Lilly's Foundayo (orforglipron) significantly reduced obstructive sleep apnea severity, reinforcing its potential to improve health beyond weight loss
Lilly's Foundayo (orforglipron) significantly reduced obstructive sleep apnea severity, reinforcing its potential to improve health beyond weight loss |
| [09-November-2026] |
In adults with moderate-to-severe OSA and obesity or overweight, Foundayo reduced breathing interruptions during sleep by up to an average of 44%, with up to 32% of participants achieving remission or mild disease Foundayo also reduced sleep apnea-specific hypoxic burden by up to an average of 55.9%, improving oxygen levels during sleep Lilly plans to submit Foundayo to the U.S. FDA for moderate-to-severe obstructive sleep apnea by the end of 2026 INDIANAPOLIS, Nov. 9, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), today announced positive results from ATTAIN-OSA, a Phase 3 clinical program evaluating the efficacy and safety of Foundayo (orforglipron) in adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity or overweight, with and without the use of positive airway pressure (PAP) therapy. At 52 weeks, Foundayo met the primary endpoint, significantly reducing the apnea-hypopnea index (AHI), the standard measure of sleep apnea severity, as well as improving weight and other cardiovascular risk factors.1 The results were presented today at the American Heart Association (AHA) Scientific Sessions 2026 and simultaneously published in JAMA. OSA affects an estimated 936 million adults worldwide, and most have never been diagnosed.2 In people with OSA, the airway repeatedly collapses during sleep, causing drops in oxygen and increases in blood pressure that are associated with hypertension, heart failure, atrial fibrillation, coronary artery disease and stroke.3,4 The AHA counts healthy sleep among its Life's Essential 8 measures of cardiovascular health and recommends screening for OSA in people with certain cardiovascular conditions, reflecting growing recognition that treating OSA is part of comprehensive cardiovascular care.3,5 Vaishnavi Kundel, M.D., M.S., Associate Professor of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Icahn School of Medicine at Mount Sinai: "We know there's a two-way relationship between sleep and cardiovascular health, and the repeated drops in oxygen that happen with obstructive sleep apnea can strain blood pressure and the heart over time. In ATTAIN-OSA, Foundayo significantly reduced breathing interruptions and drops in oxygen during sleep, while also improving blood pressure and inflammation. In addition to improving their sleep, what I care about for my patients is improving the cardiovascular risk factors that have the potential to impact long-term health." In participants not using PAP therapy, Foundayo reduced the number of AHI events by 21.1 per hour (43.8%) at 52 weeks from an average baseline of 50.7 events per hour. Notably, 47.2% of these participants achieved an AHI reduction of 50% or more, and 31.5% achieved remission or mild disease.6 In participants using PAP therapy, Foundayo reduced the number of AHI events by 18.3 per hour (27.5%) at 52 weeks from an average baseline of 57.6 events per hour. Of these participants, 33.7% achieved an AHI reduction of 50% or more, and 19.6% achieved remission or mild disease. Foundayo also reduced sleep apnea-specific hypoxic burden, a measure of how deeply and for how long oxygen levels fall during sleep, by 81.4 percent-minutes per hour (55.9%) in participants not using PAP therapy and by 75.0 percent-minutes per hour (45.8%) in those using PAP therapy. Alongside these improvements in OSA, participants taking Foundayo lost an average of 28.0 lbs (11.5%) and 28.2 lbs (11.2%), without and with PAP therapy, respectively. Foundayo also improved certain cardiovascular risk factors, lowering hsCRP, a marker of inflammation, by an average of 48.9% and 38.6%, and systolic blood pressure by an average of 8.6 mmHg and 7.3 mmHg, in participants not using and using PAP therapy, respectively.7 ATTAIN-OSA Efficacy Estimand Results8
Thomas Seck, M.D., Senior Vice President of Product Development of Lilly Cardiometabolic Health: "OSA is one of the most serious complications of obesity and is closely linked to cardiovascular disease. In ATTAIN-OSA, Foundayo significantly improved sleep apnea along with key cardiovascular risk factors, showing its potential to treat conditions that drive heart disease. 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." The overall safety and tolerability profile of Foundayo was generally consistent with previous trials in the ACHIEVE and ATTAIN programs. The most common adverse events were gastrointestinal, including nausea, diarrhea, constipation, dyspepsia and vomiting, and were generally mild to moderate in severity. Discontinuation rates due to adverse events with Foundayo vs. placebo were 12.2% vs. 3.8% among participants not using PAP therapy and 6.8% vs. 0.6% among those using PAP therapy. Lilly plans to submit Foundayo to the U.S. FDA for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity or overweight by the end of 2026. Frequently Asked Questions 1. What is Foundayo (orforglipron)? Foundayo is a once-daily oral small molecule GLP-1 receptor agonist that can be taken any time of day without fasting or water restrictions. It is approved in the U.S. for adults with obesity and in multiple countries around the world for adults with obesity and type 2 diabetes. Lilly plans to submit Foundayo to the U.S. Food and Drug Administration for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity or overweight by the end of 2026, with other global submissions to follow. 2. What are the results for Foundayo in obstructive sleep apnea? In ATTAIN-OSA, Foundayo significantly reduced sleep apnea severity in adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity or overweight, with benefits seen in participants with and without positive airway pressure (PAP) therapy. At 52 weeks, Foundayo reduced the apnea-hypopnea index (AHI) by 43.8% in participants not using PAP therapy and 27.5% in those using PAP therapy. Notably, 31.5% of the participants taking Foundayo and not using PAP therapy met criteria for remission or mild OSA. Foundayo also reduced sleep apnea-specific hypoxic burden, body weight and hsCRP, a marker of inflammation. The safety profile was generally consistent with previous trials. 3. Can GLP-1 medicines help treat obstructive sleep apnea? Incretin-based medicines are changing how obstructive sleep apnea can be treated in adults with obesity. Zepbound, approved for moderate-to-severe OSA in adults with obesity, along with Foundayo and retatrutide, which were studied for OSA, have significantly reduced sleep apnea severity, weight and certain other cardiovascular risk factors in Phase 3 trials. Together, these medicines reflect Lilly's commitment to developing treatment options that address the different needs, risk factors and preferences of people living with cardiometabolic disease. 4. How is obstructive sleep apnea connected to cardiovascular disease? OSA is closely linked to cardiovascular disease. In people with OSA, the airway repeatedly collapses during sleep, causing drops in oxygen and rises in blood pressure that are associated with hypertension, heart failure, atrial fibrillation, coronary artery disease and stroke.3,4 The American Heart Association recommends screening for OSA in people with certain cardiovascular conditions and counts healthy sleep among its Life's Essential 8 measures of cardiovascular health.3,5 5. Can treating obstructive sleep apnea help address cardiovascular risk? Treating obstructive sleep apnea is increasingly recognized as part of addressing cardiovascular risk because OSA is closely linked to conditions like high blood pressure. Treating OSA has been shown to lower blood pressure.4 In ATTAIN-OSA, Foundayo improved sleep apnea along with certain cardiovascular risk factors, including systolic blood pressure and inflammation, as measured by hsCRP.7 While this study was designed to primarily assess Foundayo in OSA, ATTAIN-Hypertension is an ongoing Phase 3 study to assess the impact on high blood pressure. 6. How is obstructive sleep apnea severity measured, and what is remission? Obstructive sleep apnea severity is measured with the apnea-hypopnea index (AHI), the number of times per hour that breathing stops or becomes shallow during sleep. An AHI of 15 to 29 events per hour is considered moderate, and 30 or more is considered severe.9 In ATTAIN-OSA, OSA remission was defined as AHI below 5 events per hour and mild OSA was defined as an AHI of 5 to under 15 events per hour without excessive daytime sleepiness, measured as an Epworth Sleepiness Scale score of 10 or less. 7. What is sleep apnea-specific hypoxic burden, and why does it matter? Sleep apnea-specific hypoxic burden measures how deeply and for how long oxygen levels fall during breathing interruptions in sleep. While AHI counts how often breathing is disrupted, hypoxic burden captures how much oxygen the body loses as a result, and repeated drops in oxygen during sleep are associated with cardiovascular disease.10 In ATTAIN-OSA, Foundayo reduced hypoxic burden by an average of 55.9% in participants not using PAP therapy and 45.8% in those using PAP therapy. About Foundayo About ATTAIN-OSA Endnotes and References
FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS
Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
Foundayo may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery. Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo. Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures. Common side effects Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. Before taking Foundayo
Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? How to take
Learn more This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you. OG CON BS APR2026 Foundayo™ is a trademark of Eli Lilly and Company. ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:
Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
KwikPen®: Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them. Zepbound may cause serious side effects, including: Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back. Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures. Common side effects Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. Before using Zepbound
Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
How to take
Learn more This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you. ZP CON BS 01SEP2026 About Lilly Cautionary Statement Regarding Forward-Looking Statements Trademarks and Trade Names
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