RecruitingPhase 3NCT07282600
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes
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
Sponsor
Eli Lilly and Company
Enrollment
1,035 participants
Start Date
Dec 15, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Have type 2 diabetes
- Are on stable treatment for type 2 diabetes for at least 90 days prior to screening
- Have a BMI ≥ 27 kg/m2
- Have a stable body weight (\<5% body weight change) for 90 days prior to screening
Exclusion Criteria16
- Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \>1 year before screening)
- Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
- Have type 1 diabetes
- Have taken any of the following antihyperglycemic medications within 90 days before screening:
- amylin analogs
- glucagon-like peptide-1 (GLP-1) receptor agonists
- glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or
- insulin
- Have had within 90 days prior to screening:
- heart attack
- stroke
- coronary artery revascularization
- unstable angina, or
- hospitalization due to congestive heart failure
- Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
- Have taken medications or alternative remedies intended for weight loss within 90 days of screening
Interventions
DRUGEloralintide
Administered SC
DRUGPlacebo
Administered SC
Locations(158)
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NCT07282600
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