Eloralintide for weight loss in adults with obesity or overweight without type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial randomizes adults with obesity or overweight to receive eloralintide or placebo and follows them through a main phase of about 75 weeks, with an optional 2-year extension for participants with prediabetes. Eligible participants must have a BMI of at least 30 kg/m2 or at least 27 kg/m2 with a weight-related condition, be free of type 1 or type 2 diabetes, have stable weight for 90 days, and a history of unsuccessful dietary attempts. Key exclusions include prior or planned bariatric surgery or recent device-based obesity therapy, and recent major cardiovascular events such as heart attack or stroke. Study outcomes will compare weight change and safety events between the eloralintide and placebo groups.

Why it matters

Who can join: the full rules

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

Where it's running

• MFA Clinical Research
  Tuscaloosa, Alabama, United States Recruiting
• Headlands Research - Scottsdale
  Scottsdale, Arizona, United States Recruiting
• Neighborhood Healthcare Institute of Health
  Escondido, California, United States Recruiting
• Ark Clinical Research - Fountain Valley
  Fountain Valley, California, United States Recruiting
• Desert Oasis Healthcare Medical Group
  Palm Springs, California, United States Recruiting
• Peninsula Research Associates
  Rolling Hills Estates, California, United States Recruiting

+108 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.