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Eli Lilly has announced results from its Phase III clinical trials of tirzepatide for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, with and without positive airway pressure (PAP) therapy. In both studies, tirzepatide achieved all primary and key secondary endpoints for both the efficacy and treatment-regimen estimands.1
In the primary endpoint, tirzepatide reduced moderate-to-severe OSA severity by up to 62.8%, which is representative of 30 fewer events restricting or blocking a person’s airflow per hour of sleep, compared to placebo. In a key secondary endpoint from two clinical studies, 3.0% and 51.5% of participants taking tirzepatide at the highest dose reached the criteria for disease resolution. Defined by the apnea-hypopnea index (AHI) and Epworth Sleepiness Scale (ESS) measures, “disease resolution” means achieving an AHI of fewer than 5 events per hour, or an AHI of 5-14 events per hour and an ESS score of ≤10.
According to Lilly, the Phase III clinical trial, SURMOUNT-OSA (NCT05412004), were a set of multi-center, randomized, double-blind, parallel studies comparing the efficacy and safety of tirzepatide to placebo in adults living with moderate-to-severe obstructive sleep apnea and obesity who were unable or unwilling to use positive airway pressure (PAP) therapy (study 1) and those who were and planned to stay on PAP therapy during the duration of the trial (study 2). The trials randomized 469 participants across the US, Australia, Brazil, China, Czechia, Germany, Japan, Mexico, and Taiwan.
“In the trials, patients with moderate-to-severe obstructive sleep apnea and obesity treated with tirzepatide experienced about 30 fewer disruptive events every hour of sleep and nearly half achieved disease resolution,” Atul Malhotra, MD, Peter C. Farrell presidential chair, professor of medicine at University of California San Diego School of Medicine and director of sleep medicine at UC San Diego Health said in a press release. “OSA can be very disruptive to daily life and affects a person’s long-term health when left untreated because it can lead to serious cardiometabolic complications. These data support the efficacy of tirzepatide in adults living with moderate-to-severe OSA and obesity and has the potential to add to our toolbox for OSA treatment.”
According to Mayo Clinic, OSA is the most common sleep-related breathing disorder. While there are several types of sleep apnea, OSA occurs when the throat muscles relax and block the airway.2 It is estimated that 936 million adults around the world have mild to severe OSA.3
Lilly has submitted tirzepatide for the treatment of moderate-to-severe OSA and obesity to the FDA and will initiate submissions for other global regulatory agencies in the coming weeks. Tirzepatide is currently the only approved GIP and GLP-1 treatment for chronic weight management.
“There are currently no pharmaceutical treatment options to address the underlying cause of OSA, a complex disease that disrupts the daily lives of 80 million people in the US alone and is linked to serious health complications,” Jeff Emmick, MD, PhD, senior vice president, product development, Lilly said in the press release. “The SURMOUNT-OSA results showed a significant proportion of patients with moderate-to-severe OSA and obesity treated with tirzepatide achieved disease resolution based on predetermined AHI and ESS measures, at which point PAP therapy may not be recommended.”
References
1. Lilly’s tirzepatide reduced obstructive sleep apnea (OSA) severity, with up to 51.5% of participants meeting the criteria for disease resolution. Eli Lilly. News release. June 21, 2024. Accessed June 24, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-tirzepatide-reduced-obstructive-sleep-apnea-osa-severity.
2. Obstructive sleep apnea. Mayo Clinic. July 14, 2023. Accessed June 24, 2024. https://www.mayoclinic.org/diseases-conditions/obstructive-sleep-apnea/symptoms-causes/syc-20352090#:~:text=Obstructive%20sleep%20apnea%20is%20the,relax%20and%20block%20the%20airway.
3. Sleep Apnea Statistics and Facts You Should Know. National Council on Aging. May 8, 2024. Accessed June 24, 2024. https://www.ncoa.org/adviser/sleep/sleep-apnea-statistics/.
