Eli Lilly and Company (NYSE: LLY) has announced promising results from the SURMOUNT-OSA phase 3 clinical trials of tirzepatide, a novel treatment aimed at moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. Detailed results, published in The New England Journal of Medicine and presented at the American Diabetes Association’s 84th Scientific Sessions, reveal significant reductions in the apnea-hypopnea index (AHI) and substantial improvements in disease resolution rates.

Tirzepatide achieved all primary and key secondary endpoints in both trials. Patients treated with the highest doses of tirzepatide experienced a mean reduction of up to 62.8% in AHI, equating to approximately 30 fewer events of restricted airflow per hour of sleep compared to placebo. Notably, 43.0% of participants in Study 1 and 51.5% in Study 2 met the criteria for disease resolution, defined as achieving an AHI of fewer than 5 events per hour.

OSA not only disrupts sleep but can also exacerbate serious cardiometabolic conditions such as hypertension and type 2 diabetes. Participants in the SURMOUNT-OSA trials observed significant improvements in systolic blood pressure, hypoxic burden, and levels of high-sensitivity C-reactive protein, a marker of inflammation, demonstrating tirzepatide’s potential to positively influence overall health outcomes.

Dr. Atul Malhotra, a leading expert in sleep medicine from the University of California San Diego, emphasized the transformative impact of tirzepatide: “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.” Jeff Emmick, MD, Ph.D., SVP of Product Development at Lilly, also highlighted the absence of pharmaceutical treatments addressing the underlying causes of OSA, underscoring the significance of tirzepatide’s potential in this field.

Tirzepatide, marketed under the names Zepbound in the U.S. and Mounjaro internationally for chronic weight management, is now under review by the FDA for treating moderate-to-severe OSA, with potential approval expected by the end of the year. The overall safety profile of tirzepatide in the SURMOUNT-OSA studies aligns with previous findings, with gastrointestinal issues being the most common mild to moderate adverse events.

With the FDA granting Fast Track designation for tirzepatide’s use in OSA patients with obesity, Eli Lilly is poised to address a significant unmet need in the management of this complex disorder. The drug’s ability to improve sleep quality and reduce the risk of associated health complications could mark a significant advancement in treating OSA.

  cardiometabolic health, Eli Lilly, Lilly, obesity treatment, obstructive sleep apnea, SURMOUNT-OSA clinical trials, Tirzepatide