A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

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

  • Obesity
  • Overweight

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