Core Insights - Eli Lilly's tirzepatide demonstrated significant efficacy in reducing the severity of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, achieving a reduction of up to 62.8% in apnea-hypopnea index (AHI) [1][2][3] - The company has submitted tirzepatide for regulatory approval to the U.S. FDA for the treatment of moderate-to-severe OSA and obesity, with plans for submissions to other global regulatory agencies [1][7] Efficacy Results - In the SURMOUNT-OSA phase 3 clinical trials, tirzepatide resulted in a mean reduction of approximately 30 fewer events per hour of sleep compared to placebo [1][3] - Key secondary endpoints showed that 43.0% and 51.5% of participants at the highest dose achieved disease resolution, defined as an AHI of fewer than 5 events per hour or an AHI of 5-14 with an Epworth Sleepiness Scale score of ≤10 [2][5] Safety Profile - The overall safety profile of tirzepatide in the SURMOUNT-OSA studies was consistent with previous trials, with gastrointestinal issues being the most commonly reported adverse events [6][7] - Adverse events led to treatment discontinuation in 9 participants taking tirzepatide and 10 taking placebo [6] Market Context - There are currently no pharmaceutical treatments addressing the underlying causes of OSA, which affects approximately 80 million people in the U.S. and is linked to serious health complications [6][7] - Tirzepatide is the only approved treatment that combines GIP and GLP-1 mechanisms for chronic weight management, marketed as Zepbound® in the U.S. and Mounjaro® in other markets [7][30]
Lilly's tirzepatide reduced obstructive sleep apnea (OSA) severity, with up to 51.5% of participants meeting the criteria for disease resolution