Lilly's selective amylin agonist, eloralintide, demonstrated meaningful weight loss and favorable tolerability in a Phase 2 study of adults with obesity or overweight
Based on these trial results, Lilly will begin enrolling Phase 3 clinical studies for the treatment of obesity next month
INDIANAPOLIS, Nov. 6, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) today announced positive results from a Phase 2 trial evaluating the safety and efficacy of eloralintide, an investigational once-weekly, selective amylin receptor agonist, in 263 adults with obesity or overweight with at least one obesity-related comorbidity and without type 2 diabetes. At 48 weeks, all treatment arms of eloralintide met the primary endpoint, demonstrating superior mean weight reductions from 9.5% to 20.1% compared to 0.4% with placebo using the efficacy estimand.1 Results from the trial were presented at ObesityWeek 2025 and simultaneously published in The Lancet.
"Obesity is a complex condition, and no single treatment works for everyone. To truly address each patient's needs, we need therapies with different mechanisms of action so that each person can receive the treatment that offers the best balance of effectiveness and tolerability for them," said Liana K. Billings, M.D., Director of Clinical and Genetics Research in Diabetes and Cardiometabolic Disease at Endeavor Health, Skokie, Illinois, and lead author. "These Phase 2 data suggest eloralintide could offer a promising tolerability profile without compromising on efficacy, underscoring the potential of amylin receptor agonists to expand our therapeutic strategies and better serve individuals living with obesity."
In the trial, all doses of eloralintide delivered clinically meaningful improvements compared to placebo for the secondary endpoints of reductions in body weight and body mass index. Treatment with eloralintide was also associated with improvements across cardiometabolic risk factors including waist circumference, blood pressure, lipid profiles, glycemic control and markers of inflammation.
Phase 2 Results
Primary Endpoint: Mean percent change in body weight from avg. baseline of 109.1 kg (240.5 lbs)i | |
Eloralintide 1 mg | -9.5% (-10.2 kg; -22.5 lbs) |
Eloralintide 3 mg | -12.4% (-13.3 kg; -29.3 lbs) |
Eloralintide 6 mg | -17.6% (-18.7 kg; -41.2 lbs) |
Eloralintide 9 mg | -20.1% (-21.3 kg; -47.0 lbs) |
Eloralintide 6/9 mg | -19.9% (-21.0 kg; -46.3 lbs) |
Eloralintide 3/6/9 mg | -16.4% (-17.8 kg; -39.2 lbs) |
Placebo | -0.4% (-0.2 kg; -0.4 lbs) |
iEndpoints are assessed with the efficacy estimand and not adjusted for multiplicity. | |
The most common adverse events were mild to moderate gastrointestinal symptoms and fatigue, which were seen more frequently in the higher dose arms. The incidence of these adverse events were lower with slower dose escalation and were similar to placebo for the 1 mg and 3 mg arms.
"Lilly is advancing the most comprehensive pipeline of obesity medicines, with a commitment to deliver innovative treatments that reflect the diverse needs and preferences of people living with obesity. We believe that molecule specificity is important in this class," said Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health. "These data show that eloralintide, a selective amylin receptor agonist, offers the potential for strong efficacy with improved tolerability and could serve as an alternative to incretin therapies. We also are optimistic that it could be a complementary option for patients that need higher levels of efficacy. Based on the encouraging results from Phase 2 trials of eloralintide, we plan to begin Phase 3 enrollment by year-end."
Lilly plans to initiate Phase 3 clinical studies of eloralintide as a monotherapy for the treatment of obesity by the end of this year and is evaluating its use as a complementary treatment to incretin therapy.
About eloralintide
Eloralintide is an investigational once-weekly, selective amylin receptor agonist previously known as LY3841136.2,3 Eloralintide has the potential to decrease calorie intake, and the effects are likely mediated by affecting satiety, or the feeling of fullness. Lilly is also conducting a Phase 2 study (NCT06603571) evaluating eloralintide, alone or in combination, with tirzepatide for weight management in adults with obesity or overweight and type 2 diabetes.
About the study
The Phase 2 study (NCT06230523) was a 48-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of once-weekly eloralintide monotherapy with placebo in adults with obesity or overweight and at least one weight-related comorbidity and without type 2 diabetes. The trial randomized 263 participants across the U.S. in a 2:1:1:1:2:1:2 ratio to receive either placebo, 1 mg, 3 mg, 6 mg or 9 mg eloralintide, or an eloralintide dose escalation of 6/9 mg or 3/6/9 mg, respectively. The primary objective of the study was to demonstrate that eloralintide is superior to placebo in percent change in body weight from baseline at 48 weeks.
Endnotes and References
- The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) for 48 weeks.
- Briere DA, Long A, Bullock DM, et al. 849-P: Eloralintide (LY3841136), a Selective Amylin Mimetic, Lowered Body Weight with Improved Quality of Weight Loss and GI Tolerability in Rats Compared with Cagrilintide. Diabetes 2025;74 (Supplement_1):849-P. https://doi.org/10.2337/db25-849-P
- Bhattachar SN, Tham L-S, Tidemann-Miller B, et al. 882-P: Eloralintide, a Selective, Long-Acting Amylin Receptor Agonist for Obesity—Phase 1 Proof of Concept. Diabetes 2025;74. (Supplement_1):882-P. https://doi.org/10.2337/db25-882-P
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
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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 eloralintide as a potential treatment for adults with obesity or overweight, and the timeline for future clinical studies, presentations, and other milestones relating to eloralintide 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 planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that eloralintide will prove to be a safe and effective treatment for obesity or overweight, that eloralintide will receive regulatory approval, 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.
Refer to: Brooke Frost; [email protected]; 317-432-9145 (Media)
Michael Czapar; [email protected]; 317-617-0983 (Investors)
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