Lilly announces significant results in SURMOUNT-OSA trials of tirzepatide in OSA

Eli Lilly and Company (NYSE: LLY) has released positive topline results from the phase 3 SURMOUNT-OSA clinical trials, demonstrating that tirzepatide injection significantly reduces the apnea-hypopnea index (AHI) compared to placebo. Tirzepatide, already known for chronic weight management under the brand names Zepbound in the U.S. and Mounjaro globally, now shows promise in treating moderate-to-severe obstructive sleep apnea (OSA) combined with obesity.

The first SURMOUNT-OSA study focused on adults not using positive airway pressure (PAP) therapy, where tirzepatide achieved a mean AHI reduction of 27.4 events per hour over a year, markedly better than the 4.8 events reduced by the placebo. Additionally, tirzepatide prompted an 18.1% body weight reduction, significantly surpassing the 1.3% reduction with placebo. In the second study, which included PAP therapy users, tirzepatide led to a 30.4 events per hour reduction in AHI and a 20.1% decrease in body weight, both substantially better than the placebo’s results.

“OSA impacts 80 million adults in the U.S., with more than 20 million living with moderate-to-severe OSA. However, 85% of OSA cases go undiagnosed and therefore untreated,” explained Jeff Emmick, MD, Ph.D., senior vice president, product development at Lilly. He highlighted the critical need for effective treatments, noting that while there are treatments for OSA-related sleepiness, tirzepatide could be the first to target the underlying disease.

The safety profile of tirzepatide in these trials was consistent with previous studies, featuring mostly mild to moderate gastrointestinal-related adverse events. Eli Lilly plans to submit these findings for regulatory review mid-year and will present more detailed data at the American Diabetes Association’s 84th Scientific Sessions on June 21.

SURMOUNT-OSA is a multi-center, randomized, double-blind trial comparing tirzepatide and placebo over 52 weeks. With participants from various countries, the study evaluates the efficacy of tirzepatide in adults with moderate-to-severe OSA and obesity, particularly those unable or unwilling to use PAP therapy.