Eloralintide for people with persistent obesity on weekly incretin therapy
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes
This trial will test whether adding eloralintide helps adults with persistent obesity or overweight who are already taking a weekly incretin medication, with or without type 2 diabetes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 178 sites (Birmingham, Alabama and 177 other locations) |
| Trial ID | NCT07392190 on ClinicalTrials.gov |
What this trial studies
Adults who remain overweight or obese despite stable weekly incretin therapy will receive either eloralintide or a matching placebo in addition to their background medication and will be followed for about 80 weeks. The study compares weight outcomes and safety between the eloralintide and placebo groups while participants maintain a stable incretin regimen. Eligibility focuses on BMI thresholds (≥30 kg/m2, or ≥27 kg/m2 with an obesity-related complication) and a stable body weight prior to enrollment. People with recent or planned surgical or device-based obesity treatments, type 1 diabetes, or recent disallowed antihyperglycemic medications are excluded.
Who should consider this trial
Good fit: Adults with persistent obesity or overweight (BMI ≥30 kg/m2, or ≥27 kg/m2 with an obesity-related complication) who are on stable weekly incretin therapy and have had less than 5% weight change recently are ideal candidates.
Not a fit: People with type 1 diabetes, recent or planned bariatric or device-based obesity procedures, or recent use of disallowed antihyperglycemic drugs are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, eloralintide could provide additional weight loss and improve obesity-related health measures when added to weekly incretin therapy.
How similar studies have performed: Other amylin receptor agonists, particularly when combined with GLP-1–based therapies, have shown promising weight-loss results in earlier-stage trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Are on stable incretin therapy at screening
* With persistent obesity or overweight defined as:
* ≥30 kg/m2 OR
* ≥27 kg/m2 with at least one existing obesity related complication at screening:
* hypertension
* dyslipidemia
* obstructive sleep apnea
* cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or
* type 2 diabetes
* Have a stable body weight (\<5% body weight change) at 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:
* dipeptidyl peptidase-4 (DPP-4) inhibitors
* amylin analogs
* 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
Where this trial is running
Birmingham, Alabama and 177 other locations
- Birmingham Clinical Research — Birmingham, Alabama, United States (Recruiting)
- RIO Clinical Trials - Phoenix — Phoenix, Arizona, United States (Recruiting)
- Headlands Research - Scottsdale — Scottsdale, Arizona, United States (Recruiting)
- Novak Clinical Research - Tucson - North La Cholla Boulevard — Tucson, Arizona, United States (Recruiting)
- Irvine Clinical Research — Irvine, California, United States (Recruiting)
- Scripps Whittier Diabetes Institute — La Jolla, California, United States (Not_yet_recruiting)
- Peninsula Research Associates — Rolling Hills Estates, California, United States (Recruiting)
- Care Access - Sacramento — Sacramento, California, United States (Recruiting)
- Artemis Institute for Clinical Research — San Diego, California, United States (Recruiting)
- Southern California Clinical Research — Santa Ana, California, United States (Recruiting)
- University Clinical Investigators, Inc. — Tustin, California, United States (Recruiting)
- New England Research Associates, LLC — Bridgeport, Connecticut, United States (Recruiting)
- Yale University School of Medicine — New Haven, Connecticut, United States (Not_yet_recruiting)
- Chase Medical Research, LLC — Waterbury, Connecticut, United States (Recruiting)
- JEM Research Institute — Atlantis, Florida, United States (Recruiting)
- AMR Clinical — Doral, Florida, United States (Recruiting)
- Northeast Research Institute (NERI) — Fleming Island, Florida, United States (Recruiting)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (Recruiting)
- New Horizon Research Center — Miami, Florida, United States (Recruiting)
- St Johns Center for Clinical Research — Saint Augustine, Florida, United States (Recruiting)
- Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States (Recruiting)
- Teak Research Consults - Dunwoody — Dunwoody, Georgia, United States (Recruiting)
- Center for Advanced Research & Education — Gainesville, Georgia, United States (Recruiting)
- Family First Medical Center — Idaho Falls, Idaho, United States (Recruiting)
- Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States (Recruiting)
- Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States (Recruiting)
- Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States (Recruiting)
- AMR Clinical — Lexington, Kentucky, United States (Recruiting)
- IMA Clinical Research Monroe - Armand — Monroe, Louisiana, United States (Recruiting)
- Centennial Medical Group — Columbia, Maryland, United States (Recruiting)
- Brigham and Women's Hospital Diabetes Program — Boston, Massachusetts, United States (Not_yet_recruiting)
- Great Lakes Research Institute — Southfield, Michigan, United States (Recruiting)
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States (Recruiting)
- Clinical Research Professionals — Chesterfield, Missouri, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Not_yet_recruiting)
- Weill Cornell Medical College — New York, New York, United States (Not_yet_recruiting)
- IMA Clinical Research Manhattan — New York, New York, United States (Recruiting)
- University of North Carolina Medical Center — Chapel Hill, North Carolina, United States (Recruiting)
- Medication Management — Greensboro, North Carolina, United States (Recruiting)
- Carteret Medical Group — Morehead City, North Carolina, United States (Recruiting)
- Accellacare - Wilmington - 1917 Tradd Court — Wilmington, North Carolina, United States (Recruiting)
- Care Access - Lima — Lima, Ohio, United States (Recruiting)
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) — Pittsburgh, Pennsylvania, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Juno Research — Houston, Texas, United States (Recruiting)
- Synergy Groups Medical LLC - Missouri City — Missouri City, Texas, United States (Recruiting)
- IMA Clinical Research San Antonio — San Antonio, Texas, United States (Recruiting)
- Endeavor Clinical Trials — San Antonio, Texas, United States (Recruiting)
- Consano Clinical Research, LLC — Shavano Park, Texas, United States (Recruiting)
- Texas Valley Clinical Research — Weslaco, Texas, United States (Recruiting)
+128 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.