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

July 22, 2025 updated by: Eli Lilly and Company

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Fundacion Respirar
      • Córdoba, Argentina, 5003DCE
        • Instituto Medico Damic
      • Santa Fe, Argentina, S3000FWO
        • Centro de Investigaciones Clínicas del Litoral
      • Santiago del Estero, Argentina, 4200
        • Sanatorio Norte
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1060ABN
        • CEDIC
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1056
        • Centro de Investigaciones Metabólicas (CINME)
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1012AAR
        • IDIM - Instituto de Investigaciones Metabólicas
      • Del Viso, Buenos Aires, Argentina, 1669
        • MICA - Medicina e Investigación Cardiometabólica
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto de Investigaciones Clinicas Mar del Plata
      • Ramos Mejía, Buenos Aires, Argentina, B1704ETD
        • DIM Clinica Privada
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1120AAC
        • Centro Medico Viamonte
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1056ABH
        • Investigaciones Medicas Imoba Srl
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1023AAB
        • Stat Research S.A.
      • Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, 1405
        • Consultorio de Investigación Clínica EMO SRL
    • Córdoba
      • Capital, Córdoba, Argentina, X5008HHW
        • Centro Médico Privado CEMAIC
      • Cordoba, Córdoba, Argentina, 5006
        • Centro Medico Privado San Vicente Diabetes
    • La Pampa
      • Santa Rosa, La Pampa, Argentina, 6300
        • Centro de Salud e Investigaciones Médicas
    • Mendoza
      • Godoy Cruz, Mendoza, Argentina, 5501
        • CIPADI - Centro Integral de Prevención y Atención en Diabetes
    • Santa Fe
      • Granadero Baigorria, Santa Fe, Argentina, 2152
        • Centro de Investigaciones Clinicas Baigorria
      • Rosario, Santa Fe, Argentina, 2000
        • Instituto de Investigaciones Clinicas Rosario
      • Rosario, Santa Fe, Argentina, 2000
        • INECO Neurociencias Oroño
      • Venado Tuerto, Santa Fe, Argentina, 2600
        • Sanatorio San Martin
    • Tucumán
      • SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research
      • Brookvale, New South Wales, Australia, 2100
        • Northern Beaches Clinical Research
      • Camden, New South Wales, Australia, 2570
        • Camden Hospital
      • Merewether, New South Wales, Australia, 2291
        • The AIM Centre / Hunter Diabetes Centre
      • Sydney, New South Wales, Australia, 2006
        • University of Sydney - Charles Perkins Centre
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Brisbane, Queensland, Australia, 4064
        • Core Research Group
      • Maroochydore, Queensland, Australia, 4558
        • CDH Research Institute
      • Meadowbrook, Queensland, Australia, 4131
        • Logan Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Fusion Clinical Research
      • Adelaide, South Australia, Australia, 5000
        • Nightingale Research
      • Mount Gambier, South Australia, Australia, 5290
        • Southern Adelaide Diabetes & Endocrine Services
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes & Endocrine Services
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Geelong, Victoria, Australia, 3220
        • Barwon Health
      • Heidelberg West, Victoria, Australia, 3081
        • Austin Health - Repatriation Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • One Clinical Research
  • Canada
      • Quebec, Canada, G1P0A2
        • Syneos Health
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • BC Diabetes Office
      • Victoria, British Columbia, Canada, V8T 5G4
        • Discovery Clinical Services
    • Ontario
      • Cambridge, Ontario, Canada, N3H 4L5
        • Joanne F. Liutkus Medicine Professional Corporation
      • Concord, Ontario, Canada, L4K 4M2
        • LMC Clinical Research Inc. (Thornhill)
      • Hamilton, Ontario, Canada, L8J 0B6
        • Dr. Steven V. Zizzo Research Professional Corporation
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research Inc.
      • North York, Ontario, Canada, M6B 3H7
        • North York Diagnostic and Cardiac Centre
      • Oshawa, Ontario, Canada, L1J 2K9
        • Centricity Research Oshawa
      • Peterborough, Ontario, Canada, K9J 0B2
        • Kawartha Cardiology Clinical Trials
      • Toronto, Ontario, Canada, M9W 4L6
        • Manna Research Toronto
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Chicoutimi, Quebec, Canada, G7H 0S7
        • Ecogene-21 - Cmas
      • Montreal, Quebec, Canada, H2L 4E9
        • Clinique de médecine Urbaine du Quartier Latin
      • Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
        • CardioVasc HR Inc
      • Terrebonne, Quebec, Canada, J6X 4P7
        • Centre de Medecine Metabolique de Lanaudiere (CMML)
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • C.I.C. Mauricie inc.
  • Hungary
      • Budapest, Hungary, 1036
        • Óbudai Egészségügyi Centrum
      • Budapest, Hungary, 1213
        • TRANTOR'99 Bt. Anyagcsere Centrum
      • Budapest, Hungary, 1089
        • ClinDiab Kft.
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Klinikai Kozpont
      • Zalaegerszeg, Hungary, 8900
        • Óbudai Egészségügyi Centrum - Zalaegerszeg
    • Csongrád
      • Szeged, Csongrád, Hungary, 6725
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
    • Fejér
      • Szekesfehervar, Fejér, Hungary, 8000
        • Regia Med Kft
    • Nyíregyháza
      • Nyiregyhaza, Nyíregyháza, Hungary, 4400
        • Medifarma 98 Kft
    • Nógrád
      • Salgótarján, Nógrád, Hungary, 3100
        • Szent Lazar Megyei Korhaz
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Óbudai Egészségügyi Centrum - Kaposvár Site
    • Veszprém
      • Balatonfüred, Veszprém, Hungary, 8230
        • DRC Gyógyszervizsgáló Központ
    • Zala
      • Zalaegerszeg, Zala, Hungary, 8900
        • Zala Megyei Szent Rafael Korhaz
  • Mexico
      • Chihuahua, Mexico, 31110
        • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
      • Durango, Mexico, 34000
        • Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
      • San Luis Potosí, Mexico, 78200
        • Centro de Atención e Investigación Cardiovascular del Potosí
      • Veracruz, Mexico, 91900
        • FAICIC S. de R.L. de C.V.
    • Baja California
      • Tijuana, Baja California, Mexico, 22500
        • Centro de Investigacion Cardiovascular y Metabolica
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 11650
        • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
      • Mexico City, Distrito Federal, Mexico, 03100
        • RM Pharma Specialists
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42084
        • Centro Multidisciplinario de Diabetes de Pachuca
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Unidad de Investigación Clínica y Atención Médica HEPA
      • Zapopan, Jalisco, Mexico, 44260
        • Centro de Investigacion Medica de Occidente, S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
      • Monterrey, Nuevo León, Mexico, 64060
        • IMED Internal Medicine Clin Trials
      • Monterrey, Nuevo León, Mexico, 64610
        • Clínica García Flores SC
      • Monterrey, Nuevo León, Mexico, 64718
        • Eukarya PharmaSite
    • Yucatán
      • Merida, Yucatán, Mexico, 97070
        • Medical Care and Research SA de CV
      • Mérida, Yucatán, Mexico, 97000
        • Eme Red Hospitalaria
  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-710
        • NBR Polska
    • Małopolskie
      • Krakow, Małopolskie, Poland, 31-261
        • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-704
        • KLIMED Marek Klimkiewicz
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
    • Warmińsko-mazurskie
      • Elbląg, Warmińsko-mazurskie, Poland, 82-300
        • Ambulatorium sp. z o.o.
    • Łódzkie
      • Lodz, Łódzkie, Poland, 90338
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
    • Śląskie
      • Katowice, Śląskie, Poland, 40-772
        • NZOZ Salvia CM
      • Katowice, Śląskie, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
      • Zabrze, Śląskie, Poland, 41-800
        • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
      • Ponce, Puerto Rico, 00717
        • Clinical Research Management Group Inc
      • San Juan, Puerto Rico, 00909
        • Latin Clinical Trial Center
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • MediTask
    • Banskobystrický Kraj
      • Lucenec, Banskobystrický Kraj, Slovakia, 984 01
        • Nemocnica s poliklinikou Lucenec
    • Bratislavský Kraj
      • Bratislava, Bratislavský Kraj, Slovakia, 811 08
        • Metabol KLINIK
      • Malacky, Bratislavský Kraj, Slovakia, 901 01
        • MediVet s.r.o.
    • Košický Kraj
      • Kosice, Košický Kraj, Slovakia, 04001
        • Human Care s.r.o.
      • Rožňava, Košický Kraj, Slovakia, 04801
        • Tatratrial s.r.o.
      • Trebisov, Košický Kraj, Slovakia, 075 01
        • ARETEUS s.r.o.
    • Prešovský Kraj
      • Sabinov, Prešovský Kraj, Slovakia, 083 01
        • MEDI-DIA s.r.o.
    • Žilinský Kraj
      • Bytca, Žilinský Kraj, Slovakia, 014 01
        • Diab - Int
  • Spain
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañón
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
    • A Coruña [La Coruña]
      • Ferrol, A Coruña [La Coruña], Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Malaga, Andalucía, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Sevilla, Andalucía, Spain, 41010
        • Hospital Quiron Infanta Luisa
    • Balears [Baleares]
      • Palma, Balears [Baleares], Spain, 07120
        • Hospital Universitari Son Espases
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Cádiz
      • Sanlúcar de Barrameda, Cádiz, Spain, 11540
        • Hospital Virgen del Camino
      • Villamartin, Cádiz, Spain, 11650
        • Hospital Virgen de las Montañas
    • Lleida [Lérida]
      • Lleida, Lleida [Lérida], Spain, 25198
        • Hospital Universitario Arnau de Vilanova de Lleida
    • Sevilla
      • Seville, Sevilla, Spain, 41950
        • Vithas Hospital Sevilla
    • Valenciana, Comunitat
      • Alzira, Valenciana, Comunitat, Spain, 46600
        • Hospital Universitario de La Ribera
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Central Phoenix Medical Clinic
    • California
      • Covina, California, United States, 91723
        • Valley Clinical Trials, Inc.
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • Fresno, California, United States, 93720
        • Valley Research
      • Los Alamitos, California, United States, 90720
        • Collaborative Neuroscience Research, LLC
      • Los Angeles, California, United States, 90057
        • Velocity Clinical Research, Westlake
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Van Nuys, California, United States, 91405
        • Velocity Clinical Research, Panorama City
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32803
        • Charter Research - Winter Park
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Pacific Diabetes & Endocrine Center
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
      • Boise, Idaho, United States, 83702
        • Humphreys Diabetes Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Gurnee, Illinois, United States, 60031
        • Great Lakes Clinical Trials - Gurnee
      • Springfield, Illinois, United States, 62711
        • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Brengle Family Medicine
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Tenaya
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Medical Research
    • New Jersey
      • Warren, New Jersey, United States, 07059
        • IMA Clinical Research Warren
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, LLC
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Carteret Medical Group
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Montefiore University Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
      • Myrtle Beach, South Carolina, United States, 29572
        • Trial Management Associates
      • Spartanburg, South Carolina, United States, 29301
        • Tribe Clinical Research - Spartanburg
    • Texas
      • Austin, Texas, United States, 78757
        • Pinnacle Clinical Research
      • Austin, Texas, United States, 78731
        • Texas Diabetes & Endocrinology, P.A.
      • Corpus Christi, Texas, United States, 78404
        • South Texas Clinical Research
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology, P.A.
      • San Antonio, Texas, United States, 78229
        • Sleep Therapy Research Center
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo.
Drug: Placebo
Administered SC
Experimental: Retatrutide Dose 1
Participants will receive retatrutide subcutaneously (SC).
Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943
Experimental: Retatrutide Dose 2
Participants will receive retatrutide SC.
Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 80
Baseline, Week 80

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18582
  • J1I-MC-GZBM (Other Identifier: Eli Lilly and Company)
  • 2023-503659-88-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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