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ObesityPhase 3TRIUMPH-3NCT05882045

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

A Phase 3 study testing Retatrutide in people with Obesity and Cardiovascular Diseases, run by Eli Lilly and Company at 169 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Cardiovascular Diseases
What is being tested?
Retatrutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,946 participants
Where
169 sitesin 10 countries
Study dates
30 May 2023to 14 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

169 sites in 10 countries.

169 sites in 10 countries

United States46 sites

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731

  • Pinnacle Clinical Research

    Austin, Texas, 78757

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Humphreys Diabetes Center

    Boise, Idaho, 83702

  • Northwestern University

    Chicago, Illinois, 60611

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404

  • Valley Clinical Trials, Inc.

    Covina, California, 91723

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Valley Research

    Fresno, California, 93720

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • Great Lakes Clinical Trials - Gurnee

    Gurnee, Illinois, 60031

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii, 96817

  • Brengle Family Medicine

    Indianapolis, Indiana, 46260

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California, 90720

  • Velocity Clinical Research, Westlake

    Los Angeles, California, 90057

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572

  • Weill Cornell Medical College

    New York, New York, 10021

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Charter Research - Winter Park

    Orlando, Florida, 32803

  • Central Phoenix Medical Clinic

    Phoenix, Arizona, 85020

  • UPMC Montefiore University Hospital

    Pittsburgh, Pennsylvania, 15213

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas, 78681

  • Sleep Therapy Research Center

    San Antonio, Texas, 78229

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Tribe Clinical Research - Spartanburg

    Spartanburg, South Carolina, 29301

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

    Springfield, Illinois, 62711

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

  • Velocity Clinical Research, Panorama City

    Van Nuys, California, 91405

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • IMA Clinical Research Warren

    Warren Township, New Jersey, 07059

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

Other trials in United States

Argentina24 sites

  • Fundación Respirar

    Buenos Aires, Buenos Aires, C1426ABP

  • Consultorio de Investigación Clínica EMO SRL

    Buenos Aires, Buenos Aires F.D., 1405

  • Stat Research S.A.

    Buenos Aires, Buenos Aires F.D., C1023AAB

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, Buenos Aires F.D., C1056ABH

  • Centro Médico Viamonte

    Buenos Aires, Buenos Aires F.D., C1120AAC

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, Buenos Aires F.D., C1425AGC

  • CEDIC

    CABA, Buenos Aires, C1060ABN

  • Centro Medico Privado CEMAIC

    Capital, Córdoba Province, X5008HHW

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056

  • IDIM - Instituto de Investigaciones Metabólicas

    Ciudad de Buenos Aires, Buenos Aires, C1012AAR

  • Instituto Médico DAMIC

    Córdoba, Córdoba Province, 5003DCE

  • Centro Medico Privado San Vicente Diabetes

    Córdoba, Córdoba Province, 5006

  • MICA - Medicina e Investigación Cardiometabólica

    Del Viso, Buenos Aires, 1669

  • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

    Godoy Cruz, Mendoza Province, 5501

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, Santa Fe Province, 2152

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

  • DIM Clínica Privada

    Ramos Mejía, Buenos Aires, B1704ETD

  • INECO Neurociencias Oroño

    Rosario, Santa Fe Province, 2000

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe Province, 2000

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province, T4000AXL

  • Centro de Investigaciones Clinicas del Litoral

    Santa Fe, Santa Fe Province, S3000FWO

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, La Pampa Province, 6300

  • Sanatorio Norte

    Santiago del Estero, Santiago del Estero Province, 4200

  • Sanatorio San Martin

    Venado Tuerto, Santa Fe Province, 2600

Other trials in Argentina

Australia19 sites

  • Fusion Clinical Research

    Adelaide, South Australia, 5000

  • Nightingale Research

    Adelaide, South Australia, 5000

  • Emeritus Research

    Botany, New South Wales, 2019

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Core Research Group

    Brisbane, Queensland, 4064

  • Northern Beaches Clinical Research

    Brookvale, New South Wales, 2100

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Camden Hospital

    Camden, New South Wales, 2570

  • Canberra Hospital

    Canberra, Australian Capital Territory, 2605

  • Barwon Health

    Geelong, Victoria, 3220

  • Austin Health - Repatriation Hospital

    Heidelberg West, Victoria, 3081

  • CDH Research Institute

    Maroochydore, Queensland, 4558

  • Logan Hospital

    Meadowbrook, Queensland, 4131

  • The AIM Centre / Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • Southern Adelaide Diabetes & Endocrine Services

    Mount Gambier, South Australia, 5290

  • One Clinical Research

    Nedlands, Western Australia, 6009

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, South Australia, 5046

  • University of Sydney - Charles Perkins Centre

    Sydney, New South Wales, 2006

Other trials in Australia

Canada17 sites

  • Joanne F. Liutkus Medicine Professional Corporation

    Cambridge, Ontario, N3H 4L5

  • Ecogene-21 - Cmas

    Chicoutimi, Quebec, G7H 0S7

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • LMC Clinical Research Inc. (Thornhill)

    Concord, Ontario, L4K 4M2

  • Dr. Steven V. Zizzo Research Professional Corporation

    Hamilton, Ontario, L8J 0B6

  • Milestone Research Inc.

    London, Ontario, N5W 6A2

  • Clinique de médecine Urbaine du Quartier Latin

    Montreal, Quebec, H2L 4E9

  • North York Diagnostic and Cardiac Centre

    North York, Ontario, M6B 3H7

  • Centricity Research Oshawa

    Oshawa, Ontario, L1J 2K9

  • Kawartha Cardiology Clinical Trials

    Peterborough, Ontario, K9J 0B2

  • Syneos Health

    Québec, Quebec, G1P0A2

  • CardioVasc HR Inc

    Saint-Jean-sur-Richelieu, Quebec, J3A 1J2

  • Centre de Medecine Metabolique de Lanaudiere (CMML)

    Terrebonne, Quebec, J6X 4P7

  • Manna Research Toronto

    Toronto, Ontario, M9W 4L6

  • C.I.C. Mauricie inc.

    Trois-Rivières, Quebec, G8T 7A1

  • BC Diabetes Office

    Vancouver, British Columbia, V5Y 3W2

  • Discovery Clinical Services

    Victoria, British Columbia, V8T 5G4

Other trials in Canada

Mexico16 sites

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

    Chihuahua City, Chihuahua, 31110

  • Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

    Durango, Durango, 34000

  • Unidad de Investigación Clínica y Atención Médica HEPA

    Guadalajara, Jalisco, 44670

  • EME RED Hospitalaria

    Mérida, Yucatán, 97000

  • Medical Care and Research SA de CV

    Mérida, Yucatán, 97070

  • RM Pharma Specialists

    Mexico City, Mexico City, 03100

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, Mexico City, 11650

  • IMED Internal Medicine Clin Trials

    Monterrey, Nuevo León, 64060

  • Clínica García Flores SC

    Monterrey, Nuevo León, 64610

  • Eukarya PharmaSite

    Monterrey, Nuevo León, 64718

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460

  • Centro Multidisciplinario de Diabetes de Pachuca

    Pachuca, Hidalgo, 42084

  • Centro de Atención e Investigación Cardiovascular del Potosí

    San Luis Potosí City, San Luis Potosí, 78200

  • Centro de Investigacion Cardiovascular y Metabólica

    Tijuana, Estado de Baja California, 22500

  • FAICIC S. de R.L. de C.V.

    Veracruz, Veracruz, 91900

  • Centro de Investigacion Medica de Occidente, S.C.

    Zapopan, Jalisco, 44260

Other trials in Mexico

Spain14 sites

  • Hospital Universitario de La Ribera

    Alzira, Valenciana, Comunitat, 46600

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

    Ferrol, A Coruña [La Coruña], 15405

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, Lleida [Lérida], 25198

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, 28009

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

  • Hospital Universitari Son Espases

    Palma, Balears [Baleares], 07120

  • Hospital Virgen del Camino

    Sanlúcar de Barrameda, Cádiz, 11540

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Quiron Infanta Luisa

    Seville, Andalusia, 41010

  • Hospital Universitario Virgen Del Rocio

    Seville, Sevilla, 41013

  • Vithas Hospital Sevilla

    Seville, Sevilla, 41950

  • Hospital Virgen de las Montañas

    Villamartín, Cádiz, 11650

Other trials in Spain

Hungary12 sites

  • DRC Gyógyszervizsgáló Központ

    Balatonfüred, Veszprém megye, 8230

  • Óbudai Egészségügyi Centrum

    Budapest, Budapest, 1036

  • ClinDiab Kft.

    Budapest, Budapest, 1089

  • TRANTOR'99 Bt. Anyagcsere Centrum

    Budapest, Budapest, 1213

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Debrecen, 4031

  • Óbudai Egészségügyi Centrum - Kaposvár Site

    Kaposvár, Somogy County, 7400

  • Medifarma 98 Kft

    Nyíregyháza, Nyíregyháza, 4400

  • Szent Lázár Megyei Kórház

    Salgótarján, Nógrád megye, 3100

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád megye, 6725

  • Regia Med Kft

    Székesfehérvár, Fejér, 8000

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, Zala County, 8900

  • Óbudai Egészségügyi Centrum - Zalaegerszeg

    Zalaegerszeg, Zalaegerszeg, 8900

Other trials in Hungary

Poland9 sites

  • KLIMED Marek Klimkiewicz

    Bialystok, Podlaskie Voivodeship, 15-704

  • Ambulatorium Sp. z o.o.

    Elblag, Warmian-Masurian Voivodeship, 82-300

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

    Gdansk, Pomeranian Voivodeship, 80-546

  • Centrum Medyczne Pratia Katowice

    Katowice, Silesian Voivodeship, 40-081

  • NZOZ Salvia CM

    Katowice, Silesian Voivodeship, 40-772

  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

    Krakow, Lesser Poland Voivodeship, 31-261

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

    Lodz, Łódź Voivodeship, 90338

  • NBR Polska

    Warsaw, Masovian Voivodeship, 00-710

  • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

    Zabrze, Silesian Voivodeship, 41-800

Other trials in Poland

Slovakia9 sites

  • Metabol KLINIK

    Bratislava, Bratislava Region, 811 08

  • MediTask

    Bratislava, 831 03

  • Diab - Int

    Bytča, Žilina Region, 014 01

  • Human Care s.r.o.

    Košice, Košice Region, 04001

  • Nemocnica s poliklinikou Lucenec

    Lučenec, Banská Bystrica Region, 984 01

  • MediVet s.r.o.

    Malacky, Bratislava Region, 901 01

  • Tatratrial s.r.o.

    Rožňava, Košice Region, 04801

  • MEDI-DIA s.r.o.

    Sabinov, Presov, 083 01

  • Areteus s.r.o.

    Trebišov, Košice Region, 075 01

Other trials in Slovakia

Puerto Rico3 sites

  • Ponce Medical School Foundation Inc.

    Ponce, 00716

  • Clinical Research Management Group Inc

    Ponce, 00717

  • Latin Clinical Trial Center

    San Juan, 00909

Other trials in Puerto Rico

About this study

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

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.

Being tested
Retatrutide, Placebo
Medical subject headings
Obesity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetatrutideDrug

    Also called LY3437943

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT05882045
Study groupRoleWhat they receive
Retatrutide Dose 1ExperimentalParticipants will receive retatrutide subcutaneously (SC).
Receives: Drug: Retatrutide
Retatrutide Dose 2ExperimentalParticipants will receive retatrutide SC.
Receives: Drug: Retatrutide
PlaceboPlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 80

Secondary outcomes (10)

  1. Change from Baseline in Body Mass Index (BMI)

    Measured: Baseline, Week 80

  2. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 80

  3. Percent Change from Baseline in Total Cholesterol

    Measured: Baseline, Week 80

  4. Percent Change from Baseline in Triglycerides

    Measured: Baseline, Week 80

  5. Change from Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 80

  6. Change from Baseline in Diastolic Blood Pressure (DBP)

    Measured: Baseline, Week 80

  7. Change from Baseline in Hemoglobin A1c (HbA1c)

    Measured: Baseline, Week 80

  8. Percent Change from Baseline in Fasting Insulin

    Measured: Baseline, Week 80

  9. Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score

    Measured: Baseline, Week 80

  10. 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.

    Measured: Baseline to Week 80

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start30 May 2023
  3. Primary completion16 Apr 2026
  4. Study completion14 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,946 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05882045
Sponsor's protocol ID
18582
Other IDs
J1I-MC-GZBM, 2023-503659-88-00, 2023
Acronym
TRIUMPH-3
Status last verified
Jul 2026
First submitted
22 May 2023
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retatrutide in people with Obesity and Cardiovascular Diseases, run by Eli Lilly and Company at 169 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, Argentina, Australia, Canada, Mexico and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Body Weight (time frame: Baseline, Week 80). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05882045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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