In both the late-stage trials, the drug reduced the AHI against the placebo and achieved a mean AHI reduction of up to 63%, meeting all primary and key secondary endpoints
A product shot of tirzepatide 15mg. (Credit: Lilly USA, LLC)
Eli Lilly and Company (Lilly) said that its weight loss drug tirzepatide injection has reduced the severity of obstructive sleep apnoea (OSA) in two SURMOUNT-OSA Phase 3 clinical trials in patients with moderate-to-severe OSA and obesity.
Tirzepatide is an approved glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) therapy for chronic weight management.
It is being sold under the brand name Zepbound in the US and Mounjaro in a few international markets outside the country.
The randomised, double-blind, parallel, placebo-master protocol SURMOUNT-OSA studies compared the efficacy and safety of tirzepatide against placebo from baseline at 52 weeks.
Study 1 assessed individuals who were unable or unwilling to use positive airway pressure (PAP) therapy. On the other hand, study 2 evaluated patients who were and planned to stay on PAP therapy during the trial.
Under a master protocol, both trials randomised 469 participants in a 1:1 ratio to receive tirzepatide maximum tolerated dose (MTD) of 10mg or 15mg or placebo.
The primary endpoint was defined as the change in apnea-hypopnea index (AHI) from baseline at 52 weeks as compared to placebo.
According to the results, the drug significantly reduced the AHI against the placebo. It achieved a mean AHI reduction of up to 63%, meeting all primary and key secondary endpoints in both the late-stage trials.
Additionally, the GIP and GLP-1 therapy led to a mean body weight reduction of 18.1% from baseline in patients not on PAP therapy. Tirzepatide also led to a mean body weight reduction of 20.1% from baseline in individuals on PAP therapy.
The safety profile of the drug in the SURMOUNT-OSA studies was found similar to data in previously reported SURPASS and SURMOUNT trials.
Lilly product development senior vice president Jeff Emmick said: “OSA impacts 80 million adults in the US, with more than 20 million living with moderate-to-severe OSA. However, 85% of OSA cases go undiagnosed and therefore untreated.
“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.”
Lilly intends to submit these findings to the US Food and Drug Administration (FDA) and other global regulatory agencies starting in the middle of the year.
The pharma major has FDA fast track designation for the drug to treat moderate-to-severe obstructive sleep apnoea (OSA) and obesity.