A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (TRIUMPH-1)

June 2, 2026 updated by: Eli Lilly and Company

A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2335

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

  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research
      • Merewether, New South Wales, Australia, 2291
        • The AIM Centre / Hunter Diabetes Centre
    • Queensland
      • Meadowbrook, Queensland, Australia, 4131
        • Logan Hospital
    • South Aust
      • Adelaide, South Aust, Australia, 5000
        • Nightingale Research
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Fusion Clinical Research
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Geelong, Victoria, Australia, 3220
        • Barwon Health
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • One Clinical Research
  • Brazil
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigacao Clinica
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01228-200
        • CPCLIN
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates Limited
      • Hamilton, Ontario, Canada, L8L 5G8
        • Wharton Medical Clinic
      • Hamilton, Ontario, Canada, L8J 0B6
        • Dr. Steven V. Zizzo Medicine Professional Corporation
      • Niagara Falls, Ontario, Canada, L2H 1H5
        • Your Research Network
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
      • Toronto, Ontario, Canada, M3J 0K2
        • Canadian Phase Onward
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Centre de Recherche Clinique de Laval
      • Montreal, Quebec, Canada, H2L 4E9
        • Clinique de médecine Urbaine du Quartier Latin
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • C.I.C. Mauricie inc.
  • Hungary
      • Budapest, Hungary, 1036
        • Óbudai Egészségügyi Centrum
      • Budapest, Hungary, 1089
        • ClinDiab Kft.
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Klinikai Kozpont
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
    • Fejér
      • Székesfehérvár, Fejér, Hungary, 8000
        • Regia Med Kft
    • Nyíregyháza
      • Nyíregyháza, Nyíregyháza, Hungary, 4400
        • Medifarma 98 Kft
    • Veszprém megye
      • Balatonfüred, Veszprém megye, Hungary, 8230
        • DRC Gyógyszervizsgáló Központ
  • India
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Endolife Speciality Hospitals
    • Gujarat
      • Ahmedabad, Gujarat, India, 380013
        • Avron Hospitals
      • Surat, Gujarat, India, 395002
        • Surat Institute of Digestive Sciences Hospitals
    • Karnataka
      • Hubli, Karnataka, India, 580021
        • Karnataka Institute of Medical Sciences
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695031
        • Indian Institute of Diabetes
      • Trivandrum, Kerala, India, 695032
        • Jothydev's Diabetes and Research Center
    • Maharashtra
      • Mumbai, Maharashtra, India, 400011
        • Wockhardt Hospital - Mumbai Central
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
      • Pune, Maharashtra, India, 411057
        • Lifepoint Multispeciality Hospital
      • Pune, Maharashtra, India, 411021
        • Chellaram Diabetes Institute
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • All India Institute of Medical Sciences
    • Rajasthan
      • Jaipur, Rajasthan, India, 302020
        • Eternal Heart Care Center and Research Institute
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College Vellore
    • West Benga
      • Kolkata, West Benga, India, 700064
        • ILS Hospitals
  • Mexico
      • Aguascalientes, Mexico, 20119
        • Centro de Atención e Investigación Clínica
      • Chihuahua City, Mexico, 31110
        • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
      • Veracruz, Mexico, 91910
        • Arké SMO S.A de C.V
    • Estado de Baja California
      • Mexicali, Estado de Baja California, Mexico, 21200
        • Centro de Investigacion en Artritis y Osteoporosis SC
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Diseno y Planeacion en Investigacion Medica
      • Guadalajara, Jalisco, Mexico, 44670
        • Unidad de Investigación Clínica y Atención Médica HEPA
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S. C.
      • Guadalajara, Jalisco, Mexico, 44670
        • Private Practice - Dr. Arechavaleta Granell Maria del Rosario
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03100
        • RM Pharma Specialists
      • Mexico City, Mexico City, Mexico, 06700
        • Clinica Omega
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Instituto de Diabetes, Obesidad y Nutricion
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Unidad Biomédica Avanzada Monterrey
      • Monterrey, Nuevo León, Mexico, 66460
        • Hospital Universitario Dr. Jose Eleuterio Gonzalez
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • Eme Red Hospitalaria
      • Mérida, Yucatán, Mexico, 97070
        • Kohler and Milstein Research S.A. de C.V.
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-589
        • Centrum Zdrowia Metabolicznego Pawel Bogdanski
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-605
        • Intercor
    • Lesser Poland Voivodeship
      • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
        • Private Practice - Dr. Robert Witek
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-044
        • CenterMed Lublin NZOZ
      • Lublin, Lublin Voivodeship, Poland, 20-333
        • Gabinety TERPA
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-874
        • MICS Centrum Medyczne Warszawa
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny W Białymstoku
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-772
        • NZOZ Salvia CM
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Ambulatorium sp. z o.o.
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Centrum Kliniczno-Badawcze
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-355
        • Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
  • Romania
      • Bacau, Romania, 600274
        • SC Minimed SRL
      • Galați, Romania, 800291
        • Diamed Obesity
      • Iași, Romania, 700547
        • Centrul Medical Consultmed
      • Satu Mare, Romania, 440055
        • Clinica Korall
      • Sibiu, Romania, 550371
        • Policlinica Astra Sibiu
    • Bihor County
      • Oradea, Bihor County, Romania, 410147
        • Diabdana
    • Brașov County
      • Brasov, Brașov County, Romania, 500283
        • C.M.D.T.A. Neomed
    • Bucharest
      • Bucharest, Bucharest, Romania, 011053
        • Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
    • Constanța County
      • Mangalia, Constanța County, Romania, 905500
        • Gama Diamed
    • Timiș County
      • Timișoara, Timiș County, Romania, 300288
        • Cabinet Medical Dr.Geru
  • Spain
      • Seville, Spain, 41003
        • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña
      • Ferrol, A Coruña [La Coruña], Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Hospital General Universitario de Valencia
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Heartlands Hospital
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospital NHS Foundation Trust
      • Penzance, United Kingdom, TR18 3DX
        • St Clare Medical Centre
      • Sheffield, United Kingdom, S2 5FX
        • Panthera Biopartners - Sheffield
    • England
      • Chippenham, England, United Kingdom, SN15 2SB
        • Rowden Surgery
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 7EN
        • Layton Medical Centre
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Leicester General Hospital
    • London, City of
      • Enfield, London, City of, United Kingdom, EN3 4GS
        • Panthera Biopartners - North London
    • Scotland
      • Glasgow, Scotland, United Kingdom, G31 2ER
        • Glasgow Royal Infirmary
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85020
        • Central Phoenix Medical Clinic
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Medical Investigations
    • California
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • Fresno, California, United States, 93720
        • Valley Research
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University School of Medicine
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Brandon, Florida, United States, 33511
        • Teradan Clinical Trials, LLC
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • Miami, Florida, United States, 33135
        • Suncoast Research Group
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • NeuroTrials Research Inc
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • 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
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Tenaya
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, LLC
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Carteret Medical Group
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates - Wilmington - Floral Parkway
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
      • Spartanburg, South Carolina, United States, 29301
        • Tribe Clinical Research - Spartanburg
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt Health One Hundred Oaks
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
      • Houston, Texas, United States, 77040
        • Juno Research
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • 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 body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:

    • hypertension
    • dyslipidemia
    • obstructive sleep apnea, or
    • cardiovascular disease
  • History of of at least one unsuccessful dietary effort to reduce body weight

GOA1 Inclusion Criteria:

  • Have index knee pain for >12 weeks prior to screening, and presence of index knee pain for >15 days over the previous month
  • Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening
  • Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.

GSA1 Inclusion Criteria:

  • Previously diagnosed with OSA
  • Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
  • For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
  • If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.

GZBJ Addenda (2) inclusion criteria:

  • Have completed the final treatment visit of GZBJ Week 80.

Exclusion Criteria:

  • Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days.
  • Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
  • Have a prior or planned surgical treatment for obesity.
  • Have diabetes mellitus.
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Have had pancreatitis.

GOA1 exclusion criteria

  • Have had steroid joint injections within 90 days of screening.
  • Have had other joint injections and procedures within 6 months of screening.
  • Have joint disease other than osteoarthritis.

GSA1 exclusion criteria

  • Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
  • Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
  • Use a dental appliance or other device to treat OSA other than PAP therapy.

GZBJ Addenda (2) exclusion criteria

  • Have had study intervention discontinuation.
  • Have had permanent dose reduction.

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
Experimental: Retatrutide Dose 3
Participants will receive retatrutide SC.
Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943
Experimental: Retatrutide Extension Period
Participants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.
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
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset
Time Frame: Baseline, Week 80
Baseline, Week 80
Percent Change from Baseline in Body Weight to
Time Frame: Baseline, Week 104
Baseline, Week 104

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
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time Frame: Baseline, Week 80
Baseline, Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Time Frame: Baseline through Week 80
AUC is presented as a single average measure of AUC across the study duration.
Baseline through Week 80
Percent Change form Baseline in Fasting Insulin
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in HbA1c
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset
Time Frame: Baseline, Week 80
Baseline, Week 80
Percent Change from Baseline in AHI for GSA1 Subset
Time Frame: Baseline, Week 80
Baseline, Week 80
A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA1 Subset
Time Frame: Baseline to Week 80
A hierarchical combination of change from baseline in the FOSQ 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.
Baseline to Week 80
Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA1 Subset
Time Frame: Baseline to Week 80
Baseline to Week 80
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA1 Subset
Time Frame: Week 80
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)

July 10, 2023

Primary Completion (Actual)

April 6, 2026

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18557
  • J1I-MC-GZBJ (Other Identifier: Master Protocol Eli Lilly and Company)
  • J1I-MC-GOA1 (Other Identifier: ISA Eli Lilly and Company)
  • J1I-MC-GSA1 (Other Identifier: ISA Eli Lilly and Company)
  • 2023-503657-35-00 (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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