Lilly's Foundayo (orforglipron) significantly reduced obstructive sleep apnea severity, reinforcing its potential to improve health beyond weight loss
Idag, 15:30
Lilly's Foundayo (orforglipron) significantly reduced obstructive sleep apnea severity, reinforcing its potential to improve health beyond weight loss
PR Newswire
INDIANAPOLIS, Nov. 9, 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 Results 8
Study 1: Participants Not Using
PAP Therapy | Study 2: Participants Using PAP
Therapy | |||
Foundayo | Placebo | Foundayo | Placebo | |
Primary Endpoint | ||||
Change in AHI events
per hour from avg. baseline of 50.7/57.6 events per hour | -21.1 events per
hour | -4.3 events per
hour | -18.3 events
per hour | -5.5 events per
hour |
Key Secondary Endpoints | ||||
Percent change in
AHI events per hour from avg. baseline of 50.7/57.6 events per hour | -43.8 % | -6.3 % | -27.5 % | -3.0 % |
Change in sleep
apnea-specific hypoxic burden from baseline geometric mean of 141.9/165.1 percent-minutes per hour | -81.4 percent-
minutes per hour (-55.9%) | -26.7 percent-
minutes per hour (-18.3%) | -75.0 percent-
minutes per hour (-45.8%) | -27.9 percent-
minutes per hour (-17.0%) |
Percent change in
body weight from avg. baseline of 110.2/114.6 kg (242.9/252.6 lbs) | -11.5% (-12.7 kg;
-28.0 lbs) | -1.8% (-2.0 kg;
-4.4 lbs) | -11.2% (-12.8 kg;
-28.2 lbs) | -0.9% (-1.0 kg;
-2.2 lbs) |
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
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) glucagon-like peptide-1 receptor agonist pill that can be taken any time of the day without restrictions on food and water intake. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.
About ATTAIN-OSA
ATTAIN-OSA (NCT06649045) is a Phase 3, 52-week, randomized, multicenter, double-blind, placebo-controlled trial investigating the efficacy and safety of Foundayo maximum tolerated dose (MTD) once daily versus placebo in participants who had moderate-to-severe obstructive sleep apnea (OSA) and obesity or overweight. The trial was comprised of two pivotal, independent studies (Study 1 and Study 2). Study 1 included 363 participants who were unable or unwilling to use PAP therapy; Study 2 included 349 participants who were on PAP therapy for at least 3 months at time of screening and continued PAP therapy during the study. In both studies, participants taking Foundayo started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to a maximum tolerated dose of 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg), 14.5 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, and 9 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg). The studies were conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets.
Endnotes and References
- All data in this press release represent the efficacy estimand.
- Benjafield AV, Ayas NT, Eastwood PR, et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respiratory Medicine. 2019;7(8):687-698.
- Yeghiazarians Y, Jneid H, Tietjens JR, et al. Obstructive sleep apnea and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2021;144(3):e56-e67.
- Ryan S. Intermittent hypoxia, cardiovascular disease and obstructive sleep apnoea. Journal of Thoracic Disease. 2018;10(Suppl 34):S4201-S4211.
- Lloyd-Jones DM, Allen NB, Anderson CAM, et al. Life's Essential 8: updating and enhancing the American Heart Association's construct of cardiovascular health: a presidential advisory from the American Heart Association. Circulation. 2022;146(5):e18-e43.
- OSA remission is defined as AHI <5 events per hour and mild OSA is defined as AHI ≥5 to <15 events per hour with an Epworth Sleepiness Scale score ≤10, indicating no excessive daytime sleepiness.
- All measures except for systolic blood pressure were controlled for family-wise type 1 error.
- The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) for 52 weeks without initiating PAP therapy (for participants not using PAP therapy at baseline), prohibited OSA surgery or procedures, or prohibited weight management treatments.
- American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
- Azarbarzin A, Sands SA, Stone KL, et al. The hypoxic burden of sleep apnoea predicts cardiovascular disease-related mortality. Eur Heart J. 2019;40(14):1149-1157.
FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
- Foundayo should not be used with other GLP-1 receptor agonist medicines.
- It is not known if Foundayo is safe and effective for use in children.
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.
- Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.
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
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.
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
- Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.
- Pregnancy Exposure Registry : There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
- If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.
- Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
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?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?
How to take
- Take Foundayo exactly as your healthcare provider tells you to.
- Use Foundayo with a reduced-calorie diet and increased physical activity.
- Take Foundayo by mouth 1 time each day, with or without food.
- Swallow tablets whole. Do not break, crush, or chew the tablet.
- If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.
- Do not take more than 1 tablet per day.
- If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.
- If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com .
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:
- obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
- moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.
- Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.
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.
- Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.
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
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss , and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.
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
- Your healthcare provider should show you how to use Zepbound before you use it for the first time.
- Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
- If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of 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?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.
- Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at MILEregistry@thermofisher.com or visit https://pregnancyregistry.lilly.com/zepbound .
How to take
- Read the Instructions for Use that come with Zepbound.
- Use Zepbound exactly as your healthcare provider says.
- Use Zepbound with a reduced-calorie diet and increased physical activity.
- Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).
- Use Zepbound 1 time each week, at any time of the day.
- Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
- If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
- Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.
Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com .
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
Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news , or follow us on Facebook , Instagram , and LinkedIn . P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo (orforglipron) as a potential treatment for adults with obstructive sleep apnea and obesity or overweight and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Refer to: | Niki Biro; niki_biro@lilly.com 317-358-9074 (Media) |
Michael Czapar; czapar_michael_c@lilly.com 317-617-0983 (Investors) |
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Lilly's Foundayo (orforglipron) significantly reduced obstructive sleep apnea severity, reinforcing its potential to improve health beyond weight loss
Idag, 15:30
Lilly's Foundayo (orforglipron) significantly reduced obstructive sleep apnea severity, reinforcing its potential to improve health beyond weight loss
PR Newswire
INDIANAPOLIS, Nov. 9, 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 Results 8
Study 1: Participants Not Using
PAP Therapy | Study 2: Participants Using PAP
Therapy | |||
Foundayo | Placebo | Foundayo | Placebo | |
Primary Endpoint | ||||
Change in AHI events
per hour from avg. baseline of 50.7/57.6 events per hour | -21.1 events per
hour | -4.3 events per
hour | -18.3 events
per hour | -5.5 events per
hour |
Key Secondary Endpoints | ||||
Percent change in
AHI events per hour from avg. baseline of 50.7/57.6 events per hour | -43.8 % | -6.3 % | -27.5 % | -3.0 % |
Change in sleep
apnea-specific hypoxic burden from baseline geometric mean of 141.9/165.1 percent-minutes per hour | -81.4 percent-
minutes per hour (-55.9%) | -26.7 percent-
minutes per hour (-18.3%) | -75.0 percent-
minutes per hour (-45.8%) | -27.9 percent-
minutes per hour (-17.0%) |
Percent change in
body weight from avg. baseline of 110.2/114.6 kg (242.9/252.6 lbs) | -11.5% (-12.7 kg;
-28.0 lbs) | -1.8% (-2.0 kg;
-4.4 lbs) | -11.2% (-12.8 kg;
-28.2 lbs) | -0.9% (-1.0 kg;
-2.2 lbs) |
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
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) glucagon-like peptide-1 receptor agonist pill that can be taken any time of the day without restrictions on food and water intake. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.
About ATTAIN-OSA
ATTAIN-OSA (NCT06649045) is a Phase 3, 52-week, randomized, multicenter, double-blind, placebo-controlled trial investigating the efficacy and safety of Foundayo maximum tolerated dose (MTD) once daily versus placebo in participants who had moderate-to-severe obstructive sleep apnea (OSA) and obesity or overweight. The trial was comprised of two pivotal, independent studies (Study 1 and Study 2). Study 1 included 363 participants who were unable or unwilling to use PAP therapy; Study 2 included 349 participants who were on PAP therapy for at least 3 months at time of screening and continued PAP therapy during the study. In both studies, participants taking Foundayo started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to a maximum tolerated dose of 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg), 14.5 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, and 9 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg). The studies were conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets.
Endnotes and References
- All data in this press release represent the efficacy estimand.
- Benjafield AV, Ayas NT, Eastwood PR, et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respiratory Medicine. 2019;7(8):687-698.
- Yeghiazarians Y, Jneid H, Tietjens JR, et al. Obstructive sleep apnea and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2021;144(3):e56-e67.
- Ryan S. Intermittent hypoxia, cardiovascular disease and obstructive sleep apnoea. Journal of Thoracic Disease. 2018;10(Suppl 34):S4201-S4211.
- Lloyd-Jones DM, Allen NB, Anderson CAM, et al. Life's Essential 8: updating and enhancing the American Heart Association's construct of cardiovascular health: a presidential advisory from the American Heart Association. Circulation. 2022;146(5):e18-e43.
- OSA remission is defined as AHI <5 events per hour and mild OSA is defined as AHI ≥5 to <15 events per hour with an Epworth Sleepiness Scale score ≤10, indicating no excessive daytime sleepiness.
- All measures except for systolic blood pressure were controlled for family-wise type 1 error.
- The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) for 52 weeks without initiating PAP therapy (for participants not using PAP therapy at baseline), prohibited OSA surgery or procedures, or prohibited weight management treatments.
- American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
- Azarbarzin A, Sands SA, Stone KL, et al. The hypoxic burden of sleep apnoea predicts cardiovascular disease-related mortality. Eur Heart J. 2019;40(14):1149-1157.
FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
- Foundayo should not be used with other GLP-1 receptor agonist medicines.
- It is not known if Foundayo is safe and effective for use in children.
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.
- Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.
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
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.
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
- Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.
- Pregnancy Exposure Registry : There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
- If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.
- Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
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?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?
How to take
- Take Foundayo exactly as your healthcare provider tells you to.
- Use Foundayo with a reduced-calorie diet and increased physical activity.
- Take Foundayo by mouth 1 time each day, with or without food.
- Swallow tablets whole. Do not break, crush, or chew the tablet.
- If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.
- Do not take more than 1 tablet per day.
- If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.
- If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com .
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:
- obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
- moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.
- Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.
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.
- Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.
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
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss , and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.
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
- Your healthcare provider should show you how to use Zepbound before you use it for the first time.
- Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
- If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of 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?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.
- Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at MILEregistry@thermofisher.com or visit https://pregnancyregistry.lilly.com/zepbound .
How to take
- Read the Instructions for Use that come with Zepbound.
- Use Zepbound exactly as your healthcare provider says.
- Use Zepbound with a reduced-calorie diet and increased physical activity.
- Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).
- Use Zepbound 1 time each week, at any time of the day.
- Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
- If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
- Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.
Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com .
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
Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news , or follow us on Facebook , Instagram , and LinkedIn . P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo (orforglipron) as a potential treatment for adults with obstructive sleep apnea and obesity or overweight and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Refer to: | Niki Biro; niki_biro@lilly.com 317-358-9074 (Media) |
Michael Czapar; czapar_michael_c@lilly.com 317-617-0983 (Investors) |
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SOURCE Eli Lilly and Company
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