Eli Lilly Announces Positive Phase 2 Results for Eloralintide, a Selective Amylin Receptor Agonist, in Adults with Obesity or Overweight
Eli Lilly
Global Pharmaceutical R&D and Production Company
Based on these trial results, Eli Lilly will initiate patient enrollment for the Phase 3 clinical study of eloralintide for obesity treatment next month.
Eli Lilly and Company announced positive results from the Phase 2 clinical trial of eloralintide, an investigational selective amylin receptor agonist administered once weekly. The study evaluated the safety and efficacy of eloralintide in 263 obese or overweight adult participants without type 2 diabetes but with at least one weight-related comorbidity. At week 48, all dose groups of eloralintide met the primary endpoint, with average weight reductions ranging from 9.5% to 20.1%, compared to a 0.4% average reduction in the placebo group (using the efficacy estimand).1 The study results were presented at the 2025 Obesity Week conference and simultaneously published in The Lancet.
Statement:
1. Eloralintide is an investigational drug and has not been approved in China.
2. Eli Lilly does not recommend the use of any unapproved drugs/indications.
Liana K. Billings, M.D., Director of Clinical and Genetic Research in Diabetes and Cardiovascular Metabolic Diseases at Endeavor Health, Skokie, Illinois, and the first author of the studyRepresentation
Obesity is a complex disease, and no single treatment is effective for everyone. To truly meet the needs of personalized treatment, we require therapies with different mechanisms of action, allowing each patient to find the most suitable balance between efficacy and tolerability. The Phase 2 study data show that eloralintide has the potential to demonstrate good tolerability without compromising effectiveness, highlighting the promise of amylin receptor agonists in expanding treatment options and better serving patients with obesity.
In the study, all dose groups of eloralintide showed clinically meaningful improvements over placebo in secondary endpoints such as weight reduction and BMI improvement. Eloralintide was also associated with improvements in multiple cardiovascular risk factors, including waist circumference, blood pressure, blood lipids, blood glucose control, and inflammatory markers.
Phase 2 Study Results
i Each endpoint assessment used effectiveness estimands without multiplicity correction.
The most common adverse events were mild to moderate gastrointestinal symptoms and fatigue, which were more common in the higher dose groups. With a more gradual dose escalation regimen, the incidence of these adverse events was lower, and in the 1mg and 3mg dose groups, the incidence was similar to that of the placebo group.
Dr. Kenneth Custer, Executive Vice President of Eli Lilly and Company, President of the Cardiovascular and Metabolic Health DivisionRepresentation
Eli Lilly is advancing the most comprehensive pipeline for obesity treatment in the industry, committed to delivering innovative therapies that meet the diverse needs and preferences of people with obesity. We believe molecular specificity is crucial in this class of drugs. These research data indicate that eloralintide, as a selective amylin receptor agonist, shows potential for robust efficacy and better tolerability, offering a promising alternative to incretin-based therapies. For patients with higher efficacy requirements, we also anticipate eloralintide serving as a complementary option. Based on the encouraging results from the Phase 2 study of eloralintide, we plan to initiate patient enrollment for Phase 3 clinical trials by the end of this year.
Eli Lilly plans to launch a Phase 3 clinical trial of eloralintide monotherapy for obesity treatment by the end of this year and is evaluating its potential as an adjunctive therapy to incretin-based treatments.
About Eloralintide
Eloralintide (LY3841136) is an investigational once-weekly, selective amylin receptor agonist.2,3Research shows that eloralintide may reduce calorie intake by affecting satiety. Eli Lilly and Company is currently conducting a Phase 2 study (NCT06603571) to evaluate the use of eloralintide alone or in combination with tirzepatide for weight management in adult participants with obesity or overweight who also have type 2 diabetes.
About the Study
This Phase 2 study (NCT06230523) is a 48-week randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of once-weekly eloralintide monotherapy compared to placebo in obese or overweight adult participants without type 2 diabetes but with at least one weight-related comorbidity. The study randomized 263 participants in the United States, allocated in a 2:1:1:1:2:1:2 ratio to the following groups: placebo, eloralintide 1mg, 3mg, 6mg, 9mg, or escalating dosing regimens of 6/9mg and 3/6/9mg, respectively.
The primary objective of this study is to demonstrate the superiority of eloralintide over placebo in terms of the percentage change in body weight from baseline at Week 48.
References
Lilly
About Eli Lilly and Company
Eli Lilly and Company is a pharmaceutical company dedicated to improving human health through scientific innovation and benefiting patients worldwide. As a leader in the healthcare industry, Eli Lilly and Company has nearly 150 years of history. Today, our medicines have helped tens of millions of people around the world. Harnessing the power of biotechnology, chemistry, and genomic medicine, our scientists are actively advancing new medical breakthroughs to address serious global health challenges. We are redefining therapies for diabetes and obesity, reducing the long-term impact of obesity on the body; supporting prevention and treatment efforts for Alzheimer's disease; providing solutions for a range of immune-mediated diseases that threaten human health; and transforming difficult-to-treat cancers into manageable conditions. Every step Eli Lilly and Company takes toward a healthier world is rooted in our belief in "making life better for millions of patients." This includes innovative clinical trials aimed at addressing multiple global challenges while ensuring the accessibility and affordability of medicines. For more information about Eli Lilly and Company, please visit: www.lilly.com.cn.
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