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Purpose

The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.

Conditions

Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower - Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following: - Coronary artery disease - Cerebrovascular disease - Peripheral arterial disease - Chronic kidney disease defined as: - eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m^2) and UACR >30 milligram/gram (mg/g) (0.030 mg/mg) - eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g (0.100 mg/mg), or - eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab) - A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)

Exclusion Criteria

Diabetes related: - Participants have Type 1 Diabetes or any history of diabetic ketoacidosis CV related: - Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization: - Myocardial infarction - Acute coronary syndrome - Stroke, or - Coronary, peripheral, or carotid artery arterial revascularization procedure. - Have acute decompensated heart failure requiring hospitalization. - Have New York Heart Association (NYHA) Classification Class IV heart failure at screening Kidney related: - Participants have an eGFR <20 mL/min/1.73 m^2 at screening - Have UACR >5000 mg/g (5.000 mg/mg) at screening - Have received any form of dialysis ≤ 90 days from the date of randomization - Have either undergone a kidney transplant or have a transplant procedure scheduled Other medical conditions: - Participants have had or plan to have a surgical treatment for obesity, - Have a history of chronic or acute pancreatitis - Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2 - Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction

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
Retatrutide 		Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose.
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
Placebo Comparator
Placebo 		Participants will receive matching placebo administered SC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

Alabama Kidney Research
Alabaster, Alabama 35007

Central Research Associates
Birmingham, Alabama 35205
Contact:
205-327-1077

Alliance for Multispecialty Research, LLC
Daphne, Alabama 36526
Contact:
251-901-2111

Nephrology Consultants
Huntsville, Alabama 35805
Contact:
256-533-4626

Alliance for Multispecialty Research, LLC
Mobile, Alabama 36608
Contact:
251-414-1984

Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Gilbert, Arizona 85296
Contact:
480-691-2213

Sun City Clinical Research
Glendale, Arizona 85304

Arizona Kidney Disease & Hypertension Center (AKDHC) - Thunderbird
Glendale, Arizona 85306
Contact:
602-228-4080

Helios Clinical Research - SAZ-PDV-026
Paradise Valley, Arizona 85253
Contact:
480-535-6589

Banner University Medical Center Phoenix
Phoenix, Arizona 85006

Phoenix Clinical LLC
Phoenix, Arizona 85014

Arizona Cardiovascular Research Center
Phoenix, Arizona 85016
Contact:
602-456-2342

Elite Clinical Studies, LLC
Phoenix, Arizona 85018
Contact:
602-788-3437

Absolute Clinical Research
Phoenix, Arizona 85051

Scottsdale Clinical Trials
Scottsdale, Arizona 85260
Contact:
480-382-7909

Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona 85375
Contact:
623-293-1360

Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona 85741

Cardiology and Medicine Clinic
Little Rock, Arkansas 72204
Contact:
501-664-0941

Kidney & Hypertension Center - Apple Valley
Apple Valley, California 92307
Contact:
760-780-4179

Invivo - Bakersfield
Bakersfield, California 93309

AHF Westside
Beverly Hills, California 90211
Contact:
323-860-5200

American Institute of Research
Beverly Hills, California 90211
Contact:
213-481-7142

Hope Clinical Research, Inc.
Canoga Park, California 91303
Contact:
818-999-4676

Valley Clinical Trials, Inc.
Covina, California 91723
Contact:
626-598-4952

North Coast Cardiology
Encinitas, California 92024
Contact:
760-434-6060

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

HB Clinical Trials - Fountain Valley
Fountain Valley, California 92708
Contact:
657-356-1300

Care Access - Huntington Beach
Huntington Beach, California 92648
Contact:
714-378-2440

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

Scripps Whittier Diabetes Institute
La Jolla, California 92037
Contact:
858-824-5352

Long Beach Research Institute
Long Beach, California 90805

Ark Clinical Research
Long Beach, California 90815
Contact:
562-997-1000

Cedars-Sinai Medical Center
Los Angeles, California 90048

North America Research Institute
Lynwood, California 90262

Valley Clinical Trials, Inc.
Northridge, California 91325
Contact:
818-280-4220

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

California Liver Research Institute
Pasadena, California 91105
Contact:
626-795-5769

Western University of Health Sciences
Pomona, California 91766
Contact:
909-469-8626

California Kidney Specialists
San Dimas, California 91773

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

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

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

Valiance Clinical Research
Tarzana, California 91356
Contact:
818-938-9167

Care Access - Thousand Oaks
Thousand Oaks, California 91360
Contact:
805-778-5143

Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, California 91602

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
Contact:
310-974-9334

UCLA South Bay Endocrinology
Torrance, California 90505

InvivoCure
Van Nuys, California 91405
Contact:
859-509-0084

National Institute of Clinical Research (NICR) - High Desert
Victorville, California 92392
Contact:
760-995-4918

Synexus Clinical Research US, Inc.
Vista, California 92083
Contact:
760-477-7882

Millennium Clinical Trials
Westlake Village, California 91361
Contact:
805-496-3322

Western Nephrology
Arvada, Colorado 80002
Contact:
303-232-3366

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
Contact:
303-724-4651

Cardiology Associates of Fairfield County, P.C.
Stamford, Connecticut 06905
Contact:
203-353-1133

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

Excel Medical Clinical Trials
Boca Raton, Florida 33434
Contact:
561-756-8206

American Research Institute
Cutler Bay, Florida 33157

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

Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida 33312
Contact:
954-963-7100

Florida Kidney Physicians - Fort Lauderdale
Fort Lauderdale, Florida 33316
Contact:
954-463-0112

East Coast Institute for Research, LLC
Jacksonville, Florida 32216
Contact:
904-854-1354

Lakeview Institute of Clinical Research
Leesburg, Florida 34748
Contact:
352-782-0606

Inpatient Research Clinic
Miami Lakes, Florida 33014
Contact:
786-502-4303

Suncoast Research Group
Miami, Florida 33135
Contact:
305-631-6704

New Age Medical Research Corporation
Miami, Florida 33186
Contact:
305-596-9901

Onhealth Research Center
Miami, Florida 33186

Elixia Central Florida
Orlando, Florida 32806
Contact:
407-816-5700 ext 1044

Omega Research Orlando
Orlando, Florida 32808
Contact:
407-988-1075

Florida Kidney Physicians, LLC
Port Charlotte, Florida 33952
Contact:
941-505-8720

Florida Kidney Physicians - Tampa
Riverview, Florida 33578

Cardiovascular Center of Sarasota
Sarasota, Florida 34239
Contact:
941-366-9800

Care Access - Tamarac
Tamarac, Florida 33321
Contact:
855-339-1116

Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa, Florida 33609
Contact:
813-948-7550

Care Access - Tampa
Tampa, Florida 33625

American Clinical Trials - Acworth
Acworth, Georgia 30101

Atlanta Diabetes Associates
Atlanta, Georgia 30318

Emory University School of Medicine
Atlanta, Georgia 30322
Contact:
404-727-3655

Fides Clinical Research
Atlanta, Georgia 30342
Contact:
678-883-6897

Southeastern Clinical Research Institute
Augusta, Georgia 30904
Contact:
706-922-3005

American Clinical Trials - Douglasville
Douglasville, Georgia 30134

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

East Coast Institute for Research, LLC
Macon, Georgia 31210
Contact:
478-219-2017

North Georgia Clinical Research
Woodstock, Georgia 30189
Contact:
678-494-5735

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

Clinical Investigation Specialists
Gurnee, Illinois 60031
Contact:
847-599-2492

Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale
Hinsdale, Illinois 60521

Accellacare - DuPage
Lombard, Illinois 60148
Contact:
630-627-4722

Alliance for Multispecialty Research, LLC
Park Ridge, Illinois 60068

Rockford Nephrology Associates
Rockford, Illinois 61107

Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois 62711
Contact:
217-546-2064

Qualmedica Research, LLC
Evansville, Indiana 47715
Contact:
812-205-2475

Nephrology Associates of Northern Illinois and Indiana (NANI) - Fort Wayne
Fort Wayne, Indiana 46804
Contact:
260-341-4415

Indiana University Health Methodist Hospital
Indianapolis, Indiana 46202

Care Access - South Indianapolis
Indianapolis, Indiana 46227

Nephrology Associates of Northern Illinois and Indiana - IKS - Indianapolis South
Indianapolis, Indiana 46227

Reid Physician Associates
Richmond, Indiana 47374
Contact:
765-962-1337

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

The University of Kansas - Clinical Research Center
Fairway, Kansas 66205

Alliance for Multispecialty Research, LLC
Newton, Kansas 67114
Contact:
316-804-7304

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

Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas 66606
Contact:
785-354-9591

Qualmedica Research
Bowling Green, Kentucky 42101
Contact:
270-685-4589

Alliance for Multispecialty Research, LLC
Lexington, Kentucky 40509
Contact:
859-264-8999

L-MARC Research Center
Louisville, Kentucky 40213
Contact:
502-515-5672

Care Access - Lake Charles
Lake Charles, Louisiana 70601
Contact:
337-602-6642

IMA Clinical Research Monroe - Armand
Monroe, Louisiana 71201

Alliance for Multispecialty Research, LLC
New Orleans, Louisiana 70119
Contact:
504-821-8158 Ext 2470

Sinai Hospital Of Baltimore
Baltimore, Maryland 21209
Contact:
410-367-2590

Care Access - Baltimore
Baltimore, Maryland 21213
Contact:
351-222-4915

Ascension Saint Agnes Heart Care
Baltimore, Maryland 21229
Contact:
443-798-2670

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

Jadestone Clinical Research
Beltsville, Maryland 20705
Contact:
301-595-0356

Anderson Medical Research
Fort Washington, Maryland 20744
Contact:
301-542-6741

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

NECCR PrimaCare Research
Fall River, Massachusetts 02721
Contact:
508-672-7450

Care Access - Quincy
Quincy, Massachusetts 02169
Contact:
650-796-1586

Revival Research Institute, LLC
Dearborn, Michigan 48126

Elixia MKC, LLC
Pontiac, Michigan 48341
Contact:
248-253-0330

Lake Michigan Nephrology
Saint Joseph, Michigan 49085

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

Alliance for Multispecialty Research, LLC
Kansas City, Missouri 64114

StudyMetrix Research
Saint Peters, Missouri 63303
Contact:
636-387-5100

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

Mercy Research - Smith Glynn Callaway
Springfield, Missouri 65807
Contact:
417-888-5660

Mercury Street Medical Group, PLLC
Butte, Montana 59701
Contact:
406-723-1375

Boeson Research MSO
Missoula, Montana 59804
Contact:
406-763-8833

Henderson Clinical Trials
Henderson, Nevada 89052

DaVita Clinical Research - Las Vegas
Las Vegas, Nevada 89107
Contact:
702-877-1887

Excel Clinical Research, LLC
Las Vegas, Nevada 89109
Contact:
702-680-1500

Alliance for Multispecialty Research, LLC
Las Vegas, Nevada 89119
Contact:
702-597-9825

Advanced Biomedical Research of America - South Eastern Avenue
Las Vegas, Nevada 89123
Contact:
702-898-2088

Vector Clinical Trials
Las Vegas, Nevada 89128
Contact:
702-750-0000

Albany Medical College, Division of Community Endocrinology
Albany, New York 12203
Contact:
518-264-4420

Capital Cardiology Associates
Albany, New York 12211

Long Island Cardiovascular Consultants
Lake Success, New York 11042
Contact:
516-627-2121

NYU Langone Health
New York, New York 10016
Contact:
212-263-3166

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
212-241-9101

Northwell Health Physician Peconic
Riverhead, New York 11901
Contact:
631-702-8937

Saratoga Clinical Research
Saratoga Springs, New York 12866
Contact:
518-693-0186

Staten Island University Hospital
Staten Island, New York 10305

Stony Brook University
Stony Brook, New York 11794
Contact:
631-444-1062

Care Access - Fayetteville
Fayetteville, North Carolina 28314
Contact:
910-864-4357

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

Physician's East Endocrinology
Greenville, North Carolina 27834
Contact:
252-413-6683

IMA Clinical Research - Lenoir
Lenoir, North Carolina 28645
Contact:
828-572-5080

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

Accellacare - Raleigh
Raleigh, North Carolina 27609
Contact:
919-783-4895

Accellacare - Wilmington - 1917 Tradd Court
Wilmington, North Carolina 28401
Contact:
910-815-6108

Advanced Medical Research
Maumee, Ohio 43537
Contact:
419-866-6300

Alliance for Multispecialty Research, LLC
Norman, Oklahoma 73069
Contact:
405-701-8999

Good Samaritan Regional Medical Center
Corvallis, Oregon 97330

Heritage Valley Multispecialty Group, Inc
Beaver, Pennsylvania 15009
Contact:
724-770-0935

Northeast Clinical Research Center
Bethlehem, Pennsylvania 18017
Contact:
610-433-4100

Capital Area Research, LLC
Camp Hill, Pennsylvania 17011
Contact:
717-441-1725

Geisinger Medical Center
Danville, Pennsylvania 17822

Lancaster General Hospital
Lancaster, Pennsylvania 17602

Clinical Research of Philadelphia
Philadelphia, Pennsylvania 19114
Contact:
215-676-6696

Tristar Clinical Investigations
Philadelphia, Pennsylvania 19114
Contact:
215-831-0445

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

Guthrie Medical Group, P.C.
Sayre, Pennsylvania 18840

Clinical Renal Associates - Panoramic Science
Upland, Pennsylvania 19013
Contact:
610-872-8501

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
843-792-5873

Accellacare Trident Cardiology
Charleston, South Carolina 29456
Contact:
925-457-8261

Walker Family Care
Little River, South Carolina 29566
Contact:
843-280-8333

Care Access - Mauldin
Mauldin, South Carolina 29662

Circle Clinical Research
Sioux Falls, South Dakota 57104
Contact:
605-215-1159

Alliance for Multispecialty Research, LLC
Knoxville, Tennessee 37920
Contact:
865-305-9100 x246

Care Access - Memphis
Memphis, Tennessee 38128
Contact:
901-230-2232

IMA Clinical Research Austin
Austin, Texas 78745
Contact:
512-649-0082

Headlands Research - Brownsville
Brownsville, Texas 78526

South Texas Clinical Research
Corpus Christi, Texas 78404
Contact:
361-288-4668

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

Baylor Soltero CV Research Center
Dallas, Texas 75226
Contact:
214-820-2273

Velocity Clinical Research, Dallas
Dallas, Texas 75230

North Texas Endocrine Center
Dallas, Texas 75231
Contact:
469-364-6918

Renal Disease Research Institute
Dallas, Texas 75246
Contact:
214-366-6125

UT Southwestern Medical Center
Dallas, Texas 75390-9302
Contact:
870-866-1669

Soma Clinical Trials
Denison, Texas 75020
Contact:
469-819-0228

South Texas Research Institute
Edinburg, Texas 78539

Medresearch Inc
El Paso, Texas 79902-4646
Contact:
915-307-4669

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

Valley Institute of Research - Fort Worth
Fort Worth, Texas 76164
Contact:
817-625-7733

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

Biopharma Informatic, LLC
Houston, Texas 77043
Contact:
281-944-3610

Aqua Research Institute
Houston, Texas 77058
Contact:
281-939-6516

Northwest Houston Cardiology - Cypress
Houston, Texas 77070
Contact:
949-491-0710

Clinical Trial Network
Houston, Texas 77074
Contact:
713-484-6947

PlanIt Research, PLLC
Houston, Texas 77079
Contact:
713-973-3415

Biopharma Informatic, LLC
Houston, Texas 77084
Contact:
281-944-3610

Research Physicians Network, LLC
Houston, Texas 77089
Contact:
281-944-3610

Accurate Clinical Research, Inc
Humble, Texas 77346
Contact:
281-760-3930

Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas 75904
Contact:
936-632-4282

Wellness Clinical Research
McKinney, Texas 75069
Contact:
972-900-3538

PRX Research
Mesquite, Texas 75149

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

National Institute of Clinical Research (NICR) - San Antonio - South Laredo Street
San Antonio, Texas 78204

Clinical Advancement Center
San Antonio, Texas 78212
Contact:
210-223-4444

Discovery Clinical Trials - San Antonio
San Antonio, Texas 78229
Contact:
210-591-1163

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

Endeavor Clinical Trials
San Antonio, Texas 78240
Contact:
518-428-6859

DaVita Clinical Research - North Houston
Shenandoah, Texas 77384
Contact:
346-334-7390

Revival Research Institute, LLC
Sherman, Texas 75092

Medrasa Clinical Research
Wylie, Texas 75098
Contact:
469-449-3645

Alpine Research Organization
Clinton, Utah 84015
Contact:
801-791-2206

Alliance for Multispecialty Research, LLC
Layton, Utah 84041
Contact:
801-679-4153

Synexus Clinical Research US, Inc.
Salt Lake City, Utah 84106
Contact:
801-261-8930

Utah Kidney Research Institute
Salt Lake City, Utah 84115
Contact:
801-747-9186

Alliance for Multispecialty Research, LLC
Norfolk, Virginia 23502
Contact:
757-627-7446

Dominion Medical Associates, Inc.
Richmond, Virginia 23219
Contact:
804-249-2111

Eastside Research Associates
Redmond, Washington 98052
Contact:
425-869-6828

Universal Research Group
Tacoma, Washington 98405
Contact:
253-882-1070

IMA Clinical Research West Virginia
Morgantown, West Virginia 26505
Contact:
304-408-3281

St. Vincent Hospital d/b/a Prevea Health
Green Bay, Wisconsin 54303
Contact:
920-272-3336

Clinical Investigation Specialists
Kenosha, Wisconsin 53144
Contact:
262-925-1280

Advanced Clinical Research, LLC
Bayamón, Puerto Rico 00959
Contact:
7872696590

GCM Medical Group, PSC - Hato Rey Site
San Juan, Puerto Rico 00917
Contact:
7879362100

More Details

NCT ID
NCT06383390
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@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.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

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