O064 Tirzepatide reduced sleep apnea severity in adults with obstructive sleep apnea and obesity: results from the SURMOUNT-OSA trial

Abstract Introduction We aimed to investigate the efficacy and safety of tirzepatide in treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. Methods SURMOUNT-OSA (NCT05412004) was a randomized, 52-week phase 3 trial comparing the efficacy and safety of tirzepatide to placebo in adults living with moderate-to-severe OSA and obesity. Under a master protocol, the trial involved Study 1, (participants who were unable or unwilling to use positive airway pressure (PAP), and Study 2, (participants who were and planned to stay on PAP therapy during the trial). 469 participants were randomised in a 1:1 ratio to receive tirzepatide maximum tolerated dose (MTD) 10 or 15 mg once weekly, or placebo. Results Baseline AHI (apnea-hypopnea index) and BMI were 50.1 events/h and 38.8 kg/m2. At 52 weeks, tirzepatide led to a mean AHI reduction from baseline 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 Study 1 and Study 2, respectively. Tirzepatide led to a mean weight reduction from baseline of 18.1% and 20.1%, compared to 1.3% and 2.3% for placebo, in Study 1 and Study 2, respectively. The most commonly reported adverse events in SURMOUNT-OSA studies were gastrointestinal-related and generally mild to moderate in severity in keeping with previous studies. Discussion Tirzepatide significantly reduced the AHI compared to placebo in adults with moderate-to-severe OSA and obesity, with and without PAP therapy, and therefore may represent a therapeutic option for this patient group.