A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Obesity Clinical Trial

— TRIUMPH-3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882045
• Other study ID #: 18582
• Secondary ID: J1I-MC-GZBM2023-
• Status: Recruiting
• Phase: Phase 3
• Start date: May 30, 2023
• Est. completion date: February 17, 2026

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial -877-CTLILLY
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: February 17, 2026
• Est. primary completion date: January 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity

Intervention

Drug:
• Retatrutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Aut
Argentina	Fundación Respirar	Buenos Aires
Argentina	Investigaciones Medicas Imoba Srl	Buenos Aires	Ciudad Aut
Argentina	Stat Research S.A.	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CEDIC	Caba	Buenos Aires
Argentina	Centro Medico Privado CEMAIC	Capital	Córdoba
Argentina	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire
Argentina	Consultorio de Investigación Clínica EMO SRL	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas	Ciudad de Buenos Aires	Buenos Aires
Argentina	Centro Medico Privado San Vicente Diabetes	Cordoba	Córdoba
Argentina	Instituto Médico DAMIC	Córdoba
Argentina	MICA - Medicina e Investigación Cardiometabólica	Del Viso	Buenos Aires
Argentina	CIPADI - Centro Integral de Prevencion y Atencion en Diabetes	Godoy Cruz	Mendoza
Argentina	Centro de Investigaciones Clínicas Baigorria	Granadero Baigorria	Santa Fe
Argentina	Instituto de Investigaciones Clínicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	DIM Clínica Privada	Ramos Mejía	Buenos Aires
Argentina	INECO Neurociencias Oroño	Rosario	Santa Fe
Argentina	Instituto de Investigaciones Clinicas Rosario	Rosario	Santa Fe
Argentina	Centro Medico Privado de Reumatologia	SAN M. DE Tucuman	Tucumán
Argentina	Centro de Investigaciones Clinicas del Litoral	Santa Fe
Argentina	Centro de Salud e Investigaciones Médicas	Santa Rosa	La Pampa
Argentina	Sanatorio Norte	Santiago del Estero	Santiago D
Argentina	Sanatorio San Martin	Venado Tuerto	Santa Fe
Australia	Fusion Clinical Research	Adelaide	South Australia
Australia	Nightingale Research	Adelaide	South Aust
Australia	Optimus Clinical Research	Botany	New South Wales
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Core Research Group	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Northern Beaches Clinical Research	Brookvale	New South Wales
Australia	Emeritus Research	Camberwell	Victoria
Australia	Canberra Hospital	Canberra	Australian Capital Territory
Australia	Barwon Health	Geelong	Victoria
Australia	Austin Health - Repatriation Hospital	Heidelberg West	Victoria
Australia	Coastal Digestive Health	Maroochydore	Queensland
Australia	Logan Hospital	Meadowbrook	Queensland
Australia	The AIM Centre / Hunter Diabetes Centre	Merewether	New South Wales
Australia	Southern Adelaide Diabetes & Endocrine Services	Mount Gambier	South Australia
Australia	One Clinical Research	Nedlands	Western Australia
Australia	Southern Adelaide Diabetes & Endocrine Services	Oaklands Park	South Australia
Australia	University of Sydney - Charles Perkins Centre	Sydney	New South Wales
Canada	Ecogene-21	Chicoutimi	Quebec
Canada	Ecogene-21 - Cmas	Chicoutimi	Quebec
Canada	LMC Clinical Research Inc. (Thornhill)	Concord	Ontario
Canada	Dr. Steven V. Zizzo Medicine Professional Corporation	Hamilton	Ontario
Canada	Milestone Research Inc.	London	Ontario
Canada	Clinique de médecine Urbaine du Quartier Latin	Montreal	Quebec
Canada	North York Diagnostic and Cardiac Centre	North York	Ontario
Canada	Centricity Research Oshawa	Oshawa	Ontario
Canada	Kawartha Cardiology Clinical Trials	Peterborough	Ontario
Canada	C.I.C. Mauricie inc.	Quebec
Canada	CardioVasc HR Inc	Saint-Jean-sur-Richelieu	Quebec
Canada	Centre de Medecine Metabolique de Lanaudiere (CMML)	Terrebonne	Quebec
Canada	Manna Research Toronto	Toronto	Ontario
Canada	C.I.C. Mauricie inc.	Trois-Rivières	Quebec
Canada	BC Diabetes Office	Vancouver	British Columbia
Canada	Discovery Clinical Services	Victoria	British Columbia
Hungary	DRC Gyógyszervizsgáló Központ	Balatonfüred	Veszprém
Hungary	ClinDiab Kft.	Budapest
Hungary	Óbudai Egészségügyi Centrum	Budapest
Hungary	TRANTOR'99 Bt. Anyagcsere Centrum	Budapest
Hungary	Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház	Debrecen
Hungary	Óbudai Egészségügyi Centrum - Kaposvár Site	Kaposvár	Somogy
Hungary	Medifarma 98 Kft	Nyiregyhaza	Nyíregyháza
Hungary	Szent Lázár Megyei Kórház	Salgótarján	Nógrád
Hungary	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged	Csongrád
Hungary	Regia Med Kft	Szekesfehervar	Fejér
Hungary	Óbudai Egészségügyi Centrum - Zalaegerszeg	Zalaegerszeg
Hungary	Zala Megyei Szent Rafael Kórház	Zalaegerszeg	Zala
Mexico	Investigacion En Salud Y Metabolismo Sc	Chihuahua
Mexico	Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia	Durango
Mexico	Unidad de Investigación Clínica y Atención Médica HEPA	Guadalajara	Jalisco
Mexico	Medical Care and Research SA de CV	Merida	Yucatán
Mexico	EME RED Hospitalaria	Mérida	Yucatán
Mexico	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists	Mexico City	Distrito Federal
Mexico	Clínica García Flores SC	Monterrey	Nuevo León
Mexico	Eukarya PharmaSite	Monterrey	Nuevo León
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	IMED Internal Medicine Clin Trials	Monterrey	Nuevo León
Mexico	Centro Multidisciplinario de Diabetes de Pachuca	Pachuca	Hidalgo
Mexico	Centro de Atención e Investigación Cardiovascular del Potosí	San Luis Potosí
Mexico	Centro de Investigacion Cardiovascular y Metabólica	Tijuana	Baja California
Mexico	FAICIC S. de R.L. de C.V.	Veracruz
Mexico	Centro de Investigacion Medica de Occidente, S.C.	Zapopan	Jalisco
Poland	KLIMED Marek Klimkiewicz	Bialystok	Podlaskie
Poland	Ambulatorium Barbara Bazela	Elblag	Warminsko-mazurskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	Centrum Medyczne Pratia Katowice	Katowice	Slaskie
Poland	NZOZ Salvia CM	Katowice	Slaskie
Poland	Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET	Krakow	Malopolskie
Poland	Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz	Lódzkie
Poland	NBR Polska	Warszawa	Mazowieckie
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1 SUM	Zabrze	Slaskie
Puerto Rico	Clinical Research Management Group Inc. - Hospital San Cristobal	Ponce
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
Puerto Rico	Latin Clinical Trial Center	San Juan
Slovakia	MediTask	Bratislava
Slovakia	Metabol KLINIK	Bratislava	Bratislavský Kraj
Slovakia	Diab - Int	Bytca	Žilinský Kraj
Slovakia	Nemocnica s poliklinikou Lucenec	Lucenec	Banskobystrický Kraj
Slovakia	MediVet s.r.o.	Malacky	Bratislavský Kraj
Slovakia	Tatratrial s.r.o.	Rožnava	Košický Kr
Slovakia	MEDI-DIA s.r.o.	Sabinov	Prešovský Kraj
Slovakia	Areteus s.r.o.	Trebisov	Košický Kraj
Spain	Hospital Universitario de La Ribera	Alzira	Valenciana, Comunitat
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitario Reina Sofia	Cordoba	Andalucía
Spain	Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval	Ferrol	A Coruña [La Coruña]
Spain	Hospital Universitario Arnau de Vilanova de Lleida	Lleida	Lleida [Lérida]
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Andalucía
Spain	Hospital Universitari Son Espases	Palma	Balears [Baleares]
Spain	Hospital Virgen del Camino	Sanlúcar de Barrameda	Cádiz
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Quiron Infanta Luisa	Sevilla	Andalucía
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Vithas Hospital Sevilla	Seville	Sevilla
Spain	Hospital Virgen de las Montañas	Villamartin	Cádiz
United States	Pinnacle Clinical Research	Austin	Texas
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Humphreys Diabetes Center	Boise	Idaho
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	South Texas Clinical Research	Corpus Christi	Texas
United States	Valley Clinical Trials, Inc.	Covina	California
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Valley Research	Fresno	California
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	Great Lakes Clinical Trials - Gurnee	Gurnee	Illinois
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	Pacific Diabetes & Endocrine Center	Honolulu	Hawaii
United States	Brengle Family Medicine	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Jacksonville	Florida
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	Collaborative Neuroscience Research, LLC	Los Alamitos	California
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Trial Management Associates	Myrtle Beach	South Carolina
United States	Weill Cornell Medical College	New York	New York
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Advanced Research Institute	Ogden	Utah
United States	Charter Research - Winter Park	Orlando	Florida
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Velocity Clinical Research, Panorama City	Panorama City	California
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	UPMC Montefiore University Hospital	Pittsburgh	Pennsylvania
United States	Progressive Medical Research	Port Orange	Florida
United States	Rainier Clinical Research Center	Renton	Washington
United States	Rochester Clinical Research, LLC	Rochester	New York
United States	Texas Diabetes & Endocrinology, P.A.	Round Rock	Texas
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Sleep Therapy Research Center	San Antonio	Texas
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Tribe Clinical Research - Spartanburg	Spartanburg	South Carolina
United States	Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative	Springfield	Illinois
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	IMA Clinical Research Warren	Warren	New Jersey
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Hungary,  Mexico,  Poland,  Puerto Rico,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Body Weight		Baseline, Week 80
Secondary	Change from Baseline in Body Mass Index (BMI)		Baseline, Week 80
Secondary	Change from Baseline in Waist Circumference		Baseline, Week 80
Secondary	Percent Change from Baseline in Total Cholesterol		Baseline, Week 80
Secondary	Percent Change from Baseline in Triglycerides		Baseline, Week 80
Secondary	Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 80
Secondary	Change from Baseline in Diastolic Blood Pressure (DBP)		Baseline, Week 80
Secondary	Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 80
Secondary	Percent Change from Baseline in Fasting Insulin		Baseline, Week 80
Secondary	Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score		Baseline, Week 80
Secondary	Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)	AUC is presented as a single average measure of AUC across the study duration.	Baseline to Week 80

External Links

•   A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3)