Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Eloralintide Dose 1 		Participants will receive eloralintide subcutaneously (SC)
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Experimental
Eloralintide Dose 2 		Participants will receive eloralintide SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Experimental
Eloralintide Dose 3 		Participants will receive eloralintide SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Experimental
Eloralintide Dose 4 		Participants will receive eloralintide SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Placebo Comparator
Placebo 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

MFA Clinical Research
Tuscaloosa, Alabama 35405
Contact:
205-331-4963

Headlands Research - Scottsdale
Scottsdale, Arizona 85260
Contact:
480-725-8708

Neighborhood Healthcare Institute of Health
Escondido, California 92025
Contact:
760-737-6984

Ark Clinical Research - Fountain Valley
Fountain Valley, California 92708
Contact:
714-988-2021

Desert Oasis Healthcare Medical Group
Palm Springs, California 92262
Contact:
760-320-9505

Peninsula Research Associates
Rolling Hills Estates, California 90274
Contact:
310-265-1623

Southern California Clinical Research
Santa Ana, California 92701
Contact:
714-474-2173

University Clinical Investigators, Inc.
Tustin, California 92780
Contact:
714-734-7944

Chase Medical Research, LLC
Waterbury, Connecticut 06708
Contact:
203-437-6856

JEM Research Institute
Atlantis, Florida 33462
Contact:
561-968-2933

BioMed Research & Medical Center
Miami, Florida 33156
Contact:
786-238-7110

Adult Medicine of Lake County, Inc.
Mt. Dora, Florida 32757
Contact:
352-383-8222

American Research Centers of Florida
Pembroke Pines, Florida 33027
Contact:
954-237-3799

IMA Clinical Research St. Petersburg
St. Petersburg, Florida 33704
Contact:
727-521-9137

Teak Research Consults - Dunwoody
Dunwoody, Georgia 30338

Teak Research Consults
Lawrenceville, Georgia 30043

Clinical Research Atlanta
Stockbridge, Georgia 30281
Contact:
770-507-6867

East-West Medical Research Institute
Honolulu, Hawaii 96814
Contact:
808-531-6886

Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50266
Contact:
515-329-6800

Cotton O'Neil Clinical Research Center
Topeka, Kansas 66606
Contact:
785-354-9591

Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana 70601
Contact:
337-602-6642

MedStar Good Samaritan Hospital
Baltimore, Maryland 21239
Contact:
443-444-6275

MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland 20782
Contact:
443-444-5663

Care Access - Quincy
Quincy, Massachusetts 02169
Contact:
877-791-0656

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098
Contact:
248-312-0025

IMA Clinical Research Warren
Warren Township, New Jersey 07059

Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico 87102
Contact:
505-224-7407

Rochester Clinical Research, LLC
Rochester, New York 14609
Contact:
585-288-0890

Monroe Biomedical Research
Monroe, North Carolina 28112
Contact:
704-283-7359

Preferred Primary Care Physicians
Uniontown, Pennsylvania 15401
Contact:
724-912-0033

Tribe Clinical Research, LLC
Greenville, South Carolina 29607
Contact:
864-334-0141

Accellacare - Mt Pleasant
Mt. Pleasant, South Carolina 29464
Contact:
843-849-1880

AMR Clinical
Nashville, Tennessee 37203
Contact:
630-491-1900

Velocity Clinical Research, Dallas
Dallas, Texas 75230

IMA Clinical Research San Antonio
San Antonio, Texas 78229
Contact:
210-692-7157

AMR Clinical
Norfolk, Virginia 23502
Contact:
757-627-7446

Puerto Rico Health and Wellness Institute
Dorado, Puerto Rico 00646
Contact:
7877961049

Wellness clinical Research Vega Baja
Vega Baja, Puerto Rico 00693
Contact:
787-654-9444

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.