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In the primary endpoint, tirzepatide reduced moderate-to-severe OSA severity by up to 62.8% (about 30 fewer events per hour)
In a key secondary endpoint from two clinical studies, 43.0% and 51.5% of participants taking tirzepatide at the highest dose reached the criteria for disease resolution as defined by apnea-hypopnea index and Epworth Sleepiness Scale measures
Lilly submitted tirzepatide for the treatment of moderate-to-severe OSA and obesity to the U.S. Food and Drug Administration (FDA) and will initiate submissions for other global regulatory agencies in the coming weeks
INDIANAPOLIS, June 21, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced detailed results from the SURMOUNT-OSA phase 3 clinical trials evaluating tirzepatide injection (10 mg or 15 mg) 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 efficacyi and treatment-regimenii estimands and demonstrated a mean reduction of up to 62.8% on the apnea-hypopnea index (AHI), or about 30 fewer events restricting or blocking a person's airflow per hour of sleep, compared to placebo. Full results were published in The New England Journal of Medicine (NEJM) and presented at the American Diabetes Association® (ADA) 84th Scientific Sessions.
In a key secondary endpoint, the efficacy estimand showed that 43.0% (Study 1) and 51.5% (Study 2) of participants treated with tirzepatide at the highest dose met the criteria for disease resolution. In this context, "disease resolution" means achieving an AHI of fewer than 5 events per hour, or an AHI of 5-14 events per hour and an Epworth Sleepiness Scale (ESS) score of ≤10. ESS is a standard questionnaire designed to assess excessive daytime sleepiness.1-4
OSA is a complex disease that can impact the progression of serious cardiometabolic complications, including hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation and type 2 diabetes.5 Participants treated with tirzepatide in both studies experienced significant improvements in all key secondary endpoints including systolic blood pressure, hypoxic burden and high-sensitivity C-reactive protein (hsCRP), an inflammation marker, compared to placebo.
"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," said 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. "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."
Full Results: | ||
SURMOUNT-OSA Study 1 – Participants Not on PAP Therapy | ||
Efficacy Estimand Resultsat 52 Weeks | Treatment-Regimen Estimand Results at 52 Weeks | |
Primary Endpoint – Change in AHI from Baseline | ||
Tirzepatide* | -27.4 | -25.3 |
Placebo | -4.8 | -5.3 |
Secondary Endpoint – Percent Change in AHI from Baseline | ||
Tirzepatide* | -55.0 % | -50.7 % |
Placebo | -5.0 % | -3.0 % |
Secondary Endpoint – Percentage of Participants with AHI | ||
