A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
TRIUMPH-3
A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease
3 other identifiers
interventional
1,800
10 countries
169
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started May 2023
Typical duration for phase_3 obesity
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2023
CompletedStudy Start
First participant enrolled
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
May 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJuly 23, 2025
July 1, 2025
2.8 years
May 22, 2023
July 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight
Baseline, Week 80
Secondary Outcomes (10)
Change from Baseline in Body Mass Index (BMI)
Baseline, Week 80
Change from Baseline in Waist Circumference
Baseline, Week 80
Percent Change from Baseline in Total Cholesterol
Baseline, Week 80
Percent Change from Baseline in Triglycerides
Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Baseline, Week 80
- +5 more secondary outcomes
Study Arms (3)
Retatrutide Dose 1
EXPERIMENTALParticipants will receive retatrutide subcutaneously (SC).
Retatrutide Dose 2
EXPERIMENTALParticipants will receive retatrutide SC.
Placebo
PLACEBO COMPARATORParticipants will receive placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
- Have established cardiovascular (CV) disease with at least 1 of the following:
- prior myocardial infarction
- prior ischemic or hemorrhagic stroke, or
- symptomatic peripheral arterial disease
- Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.
You may not qualify if:
- Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- Have a prior or planned surgical treatment of obesity.
- Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
- Have Type 1 diabetes.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had pancreatitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (169)
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Valley Clinical Trials, Inc.
Covina, California, 91723, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Valley Research
Fresno, California, 93720, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720, United States
Velocity Clinical Research, Westlake
Los Angeles, California, 90057, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Velocity Clinical Research, Panorama City
Van Nuys, California, 91405, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Charter Research - Winter Park
Orlando, Florida, 32803, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Humphreys Diabetes Center
Boise, Idaho, 83702, United States
Northwestern University
Chicago, Illinois, 60611, United States
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois, 60031, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, 62711, United States
Brengle Family Medicine
Indianapolis, Indiana, 46260, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128, United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
UPMC Montefiore University Hospital
Pittsburgh, Pennsylvania, 15213, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Trial Management Associates
Myrtle Beach, South Carolina, 29572, United States
Tribe Clinical Research - Spartanburg
Spartanburg, South Carolina, 29301, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731, United States
Pinnacle Clinical Research
Austin, Texas, 78757, United States
South Texas Clinical Research
Corpus Christi, Texas, 78404, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681, United States
Sleep Therapy Research Center
San Antonio, Texas, 78229, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
CEDIC
CABA, Buenos Aires, C1060ABN, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056, Argentina
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, Buenos Aires, C1012AAR, Argentina
MICA - Medicina e Investigación Cardiometabólica
Del Viso, Buenos Aires, 1669, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, 7600, Argentina
DIM Clínica Privada
Ramos Mejía, Buenos Aires, B1704ETD, Argentina
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, Buenos Aires F.D., 1405, Argentina
Stat Research S.A.
Buenos Aires, Buenos Aires F.D., C1023AAB, Argentina
Investigaciones Medicas Imoba Srl
Buenos Aires, Buenos Aires F.D., C1056ABH, Argentina
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Buenos Aires F.D., C1425AGC, Argentina
Centro Medico Privado CEMAIC
Capital, Córdoba Province, X5008HHW, Argentina
Centro Medico Privado San Vicente Diabetes
Córdoba, Córdoba Province, 5006, Argentina
Centro de Salud e Investigaciones Médicas
Santa Rosa, La Pampa Province, 6300, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz, Mendoza Province, 5501, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, Santa Fe Province, 2152, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, 2000, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio San Martin
Venado Tuerto, Santa Fe Province, 2600, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
Instituto Médico DAMIC
Córdoba, 5003DCE, Argentina
Centro de Investigaciones Clinicas del Litoral
Santa Fe, S3000FWO, Argentina
Sanatorio Norte
Santiago del Estero, 4200, Argentina
Canberra Hospital
Canberra, Australian Capital Territory, 2605, Australia
Emeritus Research
Botany, New South Wales, 2019, Australia
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100, Australia
Camden Hospital
Camden, New South Wales, 2570, Australia
The AIM Centre / Hunter Diabetes Centre
Merewether, New South Wales, 2291, Australia
University of Sydney - Charles Perkins Centre
Sydney, New South Wales, 2006, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Core Research Group
Brisbane, Queensland, 4064, Australia
CDH Research Institute
Maroochydore, Queensland, 4558, Australia
Logan Hospital
Meadowbrook, Queensland, 4131, Australia
Fusion Clinical Research
Adelaide, South Australia, 5000, Australia
Nightingale Research
Adelaide, South Australia, 5000, Australia
Southern Adelaide Diabetes & Endocrine Services
Mount Gambier, South Australia, 5290, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, 5046, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
Austin Health - Repatriation Hospital
Heidelberg West, Victoria, 3081, Australia
One Clinical Research
Nedlands, Western Australia, 6009, Australia
BC Diabetes Office
Vancouver, British Columbia, V5Y 3W2, Canada
Discovery Clinical Services
Victoria, British Columbia, V8T 5G4, Canada
Joanne F. Liutkus Medicine Professional Corporation
Cambridge, Ontario, N3H 4L5, Canada
LMC Clinical Research Inc. (Thornhill)
Concord, Ontario, L4K 4M2, Canada
Dr. Steven V. Zizzo Research Professional Corporation
Hamilton, Ontario, L8J 0B6, Canada
Milestone Research Inc.
London, Ontario, N5W 6A2, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7, Canada
Centricity Research Oshawa
Oshawa, Ontario, L1J 2K9, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2, Canada
Manna Research Toronto
Toronto, Ontario, M9W 4L6, Canada
Ecogene-21 - Cmas
Chicoutimi, Quebec, G7H 0S7, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Clinique de médecine Urbaine du Quartier Latin
Montreal, Quebec, H2L 4E9, Canada
CardioVasc HR Inc
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2, Canada
Centre de Medecine Metabolique de Lanaudiere (CMML)
Terrebonne, Quebec, J6X 4P7, Canada
C.I.C. Mauricie inc.
Trois-Rivières, Quebec, G8T 7A1, Canada
Syneos Health
Québec, G1P0A2, Canada
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, 6725, Hungary
Regia Med Kft
Székesfehérvár, Fejér, 8000, Hungary
Medifarma 98 Kft
Nyíregyháza, Nyíregyháza, 4400, Hungary
Szent Lázár Megyei Kórház
Salgótarján, Nógrád megye, 3100, Hungary
Óbudai Egészségügyi Centrum - Kaposvár Site
Kaposvár, Somogy County, 7400, Hungary
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém megye, 8230, Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, Zala County, 8900, Hungary
Óbudai Egészségügyi Centrum
Budapest, 1036, Hungary
ClinDiab Kft.
Budapest, 1089, Hungary
TRANTOR'99 Bt. Anyagcsere Centrum
Budapest, 1213, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, 4031, Hungary
Óbudai Egészségügyi Centrum - Zalaegerszeg
Zalaegerszeg, 8900, Hungary
Centro de Investigacion Cardiovascular y Metabólica
Tijuana, Estado de Baja California, 22500, Mexico
Centro Multidisciplinario de Diabetes de Pachuca
Pachuca, Hidalgo, 42084, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA
Guadalajara, Jalisco, 44670, Mexico
Centro de Investigacion Medica de Occidente, S.C.
Zapopan, Jalisco, 44260, Mexico
RM Pharma Specialists
Mexico City, Mexico City, 03100, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, 11650, Mexico
IMED Internal Medicine Clin Trials
Monterrey, Nuevo León, 64060, Mexico
Clínica García Flores SC
Monterrey, Nuevo León, 64610, Mexico
Eukarya PharmaSite
Monterrey, Nuevo León, 64718, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460, Mexico
EME RED Hospitalaria
Mérida, Yucatán, 97000, Mexico
Medical Care and Research SA de CV
Mérida, Yucatán, 97070, Mexico
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
Chihuahua City, 31110, Mexico
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
Durango, 34000, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí
San Luis Potosí City, 78200, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900, Mexico
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261, Poland
NBR Polska
Warsaw, Masovian Voivodeship, 00-710, Poland
KLIMED Marek Klimkiewicz
Bialystok, Podlaskie Voivodeship, 15-704, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship, 40-081, Poland
NZOZ Salvia CM
Katowice, Silesian Voivodeship, 40-772, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Zabrze, Silesian Voivodeship, 41-800, Poland
Ambulatorium Sp. z o.o.
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódź Voivodeship, 90338, Poland
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
Clinical Research Management Group Inc
Ponce, 00717, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
Nemocnica s poliklinikou Lucenec
Lučenec, Banská Bystrica Region, 984 01, Slovakia
Metabol KLINIK
Bratislava, Bratislava Region, 811 08, Slovakia
MediVet s.r.o.
Malacky, Bratislava Region, 901 01, Slovakia
Human Care s.r.o.
Košice, Košice Region, 04001, Slovakia
Tatratrial s.r.o.
Rožňava, Košice Region, 04801, Slovakia
Areteus s.r.o.
Trebišov, Košice Region, 075 01, Slovakia
MEDI-DIA s.r.o.
Sabinov, Presov, 083 01, Slovakia
MediTask
Bratislava, 831 03, Slovakia
Diab - Int
Bytča, Žilina Region, 014 01, Slovakia
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, A Coruña [La Coruña], 15405, Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Hospital Quiron Infanta Luisa
Seville, Andalusia, 41010, Spain
Hospital Universitari Son Espases
Palma, Balears [Baleares], 07120, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Virgen del Camino
Sanlúcar de Barrameda, Cádiz, 11540, Spain
Hospital Virgen de las Montañas
Villamartín, Cádiz, 11650, Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Lleida [Lérida], 25198, Spain
Vithas Hospital Sevilla
Seville, Sevilla, 41950, Spain
Hospital Universitario de La Ribera
Alzira, Valenciana, Comunitat, 46600, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28009, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2023
First Posted
May 31, 2023
Study Start
May 30, 2023
Primary Completion
April 1, 2026
Study Completion
May 1, 2026
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.