Foundayo (orforglipron) was Associated with Reduced Body Weight of Up To 13% in Adults 65 and Older with Obesity or Overweight, in New Analysis of ATTAIN-1/2

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

  • 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
  • Key results: Weight loss in adults 65 and olderFoundayo 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 groupsThe 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 analysisATTAIN-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.

    LimitationsThis 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.

    References1. 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)About LillyLilly 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.

    Cautionary Statement Regarding Forward-Looking StatementsThis 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 NamesAll 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.

    Source: Eli Lilly and Company

    Source: HealthDay

    Related articles

  • FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water Restrictions - April 1, 2026
  • Foundayo (orforglipron) FDA Approval History

    More news resources

  • FDA Medwatch Drug Alerts
  • Daily MedNews
  • News for Health Professionals
  • New Drug Approvals
  • New Drug Applications
  • Clinical Trial Results
  • Generic Drug Approvals
  • Drugs.com Podcast
  • Subscribe to our newsletter

    Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

    Read more

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords