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Purpose

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.

Conditions

Eligibility

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

Inclusion Criteria

  • Have type 2 diabetes - Are on stable treatment for type 2 diabetes for at least 90 days prior to screening - Have a BMI ≥ 27 kg/m2 - Have a stable body weight (<5% body weight change) for 90 days prior to 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: - amylin analogs - glucagon-like peptide-1 (GLP-1) receptor agonists - glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or - 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 - 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

Birmingham Clinical Research
Birmingham, Alabama 35209
Contact:
205-870-4343

Cullman Clinical Trials
Cullman, Alabama 35055
Contact:
256-708-2826

Tucson Clinical Research Institute
Tucson, Arizona 85712

San Fernando Valley Health Institute
Canoga Park, California 91304
Contact:
818-222-6868

AMCR Institute
Escondido, California 92025
Contact:
760-466-1520

NorCal Medical Research, Inc
Greenbrae, California 94904
Contact:
415-461-1585

Inglewood Clinical
Inglewood, California 90301
Contact:
310-693-5000

Ark Clinical Research
Long Beach, California 90815

Pacific Clinical Studies
Los Alamitos, California 90720
Contact:
562-598-0600 ext 205

Care Access - Santa Clarita
Santa Clarita, California 91321
Contact:
661-371-7272

Encompass Clinical Research
Spring Valley, California 91978
Contact:
619-660-9068

Diablo Clinical Research, Inc.
Walnut Creek, California 94598
Contact:
925-930-7267

Care Access - Aurora
Aurora, Colorado 80012
Contact:
720-368-4865

New England Research Associates, LLC
Bridgeport, Connecticut 06606
Contact:
203-374-9816

CMR of Greater New Haven, LLC
Hamden, Connecticut 06517

Arrow Clinical Trials
Daytona Beach, Florida 32117
Contact:
386-278-8000

Care Access - Delray Beach
Delray Beach, Florida 33484
Contact:
401-773-7855

Fleming Island Center for Clinical Research
Fleming Island, Florida 32003
Contact:
904-621-0390

Nature Coast Clinical Research - Inverness
Inverness, Florida 34452
Contact:
352-341-2100

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

Flourish Research Acquisition, LLC dba Flourish Research - North Miami
Miami, Florida 33138
Contact:
786-772-0411

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

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

Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida 32789
Contact:
407-740-8078

Teak Research Consults - Dunwoody
Dunwoody, Georgia 30338

Teak Research Consults
Lawrenceville, Georgia 30043

The Jones Center Clinical Research
Macon, Georgia 31210

Pacific Diabetes & Endocrine Center
Honolulu, Hawaii 96817
Contact:
808-526-0303

NorthShore University Health System
Skokie, Illinois 60077
Contact:
847-663-8540

DM Clinical Research - Indianapolis
Indianapolis, Indiana 46254
Contact:
463-271-3050

Clinical Trials Management, LLC d/b/a Flourish Research
Metairie, Louisiana 70006
Contact:
504-455-1310

IMA Clinical Research Monroe - Armand
Monroe, Louisiana 71201

Centennial Medical Group
Columbia, Maryland 21045
Contact:
410-730-3399

Lucida Clinical Trials
New Bedford, Massachusetts 02740
Contact:
508-720-2015

Clinical Research Professionals
Chesterfield, Missouri 63005
Contact:
636-220-1200

Clinvest Headlands Llc
Springfield, Missouri 65807
Contact:
417-883-7889

Hypertension & Nephrology Association
Eatontown, New Jersey 07724

IMA Clinical Research Warren
Warren Township, New Jersey 07059

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

NYC Research INC
Long Island City, New York 11106
Contact:
516-574-9232

PharmQuest Life Sciences, LLC
Greensboro, North Carolina 27408
Contact:
336-574-8020

West Clinical Research
Morehead City, North Carolina 28557
Contact:
252-515-0050

Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina 28403

Lillestol Research
Fargo, North Dakota 58104
Contact:
701-232-7705

Care Access - Lima
Lima, Ohio 45805

Summit Headlands
Portland, Oregon 97210

Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania 15243
Contact:
412-942-0023

Preferred Primary Care Physicians
Uniontown, Pennsylvania 15401
Contact:
724-438-1479

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

IMA Clinical Research Austin
Austin, Texas 78745

Private Practice - Dr. Osvaldo A. Brusco
Corpus Christi, Texas 78414
Contact:
361-885-0448

Velocity Clinical Research, Dallas
Dallas, Texas 75230

Diabetes and Thyroid Center of Ft. Worth
Fort Worth, Texas 76132
Contact:
817-263-0007

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

Southern Endocrinology Associates
Mesquite, Texas 75149
Contact:
214-693-0904

Research Your Health
Plano, Texas 75093
Contact:
9729991155 x103

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

Ogden Clinic - Canyon View
Ogden, Utah 84404
Contact:
385-271-0684

Diabetes & Endocrine Treatment Specialists
Sandy City, Utah 84093
Contact:
801-816-1010

Centro de Endocrinologia y Nutricion
Caguas, Puerto Rico 00725
Contact:
7877467057

Dorado Medical Complex
Dorado, Puerto Rico 00646
Contact:
787278-1576

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

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.