Eli Lilly's Foundayo Shows Sleep Apnea Improvement in Late‑Stage Trial

LLY said its once-daily GLP-1 pill Foundayo (orforglipron) met the primary endpoint in ATTAIN-OSA, a 52-week Phase 3 program in 712 adults with moderate-to-severe obstructive sleep apnea and obesity or overweight. In the 363 participants not using positive airway pressure (PAP) therapy, Foundayo reduced the apnea-hypopnea index (AHI) by 21.1 events per hour, or 43.8%, versus 6.3% on placebo; in the 349 participants already on PAP, the reduction was 18.3 events per hour, or 27.5%, versus 3.0%.

The secondary results were broad. 31.5% of the no-PAP group and 19.6% of the PAP group reached remission or mild disease, participants lost 11.5% and 11.2% of body weight respectively, and systolic blood pressure fell by 8.6 mmHg and 7.3 mmHg. The results were published in JAMA and presented at the American Heart Association's Scientific Sessions. Tolerability is the trade-off to watch: discontinuations due to adverse events were 12.2% on Foundayo versus 3.8% on placebo in the no-PAP study, and 6.8% versus 0.6% in the PAP study, with mostly mild-to-moderate gastrointestinal side effects.

Lilly plans to submit Foundayo to the FDA for moderate-to-severe obstructive sleep apnea by the end of 2026. The indication is not new territory for the company: its injectable Zepbound became the first medication approved for sleep apnea in December 2024, and Foundayo itself launched in the U.S. in April for weight management. A pill option could widen the treatable population, and the label filing, FDA timeline and how prescribers weigh the higher dropout rate against injectables are the markers to follow.