Lilly’s weight-loss pill Foundayo cut sleep apnea breathing pauses in two yearlong trials; FDA filing planned by year’s end

A once-daily weight-loss pill from drugmaker Eli Lilly sharply reduced how often people with obstructive sleep apnea stopped breathing during sleep, according to two yearlong trials presented Nov. 9 at the American Heart Association’s Scientific Sessions in Chicago and published the same day in the medical journal JAMA.

The pill, Foundayo, whose scientific name is orforglipron, is a GLP-1 drug, a type of medicine that acts like a natural gut hormone called GLP-1.  Unlike Lilly’s injectable Zepbound, it is a pill rather than a shot, and Lilly says it can be taken at any time of day without food or water limits.  It is already approved in the U.S. for adults with obesity.  It is not approved for sleep apnea, and Lilly says it plans to ask the U.S. Food and Drug Administration for that approval by the end of 2026.

What sleep apnea is

In obstructive sleep apnea, the airway repeatedly collapses during sleep, causing drops in oxygen and spikes in blood pressure that are linked to high blood pressure, heart failure, an irregular heartbeat called atrial fibrillation, heart disease and stroke, Lilly says.  Lilly estimates that 936 million adults worldwide have it and that most have never been diagnosed.  Doctors measure it with an overnight sleep study that counts how many times an hour breathing stops or becomes shallow.  That count is called the apnea-hypopnea index.  Fifteen to 29 events an hour is moderate, and 30 or more is severe.  The most common treatment is a CPAP machine, which blows air through a mask to keep the airway open.

What the trials found

The program, called ATTAIN-OSA, enrolled 712 adults with moderate-to-severe sleep apnea, a body mass index of 27 or higher, meaning overweight or obesity, and no diabetes.  They were tested at 66 medical centers in North America, South America, Europe and Asia from October 2024 to July 2026.  Their average age was about 50, and about 30% were women.  One study included 363 people who did not use a breathing machine; the other included 349 people who did.  In each, half were picked at random to take Foundayo and half took a placebo, a dummy pill, and neither patients nor researchers knew who got which.

People in the trials started out with about 51 to 58 breathing interruptions an hour.  After 52 weeks, those taking Foundayo had about 17 to 18 fewer an hour, compared with about 5 fewer on placebo, the JAMA paper reports.  Lilly says about 32% of Foundayo users who did not use a breathing machine reached remission or mild disease, meaning fewer than 15 events an hour without heavy daytime sleepiness.  Foundayo users also lost about 10% to 11% of their body weight, compared with 1% to 2% on placebo, and had larger drops in blood pressure and in a blood marker of inflammation, the heart association says.

Side effects and limits

Stomach and intestinal problems such as nausea, diarrhea and constipation were the most common side effects and were mostly mild to moderate.  In the JAMA paper, about 68% to 71% of Foundayo users reported such problems, compared with about 37% on placebo.  About 12% of Foundayo users in the first study and about 7% in the second quit because of side effects, compared with 4% or fewer on placebo, Lilly says.  The trials did not include people with diabetes, and they measured breathing and risk factors rather than heart attacks or strokes.

“In ATTAIN-OSA, Foundayo significantly reduced breathing interruptions and drops in oxygen during sleep,” said Dr. Vaishnavi Kundel, a sleep medicine specialist at the Icahn School of Medicine at Mount Sinai in New York, in Lilly’s announcement.  The trials were part of Lilly’s own testing program.

What it means for readers

Lilly’s injectable Zepbound is already FDA-approved to treat moderate-to-severe sleep apnea in adults with obesity.  Lilly did not say what the pill would cost for sleep apnea.  The American Heart Association counts healthy sleep among its eight measures of heart health and recommends screening for sleep apnea in people with certain heart conditions, according to Lilly.  Because most people with sleep apnea have never been diagnosed, Lilly says, anyone with concerns can ask a doctor about a sleep study.

Source:  Eli Lilly announcement, Nov. 9, 2026, American Heart Association news release, Nov. 9, 2026 and ATTAIN-OSA results in JAMA, Nov. 9, 2026.