RECRUITING

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

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Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)Chronic Kidney Disease (CKD)Cardiovascular DiseaseKidney DiseaseMajor Adverse Cardiovascular Events (MACE)Renal OutcomesCardiovascular Risk ReductionKidney Disease ProgressionCardiometabolic Risk FactorsCardiovascular OutcomesKidney OutcomesType 2 DiabetesHeart DiseaseCoronary Artery DiseaseCerebrovascular DiseasePeripheral Arterial DiseaseNonfatal Myocardial Infarction (MI)Nonfatal StrokeCardiovascular (CV) DeathHospitalization or Urgent Visit Due to Heart Failure (HF)Renal DeathEnd Stage Kidney Disease (ESKD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Quick Facts

Study Start:2024-04-30
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06383390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower
  2. * Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following:
  3. * Coronary artery disease
  4. * Cerebrovascular disease
  5. * Peripheral arterial disease
  6. * Chronic kidney disease defined as:
  7. * eGFR \<45 millilitres/minute/1.73 meter squared (mL/min/1.73m\^2) and UACR \>30 milligram/gram (mg/g) (0.030 mg/mg)
  8. * eGFR \<60 mL/min/1.73 m\^2 and UACR \>100 mg/g (0.100 mg/mg), or
  9. * 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)
  10. * A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m\^2)
  1. * Participants have Type 1 Diabetes or any history of diabetic ketoacidosis
  2. * Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization:
  3. * Myocardial infarction
  4. * Acute coronary syndrome
  5. * Stroke, or
  6. * Coronary, peripheral, or carotid artery arterial revascularization procedure.
  7. * Have acute decompensated heart failure requiring hospitalization.
  8. * Have New York Heart Association (NYHA) Classification Class IV heart failure at screening
  9. * Participants have an eGFR \<20 mL/min/1.73 m\^2 at screening
  10. * Have UACR \>5000 mg/g (5.000 mg/mg) at screening
  11. * Have received any form of dialysis ≤ 90 days from the date of randomization
  12. * Have either undergone a kidney transplant or have a transplant procedure scheduled
  13. * Participants have had or plan to have a surgical treatment for obesity,
  14. * Have a history of chronic or acute pancreatitis
  15. * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2
  16. * Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
ClinicalTrials.gov@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Central Research Associates
Birmingham, Alabama, 35205
United States
Alliance for Multispecialty Research, LLC
Daphne, Alabama, 36526
United States
Nephrology Consultants
Huntsville, Alabama, 35805
United States
Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608
United States
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Gilbert, Arizona, 85296
United States
Helios Clinical Research - SAZ-PDV-026
Paradise Valley, Arizona, 85253
United States
AMZERN Clinical Trial Organization
Peoria, Arizona, 85381
United States
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
United States
Phoenix Clinical LLC
Phoenix, Arizona, 85014
United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018
United States
Absolute Clinical Research
Phoenix, Arizona, 85051
United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, 85375
United States
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, 85741
United States
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204
United States
Kidney & Hypertension Center - Apple Valley
Apple Valley, California, 92307
United States
Invivo - Bakersfield
Bakersfield, California, 93309
United States
AHF Westside
Beverly Hills, California, 90211
United States
American Institute of Research
Beverly Hills, California, 90211
United States
Hope Clinical Research, Inc.
Canoga Park, California, 91303
United States
Valley Clinical Trials, Inc.
Covina, California, 91723
United States
North Coast Cardiology
Encinitas, California, 92024
United States
Neighborhood Healthcare Institute of Health
Escondido, California, 92025
United States
HB Clinical Trials - Fountain Valley
Fountain Valley, California, 92708
United States
Care Access - Huntington Beach
Huntington Beach, California, 92648
United States
Irvine Clinical Research
Irvine, California, 92614
United States
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
United States
Long Beach Research Institute
Long Beach, California, 90805
United States
Ark Clinical Research
Long Beach, California, 90815
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
North America Research Institute
Lynwood, California, 90262
United States
Valley Clinical Trials, Inc.
Northridge, California, 91325
United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
United States
California Liver Research Institute
Pasadena, California, 91105
United States
Western University of Health Sciences
Pomona, California, 91766
United States
California Kidney Specialists
San Dimas, California, 91773
United States
Southern California Clinical Research
Santa Ana, California, 92701
United States
Care Access - Santa Clarita
Santa Clarita, California, 91321
United States
Encompass Clinical Research
Spring Valley, California, 91978
United States
Valiance Clinical Research
Tarzana, California, 91356
United States
Care Access - Thousand Oaks
Thousand Oaks, California, 91360
United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, California, 91602
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
United States
UCLA South Bay Endocrinology
Torrance, California, 90505
United States
InvivoCure
Van Nuys, California, 91405
United States
National Institute of Clinical Research (NICR) - High Desert
Victorville, California, 92392
United States
Synexus Clinical Research US, Inc.
Vista, California, 92083
United States
Millennium Clinical Trials
Westlake Village, California, 91361
United States
Western Nephrology
Arvada, Colorado, 80002
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Cardiology Associates of Fairfield County, P.C.
Stamford, Connecticut, 06905
United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003
United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
United States
Florida Kidney Physicians - Fort Lauderdale
Fort Lauderdale, Florida, 33316
United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216
United States
Inpatient Research Clinic
Miami Lakes, Florida, 33014
United States
Suncoast Research Group
Miami, Florida, 33135
United States
New Age Medical Research Corporation
Miami, Florida, 33186
United States
Elixia Central Florida
Orlando, Florida, 32806
United States
Omega Research Orlando
Orlando, Florida, 32808
United States
Florida Kidney Physicians, LLC
Port Charlotte, Florida, 33952
United States
Florida Kidney Physicians - Tampa
Riverview, Florida, 33578
United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
United States
Care Access - Tamarac
Tamarac, Florida, 33321
United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa, Florida, 33609
United States
Care Access - Tampa
Tampa, Florida, 33625
United States
American Clinical Trials - Acworth
Acworth, Georgia, 30101
United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
United States
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Fides Clinical Research
Atlanta, Georgia, 30342
United States
Southeastern Clinical Research Institute
Augusta, Georgia, 30904
United States
American Clinical Trials - Douglasville
Douglasville, Georgia, 30134
United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501
United States
East Coast Institute for Research, LLC
Macon, Georgia, 31210
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
United States
Clinical Investigation Specialists
Gurnee, Illinois, 60031
United States
Accellacare - DuPage
Lombard, Illinois, 60148
United States
Alliance for Multispecialty Research, LLC
Park Ridge, Illinois, 60068
United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, 62711
United States
Qualmedica Research, LLC
Evansville, Indiana, 47715
United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
United States
Care Access - South Indianapolis
Indianapolis, Indiana, 46227
United States
Reid Physician Associates
Richmond, Indiana, 47374
United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
United States
The University of Kansas - Clinical Research Center
Fairway, Kansas, 66205
United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114
United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
United States
Qualmedica Research
Bowling Green, Kentucky, 42101
United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509
United States
L-MARC Research Center
Louisville, Kentucky, 40213
United States
Christus Health Research Center
Alexandria, Louisiana, 71301
United States
Care Access - Lake Charles
Lake Charles, Louisiana, 70601
United States
IMA Clinical Research Monroe - Armand
Monroe, Louisiana, 71201
United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, 70119
United States
Care Access - Baltimore
Baltimore, Maryland, 21213
United States
Sinai Hospital Of Baltimore
Baltimore, Maryland, 21215
United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239
United States
Jadestone Clinical Research
Beltsville, Maryland, 20705
United States
Anderson Medical Research
Fort Washington, Maryland, 20744
United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, 20782
United States
Care Access - Dorchester
Dorchester, Massachusetts, 02124
United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721
United States
Revival Research Institute, LLC
Dearborn, Michigan, 48126
United States
Elixia MKC, LLC
Pontiac, Michigan, 48341
United States
Lake Michigan Nephrology
Saint Joseph, Michigan, 49085
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114
United States
StudyMetrix Research
Saint Peters, Missouri, 63303
United States
Clinvest Headlands Llc
Springfield, Missouri, 65807
United States
Mercy Research - Smith Glynn Callaway
Springfield, Missouri, 65807
United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
United States
Boeson Research MSO
Missoula, Montana, 59804
United States
Henderson Clinical Trials
Henderson, Nevada, 89052
United States
DaVita Clinical Research - Las Vegas
Las Vegas, Nevada, 89107
United States
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109
United States
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, 89119
United States
Advanced Biomedical Research of America - South Eastern Avenue
Las Vegas, Nevada, 89123
United States
Vector Clinical Trials
Las Vegas, Nevada, 89128
United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203
United States
Capital Cardiology Associates
Albany, New York, 12211
United States
Westchester Medical Center Advanced Physicians Service
Kingston, New York, 12401
United States
Long Island Cardiovascular Consultants
Lake Success, New York, 11042
United States
NYU Langone Health
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Northwell Health Physician Peconic
Riverhead, New York, 11901
United States
Saratoga Clinical Research
Saratoga Springs, New York, 12866
United States
Staten Island University Hospital
Staten Island, New York, 10305
United States
Stony Brook University
Stony Brook, New York, 11794
United States
Care Access - Fayetteville
Fayetteville, North Carolina, 28314
United States
Medication Management
Greensboro, North Carolina, 27405
United States
Physician's East Endocrinology
Greenville, North Carolina, 27834
United States
IMA Clinical Research - Lenoir
Lenoir, North Carolina, 28645
United States
West Clinical Research
Morehead City, North Carolina, 28557
United States
Accellacare - Raleigh
Raleigh, North Carolina, 27609
United States
Accellacare - Wilmington - 1917 Tradd Court
Wilmington, North Carolina, 28401
United States
Advanced Medical Research
Maumee, Ohio, 43537
United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
United States
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
United States
Heritage Valley Multispecialty Group, Inc
Beaver, Pennsylvania, 15009
United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
United States
Tristar Clinical Investigations
Philadelphia, Pennsylvania, 19114
United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, 15243
United States
Guthrie Medical Group, P.C.
Sayre, Pennsylvania, 18840
United States
Clinical Renal Associates - Panoramic Science
Upland, Pennsylvania, 19013
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Accellacare Trident Cardiology
Charleston, South Carolina, 29456
United States
Walker Family Care
Little River, South Carolina, 29566
United States
Care Access - Mauldin
Mauldin, South Carolina, 29662
United States
Circle Clinical Research
Sioux Falls, South Dakota, 57104
United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
United States
Care Access - Memphis
Memphis, Tennessee, 38128
United States
IMA Clinical Research Austin
Austin, Texas, 78745
United States
Headlands Research - Brownsville
Brownsville, Texas, 78526
United States
South Texas Clinical Research
Corpus Christi, Texas, 78404
United States
Private Practice - Dr. Osvaldo A. Brusco
Corpus Christi, Texas, 78414
United States
Baylor Soltero CV Research Center
Dallas, Texas, 75226
United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
United States
North Texas Endocrine Center
Dallas, Texas, 75231
United States
Renal Disease Research Institute
Dallas, Texas, 75246
United States
UT Southwestern Medical Center
Dallas, Texas, 75390-9302
United States
Soma Clinical Trials
Denison, Texas, 75020
United States
South Texas Research Institute
Edinburg, Texas, 78539
United States
Medresearch Inc
El Paso, Texas, 79902-4646
United States
Diabetes and Thyroid Center of Ft. Worth
Fort Worth, Texas, 76132
United States
Valley Institute of Research - Fort Worth
Fort Worth, Texas, 76164
United States
Juno Research
Houston, Texas, 77040
United States
Biopharma Informatic, LLC
Houston, Texas, 77043
United States
Aqua Research Institute
Houston, Texas, 77058
United States
Northwest Houston Cardiology - Cypress
Houston, Texas, 77070
United States
Clinical Trial Network
Houston, Texas, 77074
United States
PlanIt Research, PLLC
Houston, Texas, 77079
United States
Biopharma Informatic, LLC
Houston, Texas, 77084
United States
Research Physicians Network, LLC
Houston, Texas, 77089
United States
Accurate Clinical Research, Inc
Humble, Texas, 77346
United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, 75904
United States
Wellness Clinical Research
McKinney, Texas, 75069
United States
PRX Research
Mesquite, Texas, 75149
United States
Southern Endocrinology Associates
Mesquite, Texas, 75149
United States
National Institute of Clinical Research (NICR) - San Antonio - South Laredo Street
San Antonio, Texas, 78204
United States
Clinical Advancement Center
San Antonio, Texas, 78212
United States
Discovery Clinical Trials - San Antonio
San Antonio, Texas, 78229
United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
United States
Endeavor Clinical Trials
San Antonio, Texas, 78240
United States
DaVita Clinical Research - North Houston
Shenandoah, Texas, 77384
United States
Revival Research Institute, LLC
Sherman, Texas, 75092
United States
Medrasa Clinical Research
Wylie, Texas, 75098
United States
Alpine Research Organization
Clinton, Utah, 84015
United States
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041
United States
Synexus Clinical Research US, Inc.
Salt Lake City, Utah, 84106
United States
Utah Kidney Research Institute
Salt Lake City, Utah, 84115
United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, 23502
United States
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219
United States
Eastside Research Associates
Redmond, Washington, 98052
United States
Universal Research Group
Tacoma, Washington, 98405
United States
IMA Clinical Research West Virginia
Morgantown, West Virginia, 26505
United States
St. Vincent Hospital d/b/a Prevea Health
Green Bay, Wisconsin, 54303
United States
Clinical Investigation Specialists
Kenosha, Wisconsin, 53144
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-30
Study Completion Date2029-02

Study Record Updates

Study Start Date2024-04-30
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

  • Cardiovascular Disease
  • Kidney Disease
  • Major Adverse Cardiovascular Events (MACE)
  • Renal Outcomes
  • Cardiovascular Risk Reduction
  • Kidney Disease Progression
  • Cardiometabolic Risk Factors
  • Cardiovascular Outcomes
  • Kidney Outcomes
  • Type 2 Diabetes
  • Heart Disease
  • Coronary Artery Disease
  • Cerebrovascular Disease
  • Peripheral Arterial Disease
  • Nonfatal Myocardial Infarction (MI)
  • Nonfatal Stroke
  • Cardiovascular (CV) Death
  • Hospitalization or Urgent Visit Due to Heart Failure (HF)
  • Renal Death
  • End Stage Kidney Disease (ESKD)

Additional Relevant MeSH Terms

  • Atherosclerotic Cardiovascular Disease (ASCVD)
  • Chronic Kidney Disease (CKD)