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
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1980 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 173 sites (Tuscaloosa, Alabama and 172 other locations) |
| Trial ID | NCT07321886 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
- 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)
- Care Access - Sacramento — Sacramento, California, United States (Recruiting)
- Southern California Clinical Research — Santa Ana, California, United States (Recruiting)
- University Clinical Investigators, Inc. — Tustin, California, United States (Recruiting)
- Chase Medical Research, LLC — Waterbury, Connecticut, United States (Recruiting)
- JEM Research Institute — Atlantis, Florida, United States (Recruiting)
- BioMed Research & Medical Center — Miami, Florida, United States (Recruiting)
- Adult Medicine of Lake County, Inc. — Mt. Dora, Florida, United States (Recruiting)
- American Research Centers of Florida — Pembroke Pines, Florida, United States (Recruiting)
- AHF Pensacola — Pensacola, Florida, United States (Recruiting)
- IMA Clinical Research St. Petersburg — St. Petersburg, Florida, United States (Recruiting)
- Teak Research Consults - Dunwoody — Dunwoody, Georgia, United States (Recruiting)
- Teak Research Consults — Lawrenceville, Georgia, United States (Recruiting)
- Clinical Research Atlanta — Stockbridge, Georgia, United States (Recruiting)
- East-West Medical Research Institute — Honolulu, Hawaii, United States (Recruiting)
- Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States (Recruiting)
- Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States (Recruiting)
- Care Access - Lake Charles (Bayou Pines) — Lake Charles, Louisiana, United States (Recruiting)
- MedStar Good Samaritan Hospital — Baltimore, Maryland, United States (Recruiting)
- MedStar Health Research Institute (MedStar Physician Based Research Network) — Hyattsville, Maryland, United States (Recruiting)
- Care Access - Quincy — Quincy, Massachusetts, United States (Recruiting)
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States (Recruiting)
- AMR Clinical — Las Vegas, Nevada, United States (Not_yet_recruiting)
- IMA Clinical Research Warren — Warren Township, New Jersey, United States (Recruiting)
- Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States (Recruiting)
- Rochester Clinical Research, LLC — Rochester, New York, United States (Recruiting)
- Monroe Biomedical Research — Monroe, North Carolina, United States (Recruiting)
- Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States (Recruiting)
- Tribe Clinical Research, LLC — Greenville, South Carolina, United States (Recruiting)
- Accellacare - Mt Pleasant — Mt. Pleasant, South Carolina, United States (Recruiting)
- AMR Clinical — Nashville, Tennessee, United States (Recruiting)
- The University of Texas Health Science Center at Houston — Bellaire, Texas, United States (Recruiting)
- Velocity Clinical Research, Dallas — Dallas, Texas, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- IMA Clinical Research San Antonio — San Antonio, Texas, United States (Recruiting)
- AMR Clinical — Norfolk, Virginia, United States (Recruiting)
- CONEXA Investigacion Clinica S.A. — Buenos Aires, Argentina (Not_yet_recruiting)
- Ciprec — Buenos Aires, Argentina (Not_yet_recruiting)
- Cicemo Srl — Buenos Aires, Argentina (Not_yet_recruiting)
- Cardiología Palermo — Buenos Aires, Argentina (Not_yet_recruiting)
- Glenny Corp. S.A. — Buenos Aires, Argentina (Not_yet_recruiting)
- CARDIAMET Investigaciones Médicas — Buenos Aires, Argentina (Not_yet_recruiting)
- Centro Médico Viamonte — Buenos Aires, Argentina (Not_yet_recruiting)
- Fundación Respirar — Buenos Aires, Argentina (Not_yet_recruiting)
- Cedic — Caba, Argentina (Not_yet_recruiting)
+123 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.