Tirzepatide Shows Promise in Reducing Sleep Apnea Severity in Adults with Obesity: SURMOUNT-OSA Trial

Tirzepatide significantly reduced the apnea-hypopnea index (AHI) relative to placebo therapy—paving the way for the company to submit a mid-year application for approval in moderate-to-severe OSA and obesity.

Tirzepatide is the only approved GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) treatment for chronic weight management, commercialized as Zepbound in the U.S. and Mounjaro in some global markets outside the U.S.

A combination of 2 studies investigating tirzepatide in adults with OSA, results indicate tirzepatide use reduced AHI in patients with OSA, with this benefit observed regardless of positive airway pressure (PAP) therapy. Further analysis of both studies showed that tirzepatide provided benefits for secondary outcomes, including mean AHI percentage reduction and body weight reduction from baseline to week 52.

"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," Jeff Emmick, senior vice president of product development at Lilly, said in a press release.

"Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease."

SURMOUNT-OSA Study 1 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were not on positive airway pressure (PAP) therapy for 52 weeks.

For the efficacy estimands, at 52 weeks, tirzepatide led to a mean AHI reduction from baseline of 27.4 events per hour compared to a mean AHI reduction from baseline of 4.8 events per hour for placebo. In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 55.0% compared to 5.0% from baseline for placebo; tirzepatide also led to a mean body weight reduction of 18.1% from baseline, compared to 1.3% from baseline for placebo.

SURMOUNT-OSA Study 2 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were on and planned to continue to use PAP therapy for 52 weeks.

In this population for the efficacy estimand, at 52 weeks, tirzepatide led to a mean AHI reduction from baseline of 30.4 events per hour compared to a mean AHI reduction from baseline of 6.0 events per hour for placebo. In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 62.8% compared to 6.4% from baseline for placebo; tirzepatide also led to a mean body weight reduction of 20.1% from baseline, compared to 2.3% from baseline for placebo.

The weight loss observed at 52 weeks with tirzepatide (10 mg and 15 mg) across the two studies was nearly 20% in a patient population comprising approximately 70% males, who are known to achieve less weight loss with incretin therapy than females.