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

NCT ID: NCT05882045

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Retatrutide Dose 1

Participants will receive retatrutide subcutaneously (SC).

Group Type EXPERIMENTAL

Retatrutide

Intervention Type DRUG

Administered SC

Retatrutide Dose 2

Participants will receive retatrutide SC.

Group Type EXPERIMENTAL

Retatrutide

Intervention Type DRUG

Administered SC

Placebo

Participants will receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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Retatrutide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3437943

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Site Status

Valley Clinical Trials, Inc.

Covina, California, United States

Site Status

Neuro-Pain Medical Center

Fresno, California, United States

Site Status

Valley Research

Fresno, California, United States

Site Status

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Site Status

Velocity Clinical Research, Westlake

Los Angeles, California, United States

Site Status

Valley Clinical Trials, Inc.

Northridge, California, United States

Site Status

Velocity Clinical Research, Panorama City

Van Nuys, California, United States

Site Status

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Site Status

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

Charter Research - Winter Park

Orlando, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States

Site Status

Elite Clinical Trials

Blackfoot, Idaho, United States

Site Status

Humphreys Diabetes Center

Boise, Idaho, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Great Lakes Clinical Trials - Gurnee

Gurnee, Illinois, United States

Site Status

Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

Springfield, Illinois, United States

Site Status

Brengle Family Medicine

Indianapolis, Indiana, United States

Site Status

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

Site Status

MedVadis Research Corporation

Waltham, Massachusetts, United States

Site Status

StudyMetrix Research

City of Saint Peters, Missouri, United States

Site Status

Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Site Status

IMA Clinical Research Warren

Warren Township, New Jersey, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Rochester Clinical Research, LLC

Rochester, New York, United States

Site Status

Carteret Medical Group

Morehead City, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Site Status

UPMC Montefiore University Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Site Status

Trial Management Associates

Myrtle Beach, South Carolina, United States

Site Status

Tribe Clinical Research - Spartanburg

Spartanburg, South Carolina, United States

Site Status

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States

Site Status

Pinnacle Clinical Research

Austin, Texas, United States

Site Status

South Texas Clinical Research

Corpus Christi, Texas, United States

Site Status

Southern Endocrinology Associates

Mesquite, Texas, United States

Site Status

Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, United States

Site Status

Sleep Therapy Research Center

San Antonio, Texas, United States

Site Status

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status

Advanced Research Institute

Ogden, Utah, United States

Site Status

Rainier Clinical Research Center

Renton, Washington, United States

Site Status

CEDIC

CABA, Buenos Aires, Argentina

Site Status

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, Buenos Aires, Argentina

Site Status

MICA - Medicina e Investigación Cardiometabólica

Del Viso, Buenos Aires, Argentina

Site Status

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Site Status

DIM Clínica Privada

Ramos Mejía, Buenos Aires, Argentina

Site Status

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Stat Research S.A.

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Investigaciones Medicas Imoba Srl

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

Site Status

Centro Medico Privado San Vicente Diabetes

Córdoba, Córdoba Province, Argentina

Site Status

Centro de Salud e Investigaciones Médicas

Santa Rosa, La Pampa Province, Argentina

Site Status

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza Province, Argentina

Site Status

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Santa Fe Province, Argentina

Site Status

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina

Site Status

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province, Argentina

Site Status

Sanatorio San Martin

Venado Tuerto, Santa Fe Province, Argentina

Site Status

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina

Site Status

Fundación Respirar

Buenos Aires, , Argentina

Site Status

Instituto Médico DAMIC

Córdoba, , Argentina

Site Status

Centro de Investigaciones Clinicas del Litoral

Santa Fe, , Argentina

Site Status

Sanatorio Norte

Santiago del Estero, , Argentina

Site Status

Canberra Hospital

Canberra, Australian Capital Territory, Australia

Site Status

Emeritus Research

Botany, New South Wales, Australia

Site Status

Northern Beaches Clinical Research

Brookvale, New South Wales, Australia

Site Status

Camden Hospital

Camden, New South Wales, Australia

Site Status

The AIM Centre / Hunter Diabetes Centre

Merewether, New South Wales, Australia

Site Status

University of Sydney - Charles Perkins Centre

Sydney, New South Wales, Australia

Site Status

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Site Status

Core Research Group

Brisbane, Queensland, Australia

Site Status

CDH Research Institute

Maroochydore, Queensland, Australia

Site Status

Logan Hospital

Meadowbrook, Queensland, Australia

Site Status

Fusion Clinical Research

Adelaide, South Australia, Australia

Site Status

Nightingale Research

Adelaide, South Australia, Australia

Site Status

Southern Adelaide Diabetes & Endocrine Services

Mount Gambier, South Australia, Australia

Site Status

Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, South Australia, Australia

Site Status

Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

Emeritus Research

Camberwell, Victoria, Australia

Site Status

Barwon Health

Geelong, Victoria, Australia

Site Status

Austin Health - Repatriation Hospital

Heidelberg West, Victoria, Australia

Site Status

One Clinical Research

Nedlands, Western Australia, Australia

Site Status

BC Diabetes Office

Vancouver, British Columbia, Canada

Site Status

Discovery Clinical Services

Victoria, British Columbia, Canada

Site Status

Joanne F. Liutkus Medicine Professional Corporation

Cambridge, Ontario, Canada

Site Status

LMC Clinical Research Inc. (Thornhill)

Concord, Ontario, Canada

Site Status

Dr. Steven V. Zizzo Research Professional Corporation

Hamilton, Ontario, Canada

Site Status

Milestone Research Inc.

London, Ontario, Canada

Site Status

North York Diagnostic and Cardiac Centre

North York, Ontario, Canada

Site Status

Centricity Research Oshawa

Oshawa, Ontario, Canada

Site Status

Kawartha Cardiology Clinical Trials

Peterborough, Ontario, Canada

Site Status

Manna Research Toronto

Toronto, Ontario, Canada

Site Status

Ecogene-21 - Cmas

Chicoutimi, Quebec, Canada

Site Status

Ecogene-21

Chicoutimi, Quebec, Canada

Site Status

Clinique de médecine Urbaine du Quartier Latin

Montreal, Quebec, Canada

Site Status

CardioVasc HR Inc

Saint-Jean-sur-Richelieu, Quebec, Canada

Site Status

Centre de Medecine Metabolique de Lanaudiere (CMML)

Terrebonne, Quebec, Canada

Site Status

C.I.C. Mauricie inc.

Trois-Rivières, Quebec, Canada

Site Status

Syneos Health

Québec, , Canada

Site Status

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye, Hungary

Site Status

Regia Med Kft

Székesfehérvár, Fejér, Hungary

Site Status

Medifarma 98 Kft

Nyíregyháza, Nyíregyháza, Hungary

Site Status

Szent Lázár Megyei Kórház

Salgótarján, Nógrád megye, Hungary

Site Status

Óbudai Egészségügyi Centrum - Kaposvár Site

Kaposvár, Somogy County, Hungary

Site Status

DRC Gyógyszervizsgáló Központ

Balatonfüred, Veszprém megye, Hungary

Site Status

Zala Megyei Szent Rafael Kórház

Zalaegerszeg, Zala County, Hungary

Site Status

Óbudai Egészségügyi Centrum

Budapest, , Hungary

Site Status

ClinDiab Kft.

Budapest, , Hungary

Site Status

TRANTOR'99 Bt. Anyagcsere Centrum

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Központ

Debrecen, , Hungary

Site Status

Óbudai Egészségügyi Centrum - Zalaegerszeg

Zalaegerszeg, , Hungary

Site Status

Centro de Investigacion Cardiovascular y Metabólica

Tijuana, Estado de Baja California, Mexico

Site Status

Centro Multidisciplinario de Diabetes de Pachuca

Pachuca, Hidalgo, Mexico

Site Status

Unidad de Investigación Clínica y Atención Médica HEPA

Guadalajara, Jalisco, Mexico

Site Status

Centro de Investigacion Medica de Occidente, S.C.

Zapopan, Jalisco, Mexico

Site Status

RM Pharma Specialists

Mexico City, Mexico City, Mexico

Site Status

Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

Mexico City, Mexico City, Mexico

Site Status

IMED Internal Medicine Clin Trials

Monterrey, Nuevo León, Mexico

Site Status

Clínica García Flores SC

Monterrey, Nuevo León, Mexico

Site Status

Eukarya PharmaSite

Monterrey, Nuevo León, Mexico

Site Status

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Site Status

EME RED Hospitalaria

Mérida, Yucatán, Mexico

Site Status

Medical Care and Research SA de CV

Mérida, Yucatán, Mexico

Site Status

Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

Chihuahua City, , Mexico

Site Status

Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

Durango, , Mexico

Site Status

Centro de Atención e Investigación Cardiovascular del Potosí

San Luis Potosí City, , Mexico

Site Status

FAICIC S. de R.L. de C.V.

Veracruz, , Mexico

Site Status

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, Poland

Site Status

NBR Polska

Warsaw, Masovian Voivodeship, Poland

Site Status

KLIMED Marek Klimkiewicz

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Centrum Medyczne Pratia Katowice

Katowice, Silesian Voivodeship, Poland

Site Status

NZOZ Salvia CM

Katowice, Silesian Voivodeship, Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

Zabrze, Silesian Voivodeship, Poland

Site Status

Ambulatorium Sp. z o.o.

Elblag, Warmian-Masurian Voivodeship, Poland

Site Status

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Łódź Voivodeship, Poland

Site Status

Ponce Medical School Foundation Inc.

Ponce, , Puerto Rico

Site Status

Clinical Research Management Group Inc

Ponce, , Puerto Rico

Site Status

Latin Clinical Trial Center

San Juan, , Puerto Rico

Site Status

Nemocnica s poliklinikou Lucenec

Lučenec, Banská Bystrica Region, Slovakia

Site Status

Metabol KLINIK

Bratislava, Bratislava Region, Slovakia

Site Status

MediVet s.r.o.

Malacky, Bratislava Region, Slovakia

Site Status

Human Care s.r.o.

Košice, Košice Region, Slovakia

Site Status

Tatratrial s.r.o.

Rožňava, Košice Region, Slovakia

Site Status

Areteus s.r.o.

Trebišov, Košice Region, Slovakia

Site Status

MEDI-DIA s.r.o.

Sabinov, Presov, Slovakia

Site Status

MediTask

Bratislava, , Slovakia

Site Status

Diab - Int

Bytča, Žilina Region, Slovakia

Site Status

Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

Ferrol, A Coruña [La Coruña], Spain

Site Status

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Site Status

Hospital Quiron Infanta Luisa

Seville, Andalusia, Spain

Site Status

Hospital Universitari Son Espases

Palma, Balears [Baleares], Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital Virgen del Camino

Sanlúcar de Barrameda, Cádiz, Spain

Site Status

Hospital Virgen de las Montañas

Villamartín, Cádiz, Spain

Site Status

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, Lleida [Lérida], Spain

Site Status

Vithas Hospital Sevilla

Seville, Sevilla, Spain

Site Status

Hospital Universitario de La Ribera

Alzira, Valenciana, Comunitat, Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status

Countries

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

Related Links

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https://trials.lilly.com/en-US/trial/405675

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

Other Identifiers

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J1I-MC-GZBM

Identifier Type: OTHER

Identifier Source: secondary_id

2023-503659-88-00

Identifier Type: OTHER

Identifier Source: secondary_id

18582

Identifier Type: -

Identifier Source: org_study_id

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