Eli Lilly’s Foundayo obesity pill eases sleep apnea in late-stage trial, paving way for approval

Skip Navigation Markets Business Investing Tech Politics & Policy Video Watchlist Investing Club PRO Livestream Menu Key Points Eli Lilly said its new obesity pill, Foundayo, significantly reduced the severity of the most common sleep-related breathing disorder in a late-stage trial. The drugmaker plans to file by the end of the year for U.S. approval of the daily pill for moderate-to-severe obstructive sleep apnea in adults with obesity or who are overweight. The results make the pill one of several GLP-1 treatments to show promise in treating the condition. In this article LLY Follow your favorite stocks CREATE FREE ACCOUNT One of Eli Lilly's buildings in San Diego, California, Nov. 21, 2025. Mike Blake | Reuters Eli Lilly on Monday said its obesity pill Foundayo significantly reduced the severity of obstructive sleep apnea, the most common sleep-related breathing disorder, in patients with obesity, in a late-stage trial. The drugmaker plans to file by the end of the year for U.S. approval of the daily pill for moderate-to-severe obstructive sleep apnea, or OSA, in adults with obesity or who are overweight. The results make the pill — which rolled out in the U.S. in April — one of several GLP-1 treatments to show promise in treating the condition. OSA refers to interrupted breathing during sleep due to narrowed or blocked airways, which can cause drops in oxygen and increases in blood pressure that are associated with serious complications, such as hypertension, heart failure and stroke. The condition affects nearly 1 billion adults globally, including 80 million people ages 20 and over in the U.S., according to the National Council on Aging. Most have never been diagnosed, Lilly said in a release. Lilly's blockbuster weight loss injection Zepbound became the first medication to win U.S. approval for OSA in December 2024. Patients have limited treatment options outside of that drug and many use cumbersome machines that provide positive airway pressure, or PAP, to allow for normal breathing. "Foundayo is already making a difference for people living with obesity, and with plans to submit these results to the FDA by the end of the year, we could have the opportunity to help people living with OSA," Dr. Thomas Seck, senior vice president of product development of Lilly Cardiometabolic Health, said in a release. Lilly's sleep apnea trial results The trial tested Foundayo in two independent studies, the first of which included 363 patients who were unable or unwilling to use PAP therapy. The second study included 349 people who were on PAP therapy for at least three months at the time of screening and continued that treatment during the trial. Patients in both studies who took Foundayo started at a low dose and increased it gradually at four-week intervals to different maximum dosages. Researchers specifically examined how much the pill reduced the so-called apnea-hypopnea index , or AHI, which records the number of times per hour a person's breathing shows a restricted or completely blocked airway. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for the condition. People who took Foundayo and were not using PAP therapy had an average of 21.1 fewer AHI events per hour at 52 weeks, compared with an average reduction of 4.8 per hour for the placebo, according to the results. Foundayo also met the trial's second goal in that group, leading to an overall AHI reduction of 43.8% compared with a decrease of 6.3% for the placebo. Lilly said 31.5% of the participants in the Foundayo group met the criteria for remission or improvement to mild OSA. Meanwhile, patients who were on both Foundayo and PAP therapy had an average of 18.3 fewer AHI events per hour at 52 weeks, compared with an average reduction of 5.5 per hour for the placebo. Foundayo led to an overall AHI reduction of around 27.5% in that group, compared with a decrease of 3% for the placebo. The company said 19.6% of the participants on Foundayo and PAP therapy also met the criteria for remission or mild OSA. Foundayo also reduced what's known as the sleep apnea-specific hypoxic burden — a measure of how deeply and for how long oxygen levels fall during sleep. That metric fell by 55.9% in people not using PAP therapy and 45.8% in those using it. Lilly said the pill also helped patients lose roughly 11% of their weight across groups at 52 weeks and helped to lower a marker of inflammation. The company said the safety data and how well patients tolerated Foundayo were generally consistent with previous trials on the pill. Around 12% of people on Foundayo who were not using PAP therapy discontinued due to side effects, compared to 3.8% with the placebo. Meanwhile, 6.8% of those on both Lilly's pill and PAP discontinued the drug due to side effects, compared with 0.6% in the placebo group. The most common side effects were gastrointestinal, including nausea, diarrhea, constipation and vomiting, and were generally mild to moderate in severity. That's consistent with other GLP-1 medications. Choose CNBC as your preferred source on Google and never miss a moment from the most trusted name in business news.