Foundayo (orforglipron), a once-daily pill taken without food or water restrictions, was associated with reduced body weight by up to 13% in adults 65 and older with obesity or[...]

Once-daily oral Foundayo was associated with statistically significant body weight reductions vs. placebo in adults ≥65 years at all three doses studied at 72 weeks (p<0.001 for all)

In adults ≥65 without type 2 diabetes (ATTAIN-1), Foundayo at the highest approved dose (17.2 mg) was associated with 13% mean body weight reduction vs. 1.6% with placebo at 72 weeks (p<0.001)

Results were consistent across both age groups (<65 and ≥65 years), with and without type 2 diabetes, supporting Foundayo as a treatment option across a broad adult population

Starting July 1, 2026, Medicare beneficiaries can access Foundayo through Medicare GLP-1 Bridge at a $50 monthly copay

INDIANAPOLIS, May 22, 2026 - Eli Lilly and Company (NYSE: LLY) announced a new analysis from the Phase 3 ATTAIN-1 and ATTAIN-2 trials showing that Foundayo (orforglipron), was associated with clinically significant body weight reductions in adults aged 65 and older with obesity or overweight, with or without type 2 diabetes. Foundayo is the only approved GLP-1 pill that can be taken any time of day without food or water restrictions. The post-hoc analysis was recently presented at ECO 2026 in Istanbul, Turkey.1

Key results: Weight loss in adults 65 and older
Foundayo at all doses tested was associated with statistically significant reductions in body weight compared with placebo at 72 weeks in adults ≥65, in both trials using the efficacy estimand (all p<0.001).2

ATTAIN-1 (participants with obesity or overweight and without T2D): At the highest dose, mean body weight reduction reached 13% in the observed data for adults 65 and older. Participants ≥65 years were associated with mean body weight reductions of -7.9% (5.5 mg), -11.3% (9 mg), and -13.0% (17.2 mg) vs. -1.6% with placebo. Comparable mean body weight reductions of -7.7% (5.5 mg), -9.2% (9 mg), and -12.4% (17.2 mg) were observed in adults <65 vs. -0.8% placebo.

ATTAIN-2 (participants with obesity or overweight and T2D): Participants ≥65 years were associated with mean body weight reductions of -7.5% (5.5 mg), -8.3% (9 mg), and -12.2% (17.2 mg) vs. -2.3% placebo. Comparable mean body weight reductions of -5.0% (5.5 mg), -7.6% (9 mg), and -9.9% (17.2 mg) were observed in adults <65 vs. -2.2% placebo.

Expert perspective: What the results could mean for patients
"Weight management in older adults requires careful consideration of both benefit and risk. These data are reassuring on both fronts -up to 13% weight loss was observed in patients 65 and older taking Foundayo, with a safety profile similar to what was observed in the broader trial populations," said Rachel Batterham, M.D., senior vice president of medical innovation and external engagement, Lilly Cardiometabolic Health. "The fact that these results were achieved with a once-daily pill that patients can take at any time, without planning around meals or dealing with injections, matters in this age group."

Key results: Safety profile across age groups
The safety profile of orforglipron was generally consistent across age groups and aligned with the overall ATTAIN-1 and ATTAIN-2 populations. Gastrointestinal adverse events, sometimes severe, including nausea, constipation, diarrhea, and vomiting were the most frequently reported events, consistent with the GLP-1 receptor agonist class.

Pooled serious adverse events (SAEs) were reported by 5.6%, 6.2%, and 5.4% of participants <65 years of age and 9.9%, 13.0%, and 11.6% of participants ≥65 years of age in the orforglipron 5.5 mg, 9 mg, and 17.2 mg groups, respectively, vs. 5.4% and 11.4% in the placebo group.

What is Foundayo (orforglipron)
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) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, Foundayo 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 the ATTAIN trials and this analysis
ATTAIN-1 (NCT05869903) was a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial that enrolled 3,127 adults (195 were ≥65) with obesity or overweight (BMI ≥27 kg/m²) without pre-existing T2D across multiple countries.3 ATTAIN-2 (NCT05872620) was a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial enrolling 1,613 adults (418 were ≥65) with obesity or overweight and T2D. In both trials, participants received one of three once-daily doses of orforglipron (5.5 mg, 9 mg, or 17.2 mg) or placebo, alongside healthy diet and physical activity guidance.4

This post hoc analysis examined efficacy and safety outcomes in subgroups of participants aged <65 and ≥65 years. Efficacy outcomes were analyzed separately for each study; safety data were pooled. The primary endpoint was percent change in body weight from baseline at Week 72.

Limitations
This is a post-hoc, exploratory analysis of data from the ATTAIN-1 and ATTAIN-2 trials. Results are not pre-specified and should be considered hypothesis-generating. The subgroups analyzed (≥65 and <65 years) reflect the distribution of participants enrolled in the trials; the number of participants ≥65 is smaller than the <65 subgroup, and formal comparisons between age groups were not pre-specified. These findings will need to be confirmed in dedicated prospective analyses.

References
1. Horn DB, et al. Orforglipron for Obesity Treatment in Older Patients ≥65 Years With or Without Type 2 Diabetes. Poster LBP4.170 presented at: 33rd European Congress on Obesity (ECO 2026); May 12-15, 2026; Istanbul, Türkiye.
2. The ATTAIN-1 and ATTAIN-2 trials randomized participants to receive either Foundayo 5.5 mg, 14.5 mg, 17.2 mg or placebo. The trials were conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets, which are approved in the United States.
3. Wharton S, et al. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment. N Engl J Med. 2025;393(18):1796-806.
4. Horn DB, et al. Lancet. 2026;406:2927-2944.
5. Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. https://doi.org/10.1073/pnas.2014879117(2020)

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

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 nearly 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 treatment for older adults with obesity or overweight with or without type 2 diabetes, potential efficacy and tolerability of Foundayo, and the timeline for future readouts, presentations, and other milestones relating to Foundayo and its clinical trials 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 future study results will be consistent with the results to date, or that Foundayo will prove to be a safe and effective treatment for all populations and settings studied. 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.

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