A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin
Recruiting · NCT07392190 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
EloralintidePlacebo
What this trial is about
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
60 locations listed across 22 US states.
- Birmingham Clinical Research - Birmingham, Alabama, United States
- Birmingham Clinical Research - Birmingham, Alabama, United States
- RIO Clinical Trials - Phoenix - Phoenix, Arizona, United States
- RIO Clinical Trials - Phoenix - Phoenix, Arizona, United States
- Headlands Research - Scottsdale - Scottsdale, Arizona, United States
- Headlands Research - Scottsdale - Scottsdale, Arizona, United States
- Novak Clinical Research - Tucson - North La Cholla Boulevard - Tucson, Arizona, United States
- Novak Clinical Research - Tucson - North La Cholla Boulevard - Tucson, Arizona, United States
- Irvine Clinical Research - Irvine, California, United States
- Irvine Clinical Research - Irvine, California, United States
- Scripps Whittier Diabetes Institute - La Jolla, California, United States
- Scripps Whittier Diabetes Institute - La Jolla, California, United States
- EndoTrials Center for Clinical Research - La Mesa, California, United States
- EndoTrials Center for Clinical Research - La Mesa, California, United States
- Peninsula Research Associates - Rolling Hills Estates, California, United States
- Peninsula Research Associates - Rolling Hills Estates, California, United States
- Care Access - Sacramento - Sacramento, California, United States
- Care Access - Sacramento - Sacramento, California, United States
- Artemis Institute for Clinical Research - San Diego, California, United States
- Artemis Institute for Clinical Research - San Diego, California, United States
- Southern California Clinical Research - Santa Ana, California, United States
- Southern California Clinical Research - Santa Ana, California, United States
- University Clinical Investigators, Inc. - Tustin, California, United States
- University Clinical Investigators, Inc. - Tustin, California, United States
- New England Research Associates, LLC - Bridgeport, Connecticut, United States
- New England Research Associates, LLC - Bridgeport, Connecticut, United States
- Yale University School of Medicine - New Haven, Connecticut, United States
- Yale University School of Medicine - New Haven, Connecticut, United States
- Chase Medical Research, LLC - Waterbury, Connecticut, United States
- Chase Medical Research, LLC - Waterbury, Connecticut, United States
- JEM Research Institute - Atlantis, Florida, United States
- JEM Research Institute - Atlantis, Florida, United States
- AMR Clinical - Doral, Florida, United States
- AMR Clinical - Doral, Florida, United States
- Northeast Research Institute (NERI) - Fleming Island, Florida, United States
- Northeast Research Institute (NERI) - Fleming Island, Florida, United States
- Jacksonville Center for Clinical Research - Jacksonville, Florida, United States
- Jacksonville Center for Clinical Research - Jacksonville, Florida, United States
- New Horizon Research Center - Miami, Florida, United States
- New Horizon Research Center - Miami, Florida, United States
- St Johns Center for Clinical Research - Saint Augustine, Florida, United States
- St Johns Center for Clinical Research - Saint Augustine, Florida, United States
- Metabolic Research Institute, Inc. - West Palm Beach, Florida, United States
- Metabolic Research Institute, Inc. - West Palm Beach, Florida, United States
- Teak Research Consults - Dunwoody - Dunwoody, Georgia, United States
- Teak Research Consults - Dunwoody - Dunwoody, Georgia, United States
- Center for Advanced Research & Education - Gainesville, Georgia, United States
- Center for Advanced Research & Education - Gainesville, Georgia, United States
- Clinical Research Atlanta - Stockbridge, Georgia, United States
- Clinical Research Atlanta - Stockbridge, Georgia, United States
- Family First Medical Center - Idaho Falls, Idaho, United States
- Family First Medical Center - Idaho Falls, Idaho, United States
- Great Lakes Clinical Trials - Ravenswood - Chicago, Illinois, United States
- Great Lakes Clinical Trials - Ravenswood - Chicago, Illinois, United States
- Iowa Diabetes and Endocrinology Research Center - West Des Moines, Iowa, United States
- Iowa Diabetes and Endocrinology Research Center - West Des Moines, Iowa, United States
- Cotton O'Neil Diabetes & Endocrinology - Topeka, Kansas, United States
- Cotton O'Neil Diabetes & Endocrinology - Topeka, Kansas, United States
- AMR Clinical - Lexington, Kentucky, United States
- AMR Clinical - Lexington, Kentucky, United States
Showing 60 of 374 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →