ClinicalTrials.gov
History of Changes for Study: NCT05882045
A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3)
Latest version (submitted April 15, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 22, 2023 None (earliest Version on record)
2 June 11, 2023 Recruitment Status, Contacts/Locations, Study Status and Oversight
3 July 1, 2023 Contacts/Locations and Study Status
4 July 10, 2023 References, Contacts/Locations and Study Status
5 July 28, 2023 Study Status
6 September 1, 2023 Contacts/Locations and Study Status
7 October 9, 2023 Contacts/Locations and Study Status
8 October 18, 2023 Contacts/Locations and Study Status
9 March 11, 2024 Contacts/Locations and Study Status
10 April 15, 2024 Contacts/Locations and Study Status
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Study NCT05882045
Submitted Date:  May 22, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: 18582
Brief Title: A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (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
Secondary IDs: J1I-MC-GZBM [Eli Lilly and Company]
2023-503659-88-00 [EU Trial Number]
Open or close this module Study Status
Record Verification: May 2023
Overall Status: Not yet recruiting
Study Start: June 30, 2023
Primary Completion: January 20, 2026 [Anticipated]
Study Completion: February 17, 2026 [Anticipated]
First Submitted: May 22, 2023
First Submitted that
Met QC Criteria:		 May 22, 2023
First Posted: May 31, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 May 22, 2023
Last Update Posted: May 31, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Eli Lilly and Company
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
Detailed Description:
Open or close this module Conditions
Conditions: Obesity
Cardiovascular Diseases
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 1800 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Placebo Comparator: Placebo
Participants will receive placebo.
 Drug: Placebo
Administered SC
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percent Change from Baseline in Body Weight
[ Time Frame: Baseline, Week 80 ]
Secondary Outcome Measures:
1. Change from Baseline in Body Mass Index (BMI)
[ Time Frame: Baseline, Week 80 ]
2. Change from Baseline in Waist Circumference
[ Time Frame: Baseline, Week 80 ]
3. Percent Change from Baseline in Total Cholesterol
[ Time Frame: Baseline, Week 80 ]
4. Percent Change from Baseline in Triglycerides
[ Time Frame: Baseline, Week 80 ]
5. Change from Baseline in Systolic Blood Pressure (SBP)
[ Time Frame: Baseline, Week 80 ]
6. Change from Baseline in Diastolic Blood Pressure (DBP)
[ Time Frame: Baseline, Week 80 ]
7. Change from Baseline in Hemoglobin A1c (HbA1c)
[ Time Frame: Baseline, Week 80 ]
8. Percent Change from Baseline in Fasting Insulin
[ Time Frame: Baseline, Week 80 ]
9. Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score
[ Time Frame: Baseline, Week 80 ]
10. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: There may be multiple sites in this clinical trial -877-CTLILLY (1-877-285-4559) or
Telephone: 1-317-615-4559
Email: ClinicalTrials.gov@lilly.com
Study Officials: 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)
Study Director
Eli Lilly and Company
Locations: United States, Arizona
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85020
Contact:Contact: 602-200-3814
Contact:Principal Investigator: Elysa Shaw
United States, California
Valley Clinical Trials, Inc.
Covina, California, United States, 91723
Contact:Contact: 626-598-4952
Contact:Principal Investigator: Fahed G Bitar
Valley Research
Fresno, California, United States, 93720
Contact:Contact: 5592610992
Contact:Principal Investigator: Paul Carlton Norwood
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States, 90720
Contact:Contact: 714-799-7799
Contact:Principal Investigator: Steven H. Reynolds
Velocity Clinical Research, Westlake
Los Angeles, California, United States, 90057
Contact:Contact: 2134132500
Contact:Principal Investigator: Juan Pablo Frias
Valley Clinical Trials, Inc.
Northridge, California, United States, 91325
Contact:Contact: 818-280-4220
Contact:Principal Investigator: Christopher Chow
Velocity Clinical Research, Panorama City
Panorama City, California, United States, 91402
Contact:Contact: 8185326880
Contact:Principal Investigator: Robert Allen Jenders
United States, Connecticut
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
Contact:Contact: 203-419-4420
Contact:Principal Investigator: Joseph Soufer
United States, Florida
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States, 32256
Contact:Contact: 9042815757
Contact:Principal Investigator: John Mark Joyce
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
Contact:Contact: 4074255100
Contact:Principal Investigator: Michael Edward Dever
Progressive Medical Research
Port Orange, Florida, United States, 32127
Contact:Contact: 386-304-7070
Contact:Principal Investigator: Richard Mohammed
Charter Research - Winter Park
Winter Park, Florida, United States, 32792
Contact:Contact: 407-337-1000
Contact:Principal Investigator: Edgardo J Rivera-Rivera
United States, Hawaii
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States, 96813
Contact:Contact: 808-526-0303
Contact:Principal Investigator: ALAN PARSA
United States, Idaho
Elite Clinical Trials
Blackfoot, Idaho, United States, 83221
Contact:Contact: 208-643-0006
Contact:Principal Investigator: Gary W Soucie
Humphreys Diabetes Center
Boise, Idaho, United States, 83702
Contact:Contact: 208-385-4063
Contact:Principal Investigator: Sherwin C D'Souza
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Contact:Contact: 312-503-2315
Contact:Principal Investigator: Thomas Schnitzer
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois, United States, 60031
Contact:Principal Investigator: Yevgeniy Bukhman
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, United States, 62711
Contact:Contact: 217-546-2064
Contact:Principal Investigator: Diana Widicus
United States, Indiana
Brengle Family Medicine
Indianapolis, Indiana, United States, 46260
Contact:Contact: 317-252-1219
Contact:Principal Investigator: Blair Brengle
United States, Iowa
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States, 50265
Contact:Contact: 515-329-6800
Contact:Principal Investigator: Anuj Bhargava
United States, Kansas
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
Contact:Contact: 7853680428
Contact:Principal Investigator: Alan Glenn Wynne
United States, Massachusetts
MedVadis Research Corporation
Waltham, Massachusetts, United States, 02451
Contact:Contact: 617-744-1310
Contact:Principal Investigator: David DiBenedetto
United States, Missouri
StudyMetrix Research
Saint Peters, Missouri, United States, 63303
Contact:Principal Investigator: Timothy R Smith
United States, Nevada
Las Vegas Medical Research
Las Vegas, Nevada, United States, 89113
Contact:Contact: 702-750-0222
Contact:Principal Investigator: Bharat R Mocherla
Palm Research Center Tenaya
Las Vegas, Nevada, United States, 89128
Contact:Contact: 702-736-5161
Contact:Principal Investigator: Samer Nakhle
United States, New Jersey
Amici Clinical Research LLC
Warren, New Jersey, United States, 07059
Contact:Contact: 7323699402
Contact:Principal Investigator: Robert Stephen Falcone
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Contact:Contact: 646-962-2111
Contact:Principal Investigator: Louis J Aronne
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
Contact:Contact: 5852880890
Contact:Principal Investigator: Matthew Gilruth Davis
United States, North Carolina
Carteret Medical Group
Morehead City, North Carolina, United States, 28557
Contact:Contact: 2524998623
Contact:Principal Investigator: Mary Katherine Lawrence
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact:Principal Investigator: Winfield Scott BUTSCH
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
Contact:Contact: 8146930300
Contact:Principal Investigator: Alan Jan Kivitz
University of Pittsburgh Medical Center Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Contact:Principal Investigator: Anita Courcoulas
UPMC Montefiore University Hospital
Pittsburgh, Pennsylvania, United States, 15213
Contact:Principal Investigator: Anita Courcoulas
United States, South Carolina
Tribe Clinical Research, LLC
Greenville, South Carolina, United States, 29607
Contact:Contact: 8643340141
Contact:Principal Investigator: Ronald Keith Mayfield
Trial Management Associates
Myrtle Beach, South Carolina, United States, 29572
Contact:Contact: 843497592973
Contact:Principal Investigator: Donald Charles Eagerton
Tribe Clinical Research - Spartanburg
Spartanburg, South Carolina, United States, 29301
Contact:Principal Investigator: Christopher Michael Davis
United States, Texas
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States, 78731
Contact:Contact: 512-334-3505
Contact:Principal Investigator: Thomas Blevins
Pinnacle Clinical Research
Austin, Texas, United States, 78757
Contact:Contact: 512-384-1560
Contact:Principal Investigator: Jacques Benun
Southern Endocrinology Associates
Mesquite, Texas, United States, 75149
Contact:Contact: 214-693-0904
Contact:Principal Investigator: Sumana Gangi
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, United States, 78681
Contact:Contact: 512-334-3505
Contact:Principal Investigator: Hien Tran
Sleep Therapy Research Center
San Antonio, Texas, United States, 78229
Contact:Principal Investigator: Nagwa Lamaie
Consano Clinical Research, LLC
Shavano Park, Texas, United States, 78231
Contact:Contact: 210-545-4900
Contact:Principal Investigator: Michelle Welch
United States, Utah
Advanced Research Institute
Ogden, Utah, United States, 84405
Contact:Contact: 801-409-2040
Contact:Principal Investigator: Michael D Woolman
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Contact:Contact: 4252511720
Contact:Principal Investigator: Frances Eileen Broyles
Argentina
Fundación Respirar
Buenos Aires, Argentina, C1426ABP
Contact:Contact: 541170781548
Contact:Principal Investigator: Marina Paula Uhrig
Instituto Médico DAMIC
Córdoba, Argentina, 5003DCE
Contact:Contact: 5493516140705
Contact:Principal Investigator: Adriana Alicia Villarino
Centro de Investigaciones Clinicas del Litoral
Santa Fe, Argentina, S3000FWO
Contact:Contact: 5403424562779
Contact:Principal Investigator: Miguel Hominal
Argentina, Buenos Aires
CEDIC
Caba, Buenos Aires, Argentina, C1060ABN
Contact:Contact: 541148236838
Contact:Principal Investigator: Elizabeth Gelersztein
Consultorio de Investigación Clínica EMO SRL
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1405
Contact:Contact: 5491157417654
Contact:Principal Investigator: Pablo Rene Costanzo
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1056
Contact:Contact: 00541150319914
Contact:Principal Investigator: Federico C. Perez Manghi
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1012AAR
Contact:Contact: 5491169680411
Contact:Principal Investigator: María Florencia Scioscia
MICA - Medicina e Investigación Cardiometabólica
Del Viso, Buenos Aires, Argentina, 1669
Contact:Contact: 541138459542
Contact:Principal Investigator: Micaela Mirada
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina, 7600
Contact:Contact: 542234963224
Contact:Principal Investigator: Virginia L. Sernia
DIM Clínica Privada
Ramos Mejía, Buenos Aires, Argentina, B1704ETD
Contact:Contact: 5401146562828
Contact:Principal Investigator: Oscar Romano Montaña
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, Argentina, B2800DGH
Contact:Contact: 03487431654
Contact:Principal Investigator: Virginia Durigan
Argentina, Ciudad Aut
Stat Research S.A.
Buenos Aires, Ciudad Aut, Argentina, C1023AAB
Contact:Contact: 54114816673
Contact:Principal Investigator: Lucas Lisandro Gutnisky
Centro Médico Viamonte
Buenos Aires, Ciudad Aut, Argentina, C1120AAC
Contact:Contact: 541149635650
Contact:Principal Investigator: Diego Aizenberg
Argentina, Ciudad Autónoma De Buenos Aire
Investigaciones Medicas Imoba Srl
Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, C1179AAB
Contact:Contact: 541149831589
Contact:Principal Investigator: Silvia Ines Orio
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, Argentina, C1425AGC
Contact:Contact: 541148019001
Contact:Principal Investigator: Maria Jimena Coronel
Argentina, Córdoba
Centro Medico Privado CEMAIC
Capital, Córdoba, Argentina, X5008HHW
Contact:Contact: 5403514766837
Contact:Principal Investigator: Lucrecia Nardone
Centro Medico Privado San Vicente Diabetes
Cordoba, Córdoba, Argentina, 5006
Contact:Contact: 3514584601
Contact:Principal Investigator: Cecilia M. Luquez
Argentina, La Pampa
Centro de Salud e Investigaciones Médicas
Santa Rosa, La Pampa, Argentina, 6300
Contact:Contact: 542954244444
Contact:Principal Investigator: Marcos Alejandro Mayer
Argentina, Mendoza
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz, Mendoza, Argentina, 5501
Contact:Contact: 542614200345
Contact:Principal Investigator: Pedro Rosario Fabian Calella
Argentina, Santa Fe
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, Santa Fe, Argentina, 2152
Contact:Contact: 543415593898
Contact:Principal Investigator: Juan Pablo Escalante
INECO Neurociencias Oroño
Rosario, Santa Fe, Argentina, 2000
Contact:Contact: 5493415597777
Contact:Principal Investigator: Marisa Liliana Vico
Instituto de Investigaciones Clinicas Rosario
Rosario, Santa Fe, Argentina, 2000
Contact:Contact: 5493415109204
Contact:Principal Investigator: Carolina Viviana Chacón
Sanatorio San Martin
Venado Tuerto, Santa Fe, Argentina, 2600
Contact:Contact: 543462420042
Contact:Principal Investigator: Oscar Gomez Vilamajo
Argentina, Santiago D
Sanatorio Norte
Santiago del Estero, Santiago D, Argentina, 4200
Contact:Contact: 0384154125573
Contact:Principal Investigator: Franklin Hector Abalos
Argentina, Tucumán
Centro de Investigaciones Médicas Tucuman
San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
Contact:Contact: 543814200180
Contact:Principal Investigator: Leonardo Pablo Serra
Australia, New South Wales
Emeritus Research
Botany, New South Wales, Australia, 2019
Contact:Principal Investigator: Paul Bird
The AIM Centre / Hunter Diabetes Centre
Merewether, New South Wales, Australia, 2291
Contact:Contact: 61249632323
Contact:Principal Investigator: Claire Morbey
University of Sydney - Charles Perkins Centre
Sydney, New South Wales, Australia, 2006
Contact:Principal Investigator: Tania Paulette Markovic
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Contact:Contact: 61736468111
Contact:Principal Investigator: Donald So McLeod
Core Research Group
Brisbane, Queensland, Australia, 4064
Contact:Contact: 61738765688
Contact:Principal Investigator: David Martin Colquhoun
CDH Research Institute
Maroochydore, Queensland, Australia, 4558
Contact:Contact: 0754080900
Contact:Principal Investigator: Hansjoerg Seltenreich
Logan Hospital
Meadowbrook, Queensland, Australia, 4131
Contact:Contact: 0449062262
Contact:Principal Investigator: Gaurav Puri
Australia, South Australia
Fusion Clinical Research
Adelaide, South Australia, Australia, 5000
Contact:Principal Investigator: Sepehr Shakib
Nightingale Research
Adelaide, South Australia, Australia, 5000
Contact:Principal Investigator: Andrew Hamilton
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, Australia, 5046
Contact:Contact: 610874258690
Contact:Principal Investigator: Stephen Neil Stranks
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Contact:Contact: 0398954031
Contact:Principal Investigator: Christopher Paul Gilfillan
Emeritus Research
Camberwell, Victoria, Australia, 3124
Contact:Contact: 0395096166
Contact:Principal Investigator: Rebecca Wolf
Barwon Health
Geelong, Victoria, Australia, 3220
Contact:Principal Investigator: Shannon McCarthy
Austin Health - Repatriation Hospital
Heidelberg West, Victoria, Australia, 3081
Contact:Contact: 0394962160
Contact:Principal Investigator: Elif Ekinci
Australia, Western Au
Advara HeartCare Joondalup
Joondalup, Western Au, Australia, 6027
Contact:Contact: 61894006133
Contact:Principal Investigator: Peter Walter Purnell
Canada
Syneos Health
Quebec, Canada, G1P0A2
Contact:Contact: 8193731128
Contact:Principal Investigator: Bruno Francoeur
Canada, British Columbia
BC Diabetes Office
Vancouver, British Columbia, Canada, V5Y 3W2
Contact:Principal Investigator: Thomas G Elliott
Discovery Clinical Services
Victoria, British Columbia, Canada, V8T 5G4
Contact:Contact: 2508892639
Contact:Principal Investigator: Gordon Hoag
Canada, Nova Scotia
Centricity Research - New Minas
New Minas, Nova Scotia, Canada, B4N 3R7
Contact:Contact: 9023653065
Contact:Principal Investigator: Michael Mindrum
Canada, Ontario
Joanne F. Liutkus Medicine Professional Corporation
Cambridge, Ontario, Canada, N3H 4L5
Contact:Contact: 5196248977
Contact:Principal Investigator: Joanne Frances Liutkus
LMC Clinical Research Inc. (Thornhill)
Concord, Ontario, Canada, L4K 4M2
Contact:Contact: 9057638660
Contact:Principal Investigator: Robert Schlosser
Dr. Steven V. Zizzo Medicine Professional Corporation
Hamilton, Ontario, Canada, L8J 0B6
Contact:Principal Investigator: Steven Zizzo
Milestone Research Inc.
London, Ontario, Canada, N5W 6A2
Contact:Contact: 5196594040
Contact:Principal Investigator: Peter Dzongowski
Centricity Research Oshawa
Oshawa, Ontario, Canada, L1J 2K9
Contact:Contact: 9058000630
Contact:Principal Investigator: Rishi Handa
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, Canada, K9J 0B2
Contact:Contact: 7057754278
Contact:Principal Investigator: Michael C. Hartleib
Private Practice - Dr. Pierre Bonin
Sudbury, Ontario, Canada, P3A 1Y8
Contact:Contact: 7055660005
Contact:Principal Investigator: Pierre Bonin
Manna Research Toronto
Toronto, Ontario, Canada, M9W 4L6
Contact:Contact: 4167402895
Contact:Principal Investigator: Noah Vale
Canada, Quebec
Ecogene-21 - Cmas
Chicoutimi, Quebec, Canada, G7H 0S7
Contact:Contact: 4185451252
Contact:Principal Investigator: Daniel Gaudet
Ecogene-21
Chicoutimi, Quebec, Canada, G7H 7K9
Contact:Contact: 4185451252
Contact:Principal Investigator: Daniel Gaudet
Clinique de médecine Urbaine du Quartier Latin
Montreal, Quebec, Canada, H2L 4E9
Contact:Principal Investigator: Elise Sasseville
Centre de Medecine Metabolique de Lanaudiere (CMML)
Terrebonne, Quebec, Canada, J6X 4P7
Contact:Contact: 5149075101
Contact:Principal Investigator: Yves Robitaille
Hungary
Óbudai Egészségügyi Centrum
Budapest, Hungary, 1036
Contact:Contact: 36704508040
Contact:Principal Investigator: Viktor Vass
ClinDiab Kft.
Budapest, Hungary, 1089
Contact:Contact: 36704506822
Contact:Principal Investigator: Krisztina Wudi
TRANTOR'99 Bt. Anyagcsere Centrum
Budapest, Hungary, 1213
Contact:Contact: 36302552083
Contact:Principal Investigator: Ildiko Szatmari
Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház
Debrecen, Hungary, 4031
Contact:Contact: 36306630741
Contact:Principal Investigator: Gizella Petro
Óbudai Egészségügyi Centrum - Zalaegerszeg
Zalaegerszeg, Hungary, 8900
Contact:Contact: 0036302572228
Contact:Principal Investigator: Marianna Baba
Hungary, Békés
Arina Trial Research
Orosháza, Békés, Hungary, 5900
Contact:Contact: 06703695012
Contact:Principal Investigator: Laszlo Nagy
Hungary, Csongrád
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád, Hungary, 6725
Contact:Contact: 36303268449
Contact:Principal Investigator: Tamas Varkonyi
Hungary, Fejér
Regia Med Kft
Szekesfehervar, Fejér, Hungary, 8000
Contact:Contact: 36209148876
Contact:Principal Investigator: Miklos Balsay
Hungary, Nyíregyháza
Medifarma 98 Kft
Nyiregyhaza, Nyíregyháza, Hungary, 4400
Contact:Contact: 06209530430
Contact:Principal Investigator: Zsolt Zilahi
Hungary, Nógrád
Szent Lázár Megyei Kórház
Salgótarján, Nógrád, Hungary, 3100
Contact:Contact: 36303471436
Contact:Principal Investigator: Zsolt Domboróczki
Hungary, Somogy
Óbudai Egészségügyi Centrum - Kaposvár Site
Kaposvár, Somogy, Hungary, 7400
Contact:Contact: 36202332271
Contact:Principal Investigator: Andrea Várkonyi
Hungary, Veszprém
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém, Hungary, 8230
Contact:Contact: 3687481616
Contact:Principal Investigator: Jozsef Pauer
Hungary, Zala
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, Zala, Hungary, 8900
Contact:Contact: 0036309398877
Contact:Principal Investigator: Zoltan Bujtor
Mexico
Investigacion En Salud Y Metabolismo Sc
Chihuahua, Mexico, 31217
Contact:Contact: 526144398618
Contact:Principal Investigator: Luis Alejandro Nevarez
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
Durango, Mexico, 34000
Contact:Contact: 6181894111
Contact:Principal Investigator: José Roberto Lazcano Soto
Centro de Atención e Investigación Cardiovascular del Potosí
San Luis Potosí, Mexico, 78200
Contact:Contact: 524448340596
Contact:Principal Investigator: José Luis Arenas León
FAICIC S. de R.L. de C.V.
Veracruz, Mexico, 91900
Contact:Contact: 522299327808
Contact:Principal Investigator: Alejandro Quintin Barrat Hernandez
Mexico, Baja California
Centro de Investigacion Cardiovascular y Metabólica
Tijuana, Baja California, Mexico, 22500
Contact:Principal Investigator: Pedro Fajardo Campos
Mexico, Distrito Federal
RM Pharma Specialists
Mexico City, Distrito Federal, Mexico, 03100
Contact:Contact: 525565501629
Contact:Principal Investigator: Mariana Zolandi Crespo
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Distrito Federal, Mexico, 11650
Contact:Contact: 525585340943
Contact:Principal Investigator: Melchor Alpizar
Mexico, Hidalgo
Centro Multidisciplinario de Diabetes de Pachuca
Pachuca, Hidalgo, Mexico, 42084
Contact:Contact: 527711072104
Contact:Principal Investigator: Joel Rodriguez-Saldana
Mexico, Jalisco
Unidad de Investigación Clínica y Atención Médica HEPA
Guadalajara, Jalisco, Mexico, 44670
Contact:Contact: 523336422886
Contact:Principal Investigator: Marisol Herrera Marmolejo
Centro de Investigacion Medica de Occidente, S.C.
Zapopan, Jalisco, Mexico, 44260
Contact:Contact: 523312044280
Contact:Principal Investigator: Emilia Susana Pelayo Orozco
Mexico, Nuevo León
IMED Internal Medicine Clin Trials
Monterrey, Nuevo León, Mexico, 64060
Contact:Contact: 528183470078
Contact:Principal Investigator: Jose Angel Garza Ruiz
Clínica García Flores SC
Monterrey, Nuevo León, Mexico, 64610
Contact:Contact: 528183482015
Contact:Principal Investigator: Pedro Alberto Garcia
Eukarya PharmaSite
Monterrey, Nuevo León, Mexico, 64718
Contact:Contact: 528115009790
Contact:Principal Investigator: Guillermo Contreras
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico, 66460
Contact:Contact: 528183483220
Contact:Principal Investigator: Jose Gerardo Gonzalez-Gonzalez
Mexico, Yucatán
Medical Care and Research SA de CV
Merida, Yucatán, Mexico, 97070
Contact:Contact: 9999203879
Contact:Principal Investigator: Carlos Eduardo Medina
EME RED Hospitalaria
Mérida, Yucatán, Mexico, 97000
Contact:Contact: 9992855178
Contact:Principal Investigator: Hugo Antonio Laviada Molina
Poland, Mazowieckie
NBR Polska
Warszawa, Mazowieckie, Poland, 00-710
Contact:Contact: 48514876203
Contact:Principal Investigator: Katarzyna Klodawska
Poland, Małopolskie
RST Rehabilitacja
Bialy Kosciol, Małopolskie, Poland, 32-089
Contact:Principal Investigator: Tomasz Rakowski
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, Małopolskie, Poland, 31-261
Contact:Contact: 48126237122
Contact:Principal Investigator: Joanna Mirocka
Poland, Podlaskie
KLIMED Marek Klimkiewicz
Bialystok, Podlaskie, Poland, 15-704
Contact:Principal Investigator: Irena Glowinska
Poland, Pomorskie
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomorskie, Poland, 80-546
Contact:Contact: 48603790004
Contact:Principal Investigator: Monika Lukaszewicz
Poland, Warmińsko-mazurskie
Ambulatorium Sp. z o.o.
Elbląg, Warmińsko-mazurskie, Poland, 82-300
Contact:Contact: 48608202021
Contact:Principal Investigator: Anna Barbara Bazela-Ostromecka
Poland, Łódzkie
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódzkie, Poland, 90338
Contact:Contact: 607536360
Contact:Principal Investigator: Malgorzata Jozefowska
Poland, Śląskie
Centrum Medyczne Pratia Katowice
Katowice, Śląskie, Poland, 40-081
Contact:Contact: 327462500
Contact:Principal Investigator: Anna Siegel
NZOZ Salvia CM
Katowice, Śląskie, Poland, 40-772
Contact:Contact: 48501353979
Contact:Principal Investigator: Andrzej Madej
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Zabrze, Śląskie, Poland, 41-800
Contact:Contact: 48322712511
Contact:Principal Investigator: Janusz Gumprecht
Puerto Rico
Clinical Research Management Group Inc. - Hospital San Cristobal
Ponce, Puerto Rico, 00716
Contact:Contact: 7872366381
Contact:Principal Investigator: Javier Sosa Faria
Ponce Medical School Foundation Inc.
Ponce, Puerto Rico, 00716
Contact:Contact: 17878402505
Contact:Principal Investigator: Elizabeth A. Barranco-Santana
Latin Clinical Trial Center
San Juan, Puerto Rico, 00909
Contact:Contact: 7879859911
Contact:Principal Investigator: Alex Gonzalez-Bossolo
Slovakia
MediTask
Bratislava, Slovakia, 831 03
Contact:Contact: 421948411118
Contact:Principal Investigator: Jozef Lacka
Slovakia, Banskobystrický Kraj
Nemocnica s poliklinikou Lucenec
Lucenec, Banskobystrický Kraj, Slovakia, 984 01
Contact:Contact: 421474311323
Contact:Principal Investigator: Andrea Cervenakova
Slovakia, Bratislavský Kraj
Metabol KLINIK
Bratislava, Bratislavský Kraj, Slovakia, 811 08
Contact:Contact: 00421903838291
Contact:Principal Investigator: Lubomira Fabryova
MediVet s.r.o.
Malacky, Bratislavský Kraj, Slovakia, 901 01
Contact:Contact: 00421905565208
Contact:Principal Investigator: Eva Pavleova
Slovakia, Košický Kraj
Human Care s.r.o.
Kosice, Košický Kraj, Slovakia, 04001
Contact:Contact: 421905667695
Contact:Principal Investigator: Viera Donicova
Tatratrial s.r.o.
Rožňava, Košický Kraj, Slovakia, 04801
Contact:Contact: 421587329625
Contact:Principal Investigator: Dalibor Sosovec
Areteus s.r.o.
Trebisov, Košický Kraj, Slovakia, 075 01
Contact:Contact: 42176671611
Contact:Principal Investigator: Dasa Skripova
Slovakia, Prešovský Kraj
MEDI-DIA s.r.o.
Sabinov, Prešovský Kraj, Slovakia, 083 01
Contact:Contact: 421907230520
Contact:Principal Investigator: Martina Merciakova
Slovakia, Trenčiansky Kraj
ProDia s.r.o.
Povazska Bystrica, Trenčiansky Kraj, Slovakia, 017 01
Contact:Contact: 421905154448
Contact:Principal Investigator: Vladimir Paulovic
Slovakia, Žilinský Kraj
Diab - Int
Bytca, Žilinský Kraj, Slovakia, 014 01
Contact:Contact: 421907107141
Contact:Principal Investigator: Vladimir Radolec
Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28009
Contact:Contact: 34915866679
Contact:Principal Investigator: Mª OLGA GONZALEZ ALBARRAN
Hospital Universitario Virgen Del Rocio
Sevilla, Spain, 41013
Contact:Contact: 955012000
Contact:Principal Investigator: Virginia Bellido
Spain, A Coruña [La Coruña]
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, A Coruña [La Coruña], Spain, 15405
Contact:Principal Investigator: DIEGO BELLIDO GUERRERO
Spain, Andalucía
Hu Reina Sofia
Cordoba, Andalucía, Spain, 14004
Contact:Principal Investigator: Francisco Javier Delgado Lista
'Hospital Virgen de la Victoria
Malaga, Andalucía, Spain, 29010
Contact:Contact: 951032000
Contact:Principal Investigator: Francisco Jose Tinahones Madueno
Hospital Quiron Infanta Luisa
Sevilla, Andalucía, Spain, 41010
Contact:Contact: 670502836
Contact:Principal Investigator: MARGARITA RIVAS FERNANDEZ
Spain, Balears [Baleares]
Hospital Universitari Son Espases
Palma, Balears [Baleares], Spain, 07120
Contact:Contact: 34871205256
Contact:Principal Investigator: Santiago Tofe Povedano
Spain, Barcelona [Barcelona]
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Contact:Contact: 34697817352
Contact:Principal Investigator: ANDREEA CIUDIN
Spain, Cantabria
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Contact:Contact: 34639659866
Contact:Principal Investigator: Luis Alberto Vazquez
Spain, Cádiz
Hospital Virgen del Camino
Sanlúcar de Barrameda, Cádiz, Spain, 11540
Contact:Contact: 956048000
Contact:Principal Investigator: Manuel Beltran Robles
Hospital Virgen de las Montañas
Villamartin, Cádiz, Spain, 11650
Contact:Contact: 956041000
Contact:Principal Investigator: Enrique Garcia del Rio
Spain, Lleida [Lérida]
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Lleida [Lérida], Spain, 25198
Contact:Contact: 34639143153
Contact:Principal Investigator: Albert Lecube
Spain, Sevilla
Vithas Hospital Sevilla
Seville, Sevilla, Spain, 41950
Contact:Contact: 658011529
Contact:Principal Investigator: Cristobal Jesus Morales Portillo
Spain, Valenciana, Comunitat
Hospital Universitario de La Ribera
Alzira, Valenciana, Comunitat, Spain, 46600
Contact:Contact: 34657845358
Contact:Principal Investigator: carmen fajardo
Open or close this module IPDSharing
Plan to Share IPD: 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.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria:
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/
Open or close this module References
Citations:
Links:
Available IPD/Information:
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