The molecule tirzepatide is a 39 amino acid linear peptide conjugated to a C20 fatty acid moiety. Tirzepatide image from Lilly.
Today, Lilly announced promising data for the SURMOUNT-OSA phase 3 clinical trials testing tirzepatide in adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. The company shared the data at the American Diabetes Association’s (ADA) 84th Scientific Sessions while publishing them in The New England Journal of Medicine (NEJM).
The SURMOUNT-OSA phase 3 trial consists of two studies. In both the first and second studies, tirzepatide hit all primary and key secondary endpoints for efficacy. The drug was associated with a mean reduction of up to 62.8% on the apnea-hypopnea index (AHI), translating to roughly 30 fewer events restricting or blocking airflow per hour of sleep relative to placebo.
Tirzepatide, available as Mounjaro for type 2 diabetes and Zepbound for obesity, is already a central growth driver for Lilly. Tirzepatide alone saw $5.163 billion of sales in 2023. The therapy, a novel dual GIP/GLP-1 receptor agonist, could see a burgeoning number of indications, with trials underway for heart failure with preserved ejection fraction (HFpEF), obstructive sleep apnea, morbidity and mortality in obesity, cardiovascular outcomes, higher doses, and metabolic associated steatohepatitis (MASH).
“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, in a press release. Malhotra noted that the data underscore the efficacy of tirzepatide and adds that it “has the potential to add to [the physicians’] toolbox for OSA treatment.”
Improvements across a variety of measures in SURMOUNT-OSA
In the study, the drug significantly lowered the apnea-hypopnea index (AHI), body weight, hypoxic burden, high-sensitivity C-reactive protein (hsCRP) concentration and systolic blood pressure. It simultaneously improved sleep-related patient-reported outcomes in people with moderate-to-severe obstructive sleep apnea and obesity, compared to placebo over 52 weeks of treatment.
In addition to the significant reductions in the AHI, the tirzepatide cohort also saw significant weight loss. Patients experienced an average reduction of 16.1% (95% CI: -18.0 to -14.2) in Trial 1 and 17.3% (95% CI: –19.3 to –15.3) in Trial 2. Additionally, patients had significant reductions in the inflammatory marker high-sensitivity C-reactive protein (hsCRP) and improvements in systolic blood pressure (SBP) across both trials.
Filed Under: clinical trials, Drug Discovery, Metabolic disease/endicrinology
