A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin

Purpose

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.

Conditions

  • Overweight
  • Obesity

Eligibility

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

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

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

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

Novak Clinical Research - Tucson - North La Cholla Boulevard
Tucson, Arizona 85741

Irvine Clinical Research
Irvine, California 92614
Contact:
949-753-1663

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

Care Access - Sacramento
Sacramento, California 95831
Contact:
925-734-2331

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

Chase Medical Research, LLC
Waterbury, Connecticut 06708
Contact:
203-419-4420

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

AMR Clinical
Doral, Florida 33172

Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
Contact:
904-730-0101

New Horizon Research Center
Miami, Florida 33165
Contact:
305-226-3933

St Johns Center for Clinical Research
Saint Augustine, Florida 32086
Contact:
904-209-0043

Metabolic Research Institute, Inc.
West Palm Beach, Florida 33401
Contact:
561-802-3060

Teak Research Consults - Dunwoody
Dunwoody, Georgia 30338
Contact:
470-403-4755

Center for Advanced Research & Education
Gainesville, Georgia 30501
Contact:
770-534-5154

Family First Medical Center
Idaho Falls, Idaho 83404
Contact:
208-552-7700

Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640
Contact:
773-275-3500 Ext 126

AMR Clinical
Lexington, Kentucky 40509
Contact:
859-264-8999

Great Lakes Research Institute
Southfield, Michigan 48075
Contact:
248-864-5242

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

Medication Management
Greensboro, North Carolina 27405
Contact:
336-763-6968

Accellacare - Wilmington - 1917 Tradd Court
Wilmington, North Carolina 28401
Contact:
910-799-5500

Care Access - Lima
Lima, Ohio 45805

Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania 15236
Contact:
412-650-6155

Juno Research
Houston, Texas 77040
Contact:
713-779-5494

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

Consano Clinical Research, LLC
Shavano Park, Texas 78231
Contact:
210-545-4900

Texas Valley Clinical Research
Weslaco, Texas 78596
Contact:
956-431-8090

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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