Tirzepatide for OSA in adults with obesity: SURMOUNT-OSA
Two parallel 52-week phase-3 trials of tirzepatide in moderate-to-severe OSA: one without concurrent PAP therapy, one with. Both met their primary endpoints with substantial AHI reductions and adjunctive weight loss.
Trial 1 — without PAP
234 adults with moderate-to-severe OSA, BMI ≥ 30, not on PAP. Mean AHI reduction at 52 weeks: tirzepatide −27.4 events/hour vs placebo −4.8 events/hour (between-group difference −20.0, p < 0.001).
Trial 2 — with PAP
235 adults on stable PAP therapy. Mean AHI reduction: tirzepatide −29.3 vs placebo −5.5 (between-group difference −23.8, p < 0.001).
Disease-resolution rates
Across both trials, roughly 40–50% of tirzepatide-treated participants achieved AHI < 5 events/hour (a threshold often used for clinical remission), vs 14–15% on placebo.
FDA approval
On December 20, 2024, the FDA approved tirzepatide (Zepbound) for moderate-to-severe OSA in adults with obesity — the first medication ever approved for OSA.