A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes
Phase 3 – large-scale trial before approval
Conditions:
Obesity
Overweight
Sponsor: Eli Lilly and Company
trial.available_in:
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Overview
The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase.
Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
Who can participate
Inclusion Criteria:
* Have Body Mass Index (BMI) at screening of the following:
* 30 kilogram per square meter (kg/m2) OR
* 27 kg/m2 with at least one of the following weight-related health conditions at screening:
* high blood pressure
* dyslipidemia
* obstructive sleep apnea, or
* heart disease
* Have a stable body weight (\<5% body weight change) for 90 days prior to screening.
* Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
Exclusion Criteria:
* 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 or type 2 diabetes
* 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
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