On Friday, Eli Lilly And Co (NYSE: LLY) released detailed results from the SURMOUNT-OSA phase 3 trials evaluating tirzepatide injection (10 mg or 15 mg) for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, with and without positive airway pressure (PAP) therapy.
In both studies, tirzepatide achieved all primary and key secondary endpoints for both the efficacy and treatment-regimen estimands and demonstrated a mean reduction of up to 62.8% on the apnea-hypopnea index (AHI), or about 30 fewer events restricting or blocking a person's airflow per hour of sleep, compared to placebo.
In a key secondary endpoint, the efficacy estimand showed that 43.0% (Study 1) and 51.5% (Study 2) of participants treated with tirzepatide at the highest dose met the criteria for disease resolution.
In this context, "disease resolution" means achieving an AHI of fewer than 5 events per hour, or an AHI of 5-14 events per hour and an Epworth Sleepiness Scale (ESS) score of ≤10.
ESS is a standard questionnaire designed to assess excessive daytime sleepiness.
In SURMOUNT-OSA 1, tirzepatide injection led to a mean AHI reduction of 27.4 events per hour from baseline compared to 4.8 in the placebo arm.
In the second study, there was a mean AHI reduction of 30.4 events per hour from baseline versus 6.0 on the placebo arm.
The weight loss was, on average, 18.1% in OSA 1 and 20.1% in OSA 2.
Participants treated with tirzepatide in both studies experienced significant improvements in all key secondary endpoints including systolic blood pressure, hypoxic burden, and high-sensitivity C-reactive protein, an inflammation marker, compared to placebo.
Tirzepatide is approved for chronic weight management, commercialized as Zepbound in the U.S. and Mounjaro in some global markets outside the U.S.
Lilly submitted tirzepatide for the treatment of moderate-to-severe OSA and obesity to the FDA with regulatory action anticipated as early as the end of this year.
Price Action: LLY shares are up 1.24% at $894.88 during the premarket session at last check Monday.