Eloralintide for weight loss in adults with overweight or obesity and 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, and Type 2 Diabetes
This study will test whether eloralintide helps adults with overweight or obesity and type 2 diabetes lose more weight than a placebo over about 75 weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1035 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 159 sites (Birmingham, Alabama and 158 other locations) |
| Trial ID | NCT07282600 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional study gives participants either eloralintide or a matching placebo and follows them for roughly 75 weeks to measure body weight change and safety outcomes. Eligible participants must have type 2 diabetes, be on a stable diabetes treatment for at least 90 days, have a BMI of 27 kg/m2 or higher, and have stable weight in the prior 90 days. People who recently used GLP-1/GIP agents, amylin analogs, or insulin, or who had recent major cardiovascular events, are excluded, as are those with recent or planned surgical/device obesity interventions. The primary focus is on body weight reduction with concurrent monitoring of diabetes control and adverse events.
Who should consider this trial
Good fit: Adults with type 2 diabetes who have had stable diabetes treatment for ≥90 days, a BMI ≥27 kg/m2, and stable body weight for the prior 90 days, who are not using GLP-1/GIP agents, amylin analogs, or insulin and who have no recent major cardiovascular events, are the ideal candidates.
Not a fit: People with type 1 diabetes, recent heart attack or stroke, recent use of excluded antihyperglycemic drugs (GLP-1/GIP agents, amylin analogs, or insulin), or recent/planned bariatric or device-based obesity procedures are unlikely to qualify or benefit from this study.
Why it matters
Potential benefit: If successful, eloralintide could help people with overweight or obesity and type 2 diabetes achieve clinically meaningful weight loss and potentially improve blood sugar control.
How similar studies have performed: Other agents targeting incretin and related pathways (for example GLP-1 and dual GIP/GLP-1 drugs) have produced substantial weight loss in people with type 2 diabetes, but eloralintide itself is currently being tested in Phase 3 to confirm efficacy and safety.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have type 2 diabetes * Are on stable treatment for type 2 diabetes for at least 90 days prior to screening * Have a BMI ≥ 27 kg/m2 * Have a stable body weight (\<5% body weight change) for 90 days prior to screening 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 * Have taken any of the following antihyperglycemic medications within 90 days before screening: * amylin analogs * glucagon-like peptide-1 (GLP-1) receptor agonists * glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or * 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 * Have taken medications or alternative remedies intended for weight loss within 90 days of screening
Where this trial is running
Birmingham, Alabama and 158 other locations
- Birmingham Clinical Research — Birmingham, Alabama, United States (Recruiting)
- Cullman Clinical Trials — Cullman, Alabama, United States (Recruiting)
- Tucson Clinical Research Institute — Tucson, Arizona, United States (Recruiting)
- San Fernando Valley Health Institute — Canoga Park, California, United States (Recruiting)
- AMCR Institute — Escondido, California, United States (Recruiting)
- NorCal Medical Research, Inc — Greenbrae, California, United States (Recruiting)
- Inglewood Clinical — Inglewood, California, United States (Recruiting)
- Ark Clinical Research — Long Beach, California, United States (Recruiting)
- Pacific Clinical Studies — Los Alamitos, California, United States (Recruiting)
- Care Access - Santa Clarita — Santa Clarita, California, United States (Recruiting)
- Encompass Clinical Research — Spring Valley, California, United States (Recruiting)
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States (Recruiting)
- Care Access - Aurora — Aurora, Colorado, United States (Recruiting)
- New England Research Associates, LLC — Bridgeport, Connecticut, United States (Recruiting)
- CMR of Greater New Haven, LLC — Hamden, Connecticut, United States (Recruiting)
- Arrow Clinical Trials — Daytona Beach, Florida, United States (Recruiting)
- Care Access - Delray Beach — Delray Beach, Florida, United States (Recruiting)
- Fleming Island Center for Clinical Research — Fleming Island, Florida, United States (Recruiting)
- Nature Coast Clinical Research - Inverness — Inverness, Florida, United States (Recruiting)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (Recruiting)
- Flourish Research Acquisition, LLC dba Flourish Research - North Miami — Miami, Florida, United States (Recruiting)
- New Horizon Research 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)
- Clinical Site Partners, LLC dba Flourish Research — Winter Park, Florida, United States (Recruiting)
- Teak Research Consults - Dunwoody — Dunwoody, Georgia, United States (Recruiting)
- Teak Research Consults — Lawrenceville, Georgia, United States (Recruiting)
- The Jones Center Clinical Research — Macon, Georgia, United States (Recruiting)
- Pacific Diabetes & Endocrine Center — Honolulu, Hawaii, United States (Recruiting)
- NorthShore University Health System — Skokie, Illinois, United States (Recruiting)
- DM Clinical Research - Indianapolis — Indianapolis, Indiana, United States (Recruiting)
- Clinical Trials Management, LLC d/b/a Flourish Research — Metairie, Louisiana, United States (Recruiting)
- IMA Clinical Research Monroe - Armand — Monroe, Louisiana, United States (Recruiting)
- Centennial Medical Group — Columbia, Maryland, United States (Recruiting)
- Lucida Clinical Trials — New Bedford, Massachusetts, United States (Recruiting)
- Clinical Research Professionals — Chesterfield, Missouri, United States (Recruiting)
- Clinvest Headlands Llc — Springfield, Missouri, United States (Recruiting)
- Hypertension & Nephrology Association — Eatontown, New Jersey, United States (Recruiting)
- IMA Clinical Research Warren — Warren Township, New Jersey, United States (Recruiting)
- Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States (Recruiting)
- NYC Research INC — Long Island City, New York, United States (Recruiting)
- PharmQuest Life Sciences, LLC — Greensboro, North Carolina, United States (Recruiting)
- West Clinical Research — Morehead City, North Carolina, United States (Recruiting)
- Trial Management Associates - Wilmington - Floral Parkway — Wilmington, North Carolina, United States (Recruiting)
- Lillestol Research — Fargo, North Dakota, United States (Recruiting)
- Care Access - Lima — Lima, Ohio, United States (Recruiting)
- Summit Headlands — Portland, Oregon, United States (Recruiting)
- Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair — Pittsburgh, Pennsylvania, United States (Recruiting)
- Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States (Recruiting)
- Accellacare - Mt Pleasant — Mt. Pleasant, South Carolina, United States (Recruiting)
+109 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 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.