Actively Recruiting
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, and Type 2 Diabetes
Led by Eli Lilly and Company · Updated on 2026-06-04
1035
Participants Needed
159
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of eloralintide compared with placebo for reducing body weight in adults with overweight or obesity who also have type 2 diabetes. This Phase 3 study is designed as a randomized, double-blind, placebo-controlled trial sponsored by Eli Lilly and Company. The study aims to understand how well eloralintide works for weight loss and its effects on related health measures over a period of about 75 weeks. Participants will be randomly assigned to receive one of four doses of eloralintide or a placebo, all given as weekly subcutaneous injections. The treatment period lasts 64 weeks, during which participants will receive their assigned dose once weekly. The study compares different doses of eloralintide to placebo to assess its impact on body weight and other health outcomes. During the study, participants will undergo regular assessments including body weight, body fat, waist circumference, blood sugar control HbA1c, blood pressure, and various blood markers like triglycerides and insulin. Patient questionnaires will measure physical function and quality of life. Researchers will also monitor medication use and pharmacokinetics of eloralintide. Participation involves about 75 weeks including follow-up, with close monitoring for safety and treatment effects.
CONDITIONS
Brief Title
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have type 2 diabetes
- On stable treatment for type 2 diabetes for at least 90 days before screening
- Have a body mass index (BMI) of 27 kg/m2 or higher
- Have had stable body weight with less than 5% change for 90 days before screening
You will not qualify if you...
- Have had or plan to have surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if done more than 1 year before screening)
- Have had or plan to have endoscopic or device-based therapy for obesity (device removal must be more than 6 months before screening)
- Have type 1 diabetes
- Have taken amylin analogs, GLP-1 receptor agonists, GIP/GLP receptor agonists, or insulin within 90 days before screening
- Have had heart attack, stroke, coronary artery revascularization, unstable angina, or hospitalization for congestive heart failure within 90 days before screening
- Have New York Heart Association Class IV congestive heart failure
- Have taken medications or remedies for weight loss within 90 days before screening
Research Team
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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