Nearly two years after Eli Lilly’s Zepbound snagged the FDA’s first approval for a drug in obstructive sleep apnea, the company plans to submit Foundayo in the same indication after the oral GLP-1 drug significantly reduced the severity of the disease in a late-stage trial.
In the Phase 3 ATTAIN-OSA study, Foundayo—also known as orforglipron—significantly reduced scores on a scale measuring sleep apnea severity after 52 weeks, meeting the trial’s primary endpoint. The trial included around 712 people with moderate-to-severe obstructive sleep apnea and obesity or overweight. Foundayo reduced breathing interruptions during sleep by up to 44% on average, Lilly reported on Monday, with up to 32% of participants achieving disease remission or mild disease.
Treatment with the GLP-1 pill also reduced sleep apnea–specific hypoxic burden, which measures how deeply and for how long oxygen levels fall during sleep, by 55.9% in patients who do not use positive airway pressure (PAP) therapy, and by 45.8% in those who do use such a machine or mask, meeting one of the trial’s secondary endpoints.
As for safety, Foundayo’s profile was “generally consistent” with previous trials in Lilly’s ACHIEVE and ATTAIN programs, the company said in its press release. In the cohort of patients not using PAP therapy, 12.2% discontinued Foundayo treatment due to adverse events, versus 3.8% of those on placebo. Discontinuations were lower among those using PAP assistance, with 6.8% of participants on Foundayo and 0.6% of placebo recipients dropping out.
Based on these results, Lilly intends to submit an application for Foundayo in this indication to the FDA before the end of this year.
Foundayo was approved in April for weight loss, three months behind rival Novo Nordisk’s oral Wegovy. Earlier this month, Lilly reported that Foundayo has secured 40% of new patient starts since the oral GLP-1 entered the market in the second quarter. But Novo CEO Mike Maziar Doustdar disputed that number, suggesting the split is 80% to 20% in favor of his company.
The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.
April 1, 2026
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Meanwhile, Lilly is looking to double down in the sleep apnea space. The company’s blockbuster GIP and GLP-1 agonist Zepbound secured approval for the indication in December 2024 for adults with moderate-to-severe obstructive sleep apnea and obesity after the Phase 3 SURMOUNT-OSA trial showed the drug was five times more effective than placebo in reducing breathing disruptions in adults not on PAP therapy.
Wegovy, meanwhile, is not approved for sleep apnea. However, a posthoc analysis of the pivotal SELECT trial presented by Novo at the American Diabetes Association’s annual conference in June showed a “significantly lower” incidence of the condition in adults with overweight or obesity and established cardiovascular disease who took the drug as compared with placebo.
Novo CEO Mike Maziar Doustdar insists that his company is ahead of fierce rival Eli Lilly as oral Wegovy rises to 8 million total prescriptions since its January launch.
November 4, 2026
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