Tirzepatide Improved Sleep Disordered Breathing in Adults with Obstructive Sleep Apnea with Obesity: Results from SURMOUNT-OSA Trials.

How efficacious and safe was tirzepatide in treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity?

Methodology: SURMOUNT-OSA (NCT05412004) is a master protocol guiding 2 randomized, placebo-controlled trials investigating the efficacy and safety of tirzepatide to placebo in adults living with moderate-to-severe OSA with obesity. Under a master protocol, the two trials were composed of trial 1: included participants who were unable or unwilling to use positive airway pressure (PAP) therapy, and trial 2: included participants who were and planned to stay on PAP therapy during the 52 week duration of the trials. Overall, in the two trials 469 participants were randomized in a 1:1 ratio to receive tirzepatide maximum tolerated dose (MTD) 10 or 15 mg once weekly, or placebo.

Results: At baseline, mean apnea-hypopnea index (AHI) was 50.1 events/hour and mean body mass index was 38.8 kg/m^2. Tirzepatide-treatment was associated with mean AHI reductions from baseline to week 52 of 27.4 (55.0%) and 30.4 (62.8%) events per hour compared to 4.8 (5.0%) and 6.0 (6.4%) events per hour for placebo in trial 1 and trial 2, respectively. Moreover, tirzepatide-treatment was associated with to a mean body weight reduction from baseline of 18.1% and 20.1%, compared to 1.3% and 2.3% for placebo, in trial 1 and trial 2, respectively. The overall safety profile of tirzepatide in SURMOUNT-OSA studies was similar to previously reported SURMOUNT trials. The most commonly reported adverse events in SURMOUNT-OSA trials were gastrointestinal-related and generally mild to moderate in severity and occurred during dose escalation.

Conclusion: Tirzepatide-treatment occurred with clinically meaningfully improved sleep disordered breathing compared to placebo in adults with moderate-to-severe OSA with obesity, with consistent findings across the two trials.

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Interessenkonflikt

A.M. reports research grant fees and/or personal expenses for: Eli Lilly and Company, Jazz Pharmaceuticals, LivaNova, National Institutes of Health (NIH), ResMed, and Zoll Medical. R.G. reports consultant fees for: Apnimed and Eli Lilly and Company. I.F. reports consultant and/or lecturer fees and/or research grants for: Eli Lilly and Company, Hennig, Idorsia, L ̈o.ensteinMedical, ResMed, and Stada Arzneimittel AG. T.W. reports consultant and/or consulting fees and/or personal expenses for: Alkermes Orexin Advisory Board, Axsome Therapeutics, Bayer AG, Bioprojet Deutschland GmbH, Eli Lilly and Company, Harmony Biosciences, Idorsia Alliance for Sleep, Ignis Therapeutics (Shanghai) Ltd., Inspire Medical Systems, IQVIA Technologies, Jazz Pharmaceuticals, LivaNova, Nyxoah, Philips Respironics, ResMed, Signant Health, Signifier Medical Technologies, Stratevi, Syneos Health, Vallis Bioscience, and Verily Life Sciences. J.P.D., S.C., M.C.B., J.B. and M.H. are employees and shareholders of Eli Lilly and Company.

Publication History

Article published online:
28 May 2025