Eli Lilly and Company announced that their drug tirzepatide significantly reduced the severity of obstructive sleep apnea (OSA) in clinical trials, with up to 51.5% of participants meeting the criteria for disease resolution.
In the primary endpoint, tirzepatide reduced moderate-to-severe OSA severity by up to 62.8%, equating to approximately 30 fewer apnea events per hour.
Secondary endpoints from two clinical studies showed that 43.0% and 51.5% of participants taking the highest dose of tirzepatide met the criteria for disease resolution, which is defined by the apnea-hypopnea index (AHI) and Epworth Sleepiness Scale (ESS) measures.
Lilly has submitted tirzepatide for the treatment of moderate-to-severe OSA and obesity to the U.S. Food and Drug Administration (FDA) and plans to begin submissions to other global regulatory agencies soon.
Clinical Trial Insights: SURMOUNT-OSA Phase 3
The SURMOUNT-OSA phase 3 clinical trials evaluated the efficacy of tirzepatide injections (10 mg or 15 mg) in treating moderate-to-severe OSA in obese adults, both with and without positive airway pressure (PAP) therapy. The trials achieved all primary and key secondary endpoints, demonstrating a mean reduction of up to 62.8% in the AHI, or about 30 fewer airflow-restricting events per hour compared to placebo.
In one key secondary endpoint, the efficacy estimand showed that 43.0% (Study 1) and 51.5% (Study 2) of participants receiving the highest dose of tirzepatide met the criteria for disease resolution. Disease resolution was defined as achieving an AHI of fewer than 5 events per hour or an AHI of 5-14 events per hour combined with an ESS score of 10 or lower. The ESS is a widely used questionnaire to measure excessive daytime sleepiness.
OSA is a multifaceted condition linked to serious cardiometabolic complications, such as hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation, and type 2 diabetes. Participants treated with tirzepatide in both studies showed significant improvements in secondary endpoints, including reductions in systolic blood pressure, hypoxic burden, and high-sensitivity C-reactive protein (hsCRP), an inflammation marker, compared to placebo.
Tirzepatide: A Dual-Action Treatment
Tirzepatide is the only approved treatment combining GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) for chronic weight management, known as Zepbound® in the U.S. and Mounjaro® in some international markets. Lilly has submitted tirzepatide for FDA approval to treat moderate-to-severe OSA and obesity, with regulatory action expected by the end of the year. The FDA has granted tirzepatide Fast Track designation for treating moderate-to-severe OSA in patients with obesity.
Details of the SURMOUNT-OSA Trials
The SURMOUNT-OSA trials (NCT05412004) were multi-center, randomized, double-blind, placebo-controlled studies comparing tirzepatide to placebo in adults with moderate-to-severe OSA and obesity. The trials included individuals who were either unable or unwilling to use PAP therapy (Study 1) and those who were using and planned to continue PAP therapy (Study 2). A total of 469 participants from the U.S., Australia, Brazil, China, Czechia, Germany, Japan, Mexico, and Taiwan were randomized in a 1:1 ratio to receive either the maximum tolerated dose (MTD) of tirzepatide (10 mg or 15 mg) or a placebo.
The primary objective of the studies was to demonstrate tirzepatide’s superiority in reducing the AHI from baseline over 52 weeks compared to placebo. Participants started with a 2.5 mg dose, which was increased by 2.5 mg every four weeks until the MTD was reached. Those who tolerated 15 mg continued at this dose, while those who tolerated 10 mg but not 15 mg continued at 10 mg as their MTD.
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