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Recruiting
NCT07392190
A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin
Conditions: Overweight, Obesity
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 900
Sponsor: Eli Lilly and Company
Location: Birmingham Clinical Research Birmingham Alabama
Summary
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy.
Participation in the study will last about 80 weeks.
Eligibility Criteria
Inclusion Criteria:
* Are on stable incretin therapy at screening
* With persistent obesity or overweight defined as:
* ≥30 kg/m2 OR
* ≥27 kg/m2 with at least one existing obesity related complication at screening:
* hypertension
* dyslipidemia
* obstructive sleep apnea
* cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or
* type 2 diabetes
* 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 taken any of the following antihyperglycemic medications within 90 days before screening:
* dipeptidyl peptidase-4 (DPP-4) inhibitors
* amylin analogs
* 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
Source: ClinicalTrials.gov (NCT07392190). StuddyBuddy aggregates publicly available trial information.