Policy & Regulation
Eli Lilly announces detailed results from SURMOUNT-OSA phase three clinical trials of tirzepatide injection (10mg or 15mg)
24 June 2024 -

Eli Lilly and Company (NYSE: LLY), a United States-based pharmaceutical company, announced on Friday detailed results from the SURMOUNT-OSA phase three clinical trial, assessing tirzepatide injection (10mg or 15mg) intended for the treatment of moderate-to-severe obstructive sleep apnoea (OSA) in adults with obesity, with and without positive airway pressure (PAP) therapy.

The company said that 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 apnoea-hypopnea index (AHI), or about 30 fewer events restricting or blocking a person's airflow per hour of sleep, compared to placebo. Full results were published in The New England Journal of Medicine (NEJM) and presented at the American Diabetes Association (ADA) 84th Scientific Sessions.

Lilly submitted tirzepatide for the treatment of moderate-to-severe OSA and obesity to the US Food and Drug Administration (FDA) and says that it will initiate submissions for other global regulatory agencies in the coming weeks.

Atul Malhotra, MD, Peter C Farrell presidential chair, professor of medicine at University of California San Diego School of Medicine and director of sleep medicine at UC San Diego Health, said, 'In the trials, patients with moderate-to-severe obstructive sleep apnoea and obesity treated with tirzepatide experienced about 30 fewer disruptive events every hour of sleep and nearly half achieved disease resolution. OSA can be very disruptive to daily life and affects a person's long-term health when left untreated because it can lead to serious cardiometabolic complications. These data support the efficacy of tirzepatide in adults living with moderate-to-severe OSA and obesity and has the potential to add to our toolbox for OSA treatment.'