SURMOUNT-OSA
Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.
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. · The New England journal of medicine
Study record
- Population
469 adults randomized with obesity and moderate-to-severe obstructive sleep apnea; diabetes excluded.
Read source · Full-text reportParticipants; Results — Participants, PDF pages 3, 6- Formulation
Tirzepatide or placebo in single-dose autoinjectors.
Read source · Full-text reportTrial Procedures, PDF page 3- Route
Subcutaneous.
Read source · Full-text reportTrial Procedures, PDF page 3- Dose & frequency
2.5 mg weekly initially; 2.5 mg increases every four weeks toward tolerated 10/15 mg.
Read source · Full-text reportTrial Procedures, PDF page 3- Study design
Two double-blind randomized trials: without PAP at baseline (234) and existing PAP users (235); lifestyle counseling accompanied both.
Read source · Full-text reportTrial Design; Results — Participants- Duration
52-week treatment; four-week safety follow-up.
Read source · Full-text reportTrial Procedures, PDF page 3- Reported findings
Treatment-regimen AHI differences versus placebo: −20.0 events/hour (95% CI −25.8 to −14.2) and −23.8 (−29.6 to −17.9), respectively.
Read source · Full-text reportTable 2, PDF page 8- Adverse events
Serious events: 9/114 versus 7/120 in trial 1; 7/119 versus 12/114 in trial 2. Two adjudicated pancreatitis cases occurred with tirzepatide in trial 2.
Read source · Full-text reportTable 4, PDF page 10- Monitoring
Polysomnography and adverse-event assessment; PAP paused seven days before selected assessments in trial 2.
Read source · Full-text reportEnd Points and Assessments, PDF page 3
What it supports
Assesses sleep-apnea severity in obesity.
What it does not establish
Not a head-to-head PAP comparison or instruction to stop PAP. Randomized and safety denominators differ.
Funding
Eli Lilly; sponsor participated in design and analysis.
Publication and registry context
Registry AHI differences agree with the publication after rounding: −20.01 and −23.77 events/hour for the two trials. Evaluable endpoint populations were 100/86 and 110/87; safety populations were 114/120 and 119/114, with follow-up through week 56. Serious-event counts agree with the publication. The trials with and without background PAP remain separate comparisons.
Inspect NCT05412004 resultsLiterature search cutoff: 2026-09-08 · Not independently clinically reviewed
Browse study library