A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes
Recruiting · NCT07321886 · 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 purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
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
- 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 it is running
60 locations listed across 23 US states.
- MFA Clinical Research - Tuscaloosa, Alabama, United States
- MFA Clinical Research - Tuscaloosa, Alabama, United States
- Headlands Research - Scottsdale - Scottsdale, Arizona, United States
- Headlands Research - Scottsdale - Scottsdale, Arizona, United States
- Neighborhood Healthcare Institute of Health - Escondido, California, United States
- Neighborhood Healthcare Institute of Health - Escondido, California, United States
- Ark Clinical Research - Fountain Valley - Fountain Valley, California, United States
- Ark Clinical Research - Fountain Valley - Fountain Valley, California, United States
- Desert Oasis Healthcare Medical Group - Palm Springs, California, United States
- Desert Oasis Healthcare Medical Group - Palm Springs, 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
- 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
- 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
- BioMed Research & Medical Center - Miami, Florida, United States
- BioMed Research & Medical Center - Miami, Florida, United States
- Adult Medicine of Lake County, Inc. - Mt. Dora, Florida, United States
- Adult Medicine of Lake County, Inc. - Mt. Dora, Florida, United States
- American Research Centers of Florida - Pembroke Pines, Florida, United States
- American Research Centers of Florida - Pembroke Pines, Florida, United States
- AHF Pensacola - Pensacola, Florida, United States
- AHF Pensacola - Pensacola, Florida, United States
- IMA Clinical Research St. Petersburg - St. Petersburg, Florida, United States
- IMA Clinical Research St. Petersburg - St. Petersburg, Florida, United States
- Teak Research Consults - Dunwoody - Dunwoody, Georgia, United States
- Teak Research Consults - Dunwoody - Dunwoody, Georgia, United States
- Teak Research Consults - Lawrenceville, Georgia, United States
- Teak Research Consults - Lawrenceville, Georgia, United States
- Clinical Research Atlanta - Stockbridge, Georgia, United States
- Clinical Research Atlanta - Stockbridge, Georgia, United States
- East-West Medical Research Institute - Honolulu, Hawaii, United States
- East-West Medical Research Institute - Honolulu, Hawaii, 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 Clinical Research Center - Topeka, Kansas, United States
- Cotton O'Neil Clinical Research Center - Topeka, Kansas, United States
- Care Access - Lake Charles (Bayou Pines) - Lake Charles, Louisiana, United States
- Care Access - Lake Charles (Bayou Pines) - Lake Charles, Louisiana, United States
- MedStar Good Samaritan Hospital - Baltimore, Maryland, United States
- MedStar Good Samaritan Hospital - Baltimore, Maryland, United States
- MedStar Health Research Institute (MedStar Physician Based Research Network) - Hyattsville, Maryland, United States
- MedStar Health Research Institute (MedStar Physician Based Research Network) - Hyattsville, Maryland, United States
- Care Access - Quincy - Quincy, Massachusetts, United States
- Care Access - Quincy - Quincy, Massachusetts, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division - Troy, Michigan, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division - Troy, Michigan, United States
- AMR Clinical - Las Vegas, Nevada, United States
- AMR Clinical - Las Vegas, Nevada, United States
- IMA Clinical Research Warren - Warren Township, New Jersey, United States
- IMA Clinical Research Warren - Warren Township, New Jersey, United States
- Albuquerque Clinical Trials, Inc. - Albuquerque, New Mexico, United States
- Albuquerque Clinical Trials, Inc. - Albuquerque, New Mexico, United States
Showing 60 of 324 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →