Eli Lilly Seeks Zepbound Approval for Sleep Apnea Post Successful Trial

Eli Lilly has announced that its weight-loss drug, Zepbound (tirzepatide), has shown significant improvements in obstructive sleep apnea (OSA) symptoms during the Phase III SURMOUNT-OSA study. The company plans to submit the study's topline data to the FDA and global health authorities by mid-year, with the drug already having received the FDA’s Fast Track designation for moderate-to-severe OSA.

The study involved 469 participants with OSA and obesity, and was split into two parts: one for patients who could not or chose not to use positive airway pressure (PAP), and another for those who were using and intended to continue using PAP. At the end of 52 weeks, the drug demonstrated a substantial reduction in the apnea-hypopnea index (AHI), a measure of OSA severity, in both groups. The first group saw a mean reduction of 27.4 events per hour, compared to a 4.8 events per hour reduction in the placebo group. The second group experienced a mean AHI reduction of 30.4 events per hour, with the placebo group showing a decrease of 6.0 events per hour.

The drug also resulted in greater weight loss compared to placebo in both study parts. Safety-wise, tirzepatide’s side effects were mild to moderate and consistent with previous trials, primarily gastrointestinal in nature.

The SURMOUNT-OSA study's findings add to the growing evidence of the effectiveness of GLP-1 receptor agonists against various diseases. Recently, the FDA approved Novo Nordisk’s Wegovy (semaglutide) for reducing cardiovascular risks in overweight and obese adults with heart disease. Additionally, Boehringer Ingelheim’s survodutide showed promise in treating metabolic dysfunction-associated steatohepatitis in a Phase II study.

The potential approval of tirzepatide for OSA could fill a significant medical gap, as it could be the first pharmaceutical treatment targeting the underlying disease, not just the symptoms of excessive sleepiness associated with OSA. Currently, more than 20 million adults in the U.S. are believed to suffer from moderate-to-severe OSA, with the majority of these cases going undiagnosed and untreated.