Clinical Trials

The drug also met its secondary endpoints of percentage change in AHI in both key studies.

The first study assessed the drug in adults with moderate-to-severe OSA and obesity who were not on any positive airway pressure (PAP) therapy for 52 weeks; in this trial the drug led to a mean AHI reduction from baseline of 27.4 events per hour compared to a mean AHI reduction of 4.8 events per hour for placebo.

The second study 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 trial, the drug led to a mean AHI reduction from baseline of 30.4 events per hour compared to a mean AHI reduction of 6.0 events per hour for placebo.

Jeff Emmick MD PhD, senior vice president of product development at Eli Lilly, commented: “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.”

According to the press release, the ‘SURMOUNT-OSA trials will be presented during a symposium at the American Diabetes Association’s 84th Scientific Sessions on 21 June at 3:45 pm ET and submitted to a peer-reviewed journal. Based on these results, Lilly plans to submit to the US Food and Drug Administration (FDA) and other global regulatory agencies beginning mid-year. Lilly received FDA Fast Track designation for moderate-to-severe OSA and obesity’.