Lilly's tirzepatide lowers OSA severity, with up to 51.5% achieving disease resolution

Eli Lilly and Company announced promising results from phase 3 clinical trials examining the efficacy of tirzepatide in adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. The trials, known as SURMOUNT-OSA, evaluated tirzepatide in doses of 10 mg and 15 mg.

In terms of primary outcomes, tirzepatide demonstrated a significant reduction in the severity of OSA, showing a mean reduction of 62.8% in the apnea-hypopnea index (AHI). This translates to approximately 30 fewer events per hour that could restrict or block airflow during sleep compared to a placebo. These findings were published in The New England Journal of Medicine and presented at the American Diabetes Association's 84th Scientific Sessions.

Secondary outcomes were equally impressive, with 43.0% and 51.5% of participants in the two separate studies achieving criteria for disease resolution at the highest dose of tirzepatide. Disease resolution was defined by attaining an AHI of fewer than 5 events per hour, or an AHI between 5 and 14 events per hour coupled with an Epworth Sleepiness Scale (ESS) score of 10 or lower.

OSA is a multifaceted condition often linked to serious health issues like hypertension, coronary heart disease, and type 2 diabetes. The studies indicated that tirzepatide also led to significant improvements in secondary endpoints such as reductions in systolic blood pressure, hypoxic burden, and levels of high-sensitivity C-reactive protein (hsCRP), an inflammation marker.

Dr. Atul Malhotra, a professor of medicine at the University of California San Diego School of Medicine, noted that participants treated with tirzepatide experienced significant improvements in their OSA symptoms and overall health. He emphasized the potential of tirzepatide to become a valuable addition to the existing treatment options for OSA, a condition that can severely affect daily life and long-term health if left untreated.

Jeff Emmick, MD, Ph.D., senior vice president of product development at Lilly, highlighted the lack of pharmaceutical treatments for the underlying causes of OSA. He pointed out that the SURMOUNT-OSA results show a substantial proportion of patients achieving disease resolution, offering hope for reducing reliance on positive airway pressure (PAP) therapy.

The safety profile of tirzepatide observed in the SURMOUNT-OSA trials was consistent with previous studies. Common adverse events included gastrointestinal issues like diarrhea, nausea, and vomiting, which were generally mild to moderate in severity. A small percentage of participants discontinued the study treatment due to adverse events.

Tirzepatide, already approved for chronic weight management under the brand names Zepbound® in the U.S. and Mounjaro® in some global markets, has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe OSA and obesity. The drug has received FDA Fast Track designation for this indication, with regulatory action anticipated by the end of the year.

The SURMOUNT-OSA trials were multi-center, randomized, double-blind studies involving 469 participants from various countries. Participants were randomized to receive tirzepatide or placebo, starting at a dose of 2.5 mg and increasing every four weeks until the maximum tolerated dose of 10 mg or 15 mg was reached. The primary objective was to show the superiority of tirzepatide over placebo in reducing AHI over 52 weeks.

In summary, the phase 3 SURMOUNT-OSA trials demonstrate that tirzepatide could significantly reduce the severity of moderate-to-severe OSA in patients with obesity. With its promising results, tirzepatide has the potential to become an effective treatment option, pending regulatory approval.

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