduction on tirzepatide vs −5 events/hour placebo
- Conclusion
- First trial of a weight-loss drug in OSA as primary outcome.
Background + significance
SURMOUNT-OSA was two parallel trials testing tirzepatide in adults with obesity + moderate-to-severe OSA (with and without CPAP). Led to FDA approval of Zepbound for OSA (December 2024) — the first weight-loss drug approved for OSA. Major impact on Medicare coverage paths.
Trial design
- Sponsor
- Eli Lilly
- Phase
- Phase 3
- Participants
- 469
- Duration
- 52 weeks
- ClinicalTrials.gov ID
- NCT05412004 (opens in a new tab)
Drugs tested
Primary outcome
Change in apnea-hypopnea index (AHI) from baseline to week 52
−25 to −29 events/hour mean reduction on tirzepatide vs −5 events/hour placebo
Secondary outcomes
- Improvements in patient-reported sleep quality
- Reduced CPAP dependence in some patients
- Body-weight reduction 18-20%
Why it matters
- 1.First trial of a weight-loss drug in OSA as primary outcome.
- 2.FDA-approved indication added December 2024.
- 3.Opens Medicare coverage path for some Zepbound patients (OSA is a covered indication, weight management is not).
Publication
Tirzepatide for the Treatment of Obstructive Sleep Apnea + Obesity
NEJM, 2024 · DOI 10.1056/NEJMoa2404881
Read full paper (opens in a new tab)