RECRUITINGPhase 3INTERVENTIONAL
A Study of Eloralintide (LY3841136) in Participants 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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Eloralintide
Administered SC
DRUG
Placebo
Administered SC
Locations (20)
MFA Clinical Research
Tuscaloosa, Alabama, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Care Access - Sacramento
Sacramento, California, United States
Southern California Clinical Research
Santa Ana, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
BioMed Research & Medical Center
Miami, Florida, United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, United States
American Research Centers of Florida
Pembroke Pines, Florida, United States
AHF Pensacola
Pensacola, Florida, United States
IMA Clinical Research St. Petersburg
St. Petersburg, Florida, United States
Teak Research Consults - Dunwoody
Dunwoody, Georgia, United States
Teak Research Consults
Lawrenceville, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States