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NCT07900633
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk
Conditions: Obesity, Overweight, Cardiovascular Diseases, Diabetes Mellitus, Type 2
Sex: All
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 3000
Sponsor: Eli Lilly and Company
Location: Central Research Associates Birmingham Alabama
Summary
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with a placebo in participants with obesity or overweight, type 2 diabetes, and increased cardiovascular risk.
Eligibility Criteria
Inclusion Criteria:
* Have type 2 diabetes
* Have a HbA1c value between ≥ 6.5% and ≤ 9.5% at screening
* Are on stable treatment with an unchanged dose of at least 1 and no more than 4 antihyperglycemic therapies for at least 90 days before screening
* Have an increased risk of cardiovascular events
* Have a BMI ≥ 25.0 kg/m2 at screening
* Have a stable body weight (\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 a history or diagnosis of New York Heart Association Functional Classification IV congestive heart failure
* Have had within 60 days prior to screening:
* acute myocardial infarction
* stroke
* hospitalization for congestive heart failure, or
* coronary, peripheral, or carotid artery revascularization procedure
* Have received treatment combining sulfonylurea and insulin within 90 days prior to screening
Source: ClinicalTrials.gov (NCT07900633). StuddyBuddy aggregates publicly available trial information.