Eloralintide for weight loss in adults with obesity or overweight without 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, Without Type 2 Diabetes

Phase 3 Interventional Eli Lilly and Company · NCT07321886

This trial tests whether eloralintide helps adults with obesity or overweight (who do not have type 2 diabetes) lose weight and is safe.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1980 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations173 sites (Tuscaloosa, Alabama and 172 other locations)
Trial IDNCT07321886 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults without type 2 diabetes who have BMI ≥30 kg/m2 (or ≥27 kg/m2 with a weight-related condition), stable weight for 90 days, and a history of unsuccessful dietary attempts are the intended participants.

Not a fit: People with type 1 or type 2 diabetes, recent heart attack/stroke/coronary events, or recent bariatric or device-based obesity procedures are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If effective, eloralintide could help people with obesity or overweight achieve clinically meaningful weight loss and improve related health measures like blood pressure and cholesterol.

How similar studies have performed: Other approved weight-loss medications, particularly GLP-1 receptor agonists, have shown substantial weight loss in similar populations, but eloralintide is a newer agent whose Phase 3 results are still being established.

Eligibility criteria

Show full inclusion / exclusion criteria
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 this trial is running

Tuscaloosa, Alabama and 172 other locations

+123 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions ObesityOverweight
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.