Lilly's Foundayo Pill Cuts Sleep Apnea Events 44% in Phase 3, With FDA Filing Due by Year-End
In two 52-week studies of 712 adults with obesity or overweight, events fell 43.8% without PAP and 27.5% with PAP, and participants lost about 11% of body weight.
Eli Lilly ($LLY) said its once-daily oral GLP-1 Foundayo (orforglipron) significantly reduced obstructive sleep apnea (OSA) severity in adults with obesity or overweight in a 52-week Phase 3 program. Among people who did not use positive airway pressure (PAP) therapy, sleep apnea events fell 43.8% versus 6.3% with placebo. Lilly plans to submit Foundayo to the FDA for OSA by the end of 2026.
The ATTAIN-OSA results
The two studies enrolled 712 adults with moderate-to-severe OSA and obesity or overweight: 363 who could not or would not use PAP and 349 who stayed on PAP therapy. Participants took Foundayo once a day, with the dose raised every four weeks to a maximum tolerated dose of 9 mg, 14.5 mg or 17.2 mg. The trial met its primary endpoint, the change in the apnea-hypopnea index (AHI), which counts breathing interruptions per hour of sleep. Lilly presented the data at the American Heart Association Scientific Sessions and published them in JAMA.
| Measure at 52 weeks | Study 1: without PAP | Study 2: with PAP |
|---|---|---|
| Participants | 363 | 349 |
| Baseline AHI (events per hour) | 50.7 | 57.6 |
| Change in AHI (events per hour) | -21.1 vs -4.3 placebo | -18.3 vs -5.5 placebo |
| Percent change in AHI | -43.8% vs -6.3% placebo | -27.5% vs -3.0% placebo |
| Sleep apnea hypoxic burden | -55.9% vs -18.3% placebo | -45.8% vs -17.0% placebo |
| Remission or mild OSA | 31.5% | 19.6% |
| Body weight | -11.5% (-28.0 lbs) vs -1.8% | -11.2% (-28.2 lbs) vs -0.9% |
| Systolic blood pressure | -8.6 mmHg | -7.3 mmHg |
| hsCRP (inflammation marker) | -48.9% | -38.6% |
| Stopped treatment because of side effects | 12.2% vs 3.8% placebo | 6.8% vs 0.6% placebo |
Results use the efficacy estimand, which measures the effect while participants were taking the treatment. Remission means an AHI below 5 events per hour; mild OSA means an AHI of 5 to under 15 with an Epworth Sleepiness Scale score of 10 or less. The gap between Foundayo and placebo in percent AHI change was about 37.5 percentage points without PAP and 24.5 points with PAP.
Safety
- Side effects. Lilly said the safety profile was generally consistent with earlier ACHIEVE and ATTAIN trials. The most common adverse events were gastrointestinal, including nausea, diarrhea, constipation, dyspepsia and vomiting, and were generally mild to moderate.
- Discontinuations. Treatment stopped because of adverse events for 12.2% of Foundayo patients versus 3.8% on placebo without PAP, and 6.8% versus 0.6% with PAP.
- Labeling. Foundayo's approved U.S. labeling carries warnings including thyroid tumor risk, pancreatitis, dehydration-related kidney problems, gallbladder problems and aspiration risk during anesthesia.
How it fits Lilly's obesity portfolio
Foundayo is FDA-approved in the U.S. for chronic weight management in adults with obesity, and some adults with overweight who have weight-related medical problems, and is approved in several other countries. Lilly's injectable Zepbound (tirzepatide) is already approved for moderate-to-severe OSA in adults with obesity. In its 2024 SURMOUNT-OSA trials, tirzepatide cut AHI by 55.0% without PAP and 62.8% with PAP, versus 5.0% and 6.4% with placebo, and 43.0% and 51.5% of participants reached disease resolution. Those trials differed in design and populations, so the figures are not a head-to-head comparison. Lilly is also studying the injectable retatrutide for OSA in Phase 3. Thomas Seck, M.D., senior vice president of product development for Lilly Cardiometabolic Health, called OSA one of the most serious complications of obesity and closely linked to cardiovascular disease. Vaishnavi Kundel, M.D., of the Icahn School of Medicine at Mount Sinai, said Foundayo reduced breathing interruptions and oxygen drops during sleep and improved blood pressure and inflammation.
Shares
Lilly shares were up 3.51%, or $47.54, at $1,401.53 as of 10:45 a.m. ET Monday, about 3.3% below the 52-week high of $1,449.68. The company's market value was $1.32 trillion. In its third-quarter results, Lilly reported revenue of $24.40 billion and raised full-year 2026 revenue guidance to $91.0 billion to $92.0 billion, according to a TipRanks summary on Google Finance.
What to watch
- FDA submission. Whether Lilly files by the end of 2026 as planned, and the review timeline that follows.
- Competitive position. How Foundayo's OSA results stack up against Zepbound and retatrutide as doctors weigh pills against injections.
- Other indications. Results from ATTAIN-Hypertension and Lilly's other Foundayo studies, including type 2 diabetes, knee osteoarthritis pain and peripheral artery disease.
- Tolerability. Whether the higher discontinuation rates in the Foundayo arms affect real-world use.
- Related coverage. See our AeroVironment contract report, the Nvidia investigation story and the Google and Crusoe report.
Sources: Lilly's Nov. 9 press release and Lilly's 2024 SURMOUNT-OSA announcement. Share prices are from Google Finance. This article is informational only and is not investment advice or medical advice.
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