Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT)

February 25, 2022 updated by: Genfit

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

Study Overview

Status

Terminated

Conditions

Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2157

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, 1118
    - Hospital Aleman
  - Buenos Aires, Argentina, 1119
    - Centro de Investigación y Prevención Cardiovascular SA (CIPREC)
  - Buenos Aires, Argentina, 1180
    - Fundacion Sanatorio Güemes
  - Buenos Aires, Argentina, 1181
    - Hospital Italiano de Buenos Aires
  - Buenos Aires, Argentina, 1280
    - Hospital Británico de Buenos Aires
  - Buenos Aires, Argentina, 1430
    - CCBR Clinical Research
  - La Plata, Argentina, 1704
    - Centro De Hepatologia Ciudad de La Plata
  - Pilar, Argentina, 1629
    - Hospital Universitario Austral
  - Ramos Mejía, Argentina, 1704
    - DIM Clinica Privada
  - Rosario, Argentina, 2000
    - Hospital Provincial del Centenario
  - Salta, Argentina, A4400ERH
    - Instituto Médico Alas
- Buenos Aires
  - Caba, Buenos Aires, Argentina, 1180AAX
    - Sanatorio Guemes
  - Caba, Buenos Aires, Argentina, C1430CKE
    - Axismed S.R.L
  - San Nicolas, Buenos Aires, Argentina, 2900
    - Instituto de Investigaciones Clinicas San Nicolas SRL
Australia
- - Bedford Park, Australia, 5042
    - Flinders Medical Centre
  - Box Hill, Australia, 3128
    - Box Hill Hospital
  - Clayton, Australia, 3168
    - Monash Medical Centre Clayton
  - Concord, Australia, 2139
    - Concord Repatriation General Hospital
  - Fitzroy, Australia, 3065
    - St. Vincent's Hospital Melbourne
  - Heidelberg, Australia, 3084
    - Austin Hospital
  - Kingswood, Australia, 2747
    - Nepean Hospital
  - Kogarah, Australia, 2217
    - The St George Hospital
  - Melbourne, Australia, 3004
    - The Alfred Hospital
  - Murdoch, Australia, 6150
    - Fiona Stanley Hospital
  - Nedlands, Australia, 6009
    - Sir Charles Gairdner Hospital (SCGH)
  - Westmead, Australia, 2145
    - Westmead Hospital
Belgium
- - Bruxelles, Belgium, 1070
    - Hopital Erasme
  - Bruxelles, Belgium, 1200
    - Cliniques Universitaires Saint-Luc
  - Bruxelles, Belgium, 1090
    - Universitair Ziekenhuis Brussel
  - Edegem, Belgium, 2650
    - Universitair Ziekenhuis Antwerpen
  - Gent, Belgium, 9000
    - Universitair Ziekenhuis Gent
  - Leuven, Belgium, 3000
    - Universitair Ziekenhuis Leuven
  - Tournai, Belgium, 7500
    - Centre Hospitalier de Wallonie Picardie (CHWAPI)
Canada
- - Calgary, AB, Canada, T2N 4Z6
    - University of Calgary, Cumming School of Medicine
  - Halifax, Canada, B3H 1V7
    - Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
  - Montreal, Canada, H4A 3J1
    - Mc Gill University Health Centre (MUHC)
  - Winnipeg, MB, Canada, R3E 3P4
    - University of Manitoba
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1H2
    - Lair Centre
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre
- Ontario
  - Toronto, Ontario, Canada, M5G 2C4
    - Toronto General Hospital
  - Toronto, Ontario, Canada, M6H 3M1
    - Toronto Liver Centre
  - Toronto, Ontario, Canada, M5G 2C4
    - Toronto Western Hospital
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Monteregie Centre de Recherche
  - Montréal, Quebec, Canada, H4A 3J1
    - The Montreal Chest Institute
Chile
- - La Serena, Chile, 1710209
    - Hospital de La Serena
  - Los Ángeles, Chile, 4430035
    - Alta Salud
  - Santiago, Chile, 8330024
    - Hospital Clinico UC
  - Santiago, Chile, 8380456
    - Hospital Clínico Universidad de Chile
  - Santiago, Chile, 8910108
    - Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment)
  - Vina Del Mar, Chile, 2540488
    - Clínica Reñaca
Colombia
- - Bogotá, Colombia, 04073-5820
    - Fundación Cardio Infantil - Instituto de Cardiología
  - Cali, Colombia, 760032
    - Fundación Valle Del Lili
  - Cali, Colombia, 760042
    - Centro Medico Imbanaco
  - Medellin, Colombia, 50034
    - Hospital Pablo Tobon Uribe
  - Medellin, Colombia, 50010
    - Hospital Universitario San Vicente de Paul Fundación
  - Medellín, Colombia, 050010
    - Fundación Hospitalaria San Vicente de Paul
- Bogota D.C
  - Bogotá, Bogota D.C, Colombia, 110221
    - Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO
Czechia
- - Brno, Czechia, 625 00
    - Fakultni nemocnice Brno
  - Plzen, Czechia, 30100
    - Research Site s.r.o.
  - Plzen, Czechia, 30100
    - Research Site, s.r.o
  - Praha 2, Czechia, 120 00
    - KlinMed s.r.o.
Denmark
- - Aarhus, Denmark, 8000
    - Aarhus University Hospital
Finland
- - Helsinki, Finland, 00029
    - Helsinki University Central Hospital
France
- - Amiens, France, 80054
    - CHU Amiens Picardie
  - Angers, France, 49933
    - CHU Angers
  - Clamart, France, 92140
    - Hôpital Antoine-Béclère
  - Clichy, France, 92110
    - Hopital Beaujon
  - Créteil, France, 94000
    - Hôpital Henri Mondor
  - Limoges, France, 87042
    - CHU Limoges - Hôpital Dupuytren
  - Lyon, France, 69004
    - Hôpital de la Croix-Rousse
  - Marseille, France, 13285
    - Hôpital Saint Joseph
  - Montpellier, France, 34295
    - CHRU Montpellier- Hôpital Saint Eloi
  - Nantes, France, 44093
    - CHU de Nantes - Hôpital Laennec
  - Nice, France, 06202
    - CHU de Nice- Hôpital de l'Archet II
  - Paris, France, 75012
    - Hopital Saint-Antoine
  - Paris, France, 75014
    - Hôpital Cochin
  - Paris, France, 75013
    - Hôpital Pitié-Salpétrière
  - Pessac, France, 33604
    - Hopital Haut-Lévêque
  - Toulouse, France, 31059
    - CHU Toulouse - Hôpital Purpan
  - Vandoeuvre Les Nancy, France, 54511
    - CHU Nancy - Hôpital Brabois
  - Villejuif, France, 94800
    - Hopital Paul Brousse
Germany
- - Aachen, Germany, 52074
    - Universitätsklinikum RWTH Aachen
  - Berlin, Germany, 10969
    - Liver Center
  - Berlin, Germany
    - Gastroenterologie am Bayerischen Platz/ Gastro-Studien
  - Bonn, Germany, 53127
    - Universitätsklinikum Bonn
  - Essen, Germany, 45147
    - Universitätsklinikum Essen
  - Frankfurt, Germany, 60590
    - Universitätsklinikum Frankfurt - Goethe Universität
  - Freiburg, Germany, 79106
    - Universitätsklinikum Freiburg
  - Hamburg, Germany, 20099
    - Asklepios Klinik St. Georg
  - Hamburg, Germany, 20246
    - Universitätsklinikum Hamburg-Eppendorf (UKE)
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover (MHH)
  - Heidelberg, Germany, 69120
    - Universitätsklinikum Heidelberg
  - Köln, Germany, 50937
    - Universitätsklinikum Köln
  - Leipzig, Germany, 04103
    - Universitatsklinikum Leipzig
  - Leipzig, Germany, 04103
    - EUGASTRO GmbH
  - Magdeburg, Germany, 39120
    - Universitätsklinikum Magdeburg
  - Mainz, Germany, 55131
    - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  - Würzburg, Germany, 97080
    - Universitätsklinikum Würzburg
- Northwest
  - Köln, Northwest, Germany, 50937
    - Universitätsklinikum Köln
Italy
- - Bologna, Italy, 40138
    - Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
  - Milano, Italy, 20122
    - Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  - Napoli, Italy, 80131
    - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
  - Palermo, Italy, 90127
    - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  - Palermo, Italy, 90141
    - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  - Roma, Italy, 00133
    - Policlinico Tor Vergata
  - Roma, Italy, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli
  - San Giovanni Rotondo, Italy, 71013
    - Ospedale Casa Sollievo della Sofferenza I.R.C.C.S.
  - Torino, Italy, 10126
    - Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Mexico
- - Acapulco, Mexico, 39670
    - Centro de Investigación Clínica del Pacífico, S.A de C.V.
  - Guadalajara, Mexico
    - Hospital Maria Auxiliadora
  - Mexico City, Mexico, 14050
    - Médica Sur
  - Mexico City, Mexico
    - Consultorio Médico
  - Monterrey, Mexico
    - Accelerium S de RL de C.V.
- DIF
  - Mexico, DIF, Mexico, 6700
    - Hospital Angeles Clinica Londres
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Academisch Medisch Centrum
  - Amsterdam, Netherlands, 1081 HZ
    - Vrije Universiteit Medical Center
  - Maastricht, Netherlands, 6229 HX
    - Maastricht UMC+
  - Nijmegen, Netherlands, 6525 GA
    - Radboud UMC
Portugal
- - Coimbra, Portugal, 3000-075
    - Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
  - Lisboa, Portugal, 1169-050
    - Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
  - Lisboa, Portugal, 1649-035
    - Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
  - Porto, Portugal, 4200-319
    - Centro Hospitalar de São João
  - Porto, Portugal, 4200-319
    - Centro Hospitalar de São João, EPE - Hospital de São João
  - Vila Real, Portugal, 5000-508
    - Centro Hospita de Tras-os-Montes e Alto Douro, EPE
Puerto Rico
- - Rio Grande, Puerto Rico, 00745
    - Caparra Internal Medicine Research Center
  - San Juan, Puerto Rico, 00927
    - Fundacion de Investigacion de Diego
  - San Juan, Puerto Rico, 00909
    - Klinical Investigations Group, LLC
  - San Juan, Puerto Rico, 909
    - Fundación de Investigación
Romania
- - Bucharest, Romania, 022328
    - Institutul Clinic Fundeni
  - Bucharest, Romania, 021105
    - Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
  - Timisoara, Romania, 300002
    - SC Cabinet Particular Policlinic Algomed SRL
  - Timisoara, Romania, 300736
    - Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara
Russian Federation
- - Moscow, Russian Federation, 109240
    - FSBRI "Federal Research Center of nutrition and biotechnology
  - Moscow, Russian Federation, 119991
    - I. M. Sechenov - First Moscow State Medical University
  - Moscow, Russian Federation, 129110
    - M. F. Vladimirsky - Clinical Research Institution of Moscow Region
  - Saint Petersburg, Russian Federation, 194044
    - Military medical academy n. a. S.M. Kirov
  - Saint Petersburg, Russian Federation, 197110
    - St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31
  - St. Petersburg, Russian Federation, 197110
    - City Clinical Hospital No. 31
South Africa
- - Cape Town, South Africa, 7530
    - Tiervlei Trial Centre
  - Cape Town, South Africa, 7800
    - Mediclinic Constantiaberg
  - Port Elizabeth, South Africa, 6001
    - Phoenix Pharma (Pty) Ltd
Spain
- - Barcelona, Spain, 8025
    - Hospital de la Santa Creu i Sant Pau
  - Barcelona, Spain, 8036
    - Hospital Clinic I Provincial
  - Barcelona, Spain, 8035
    - Hospital Universitario Vall d'Hebron
  - Madrid, Spain, 128041
    - Hospital Universitario 12 de Octubre
  - Majadahonda, Spain, 28222
    - Hospital Universitario Puerta de Hierro
  - Málaga, Spain, 29010
    - Hospital Universitario Virgen De La Victoria
  - Pontevedra, Spain, 36071
    - Complexo Hospitalario Universitario de Pontevedra
  - Santander, Spain, 39008
    - Hospital Universitario Marques de Valdecilla
  - Sevilla, Spain, 41014
    - Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)
Sweden
- - Stockholm, Sweden, 14186
    - Karolinska Universitetssjukhuset Huddinge
Switzerland
- - Bern, Switzerland, 3010
    - Inselspital, University Hospital Bern
  - Lausanne, Switzerland, 1011
    - Centre Hospitalier Universitaire Vaudois (Chuv)
  - Saint Gallen, Switzerland, 9007
    - Kantonsspital St. Gallen
  - Zurich, Switzerland, 8091
    - Universitatsspital Zurich
Turkey
- - Ankara, Turkey, 6100
    - Ankara Üniversitesi Tıp Fakültesi
  - Fatih, Turkey, 34093
    - Bezmiâlem Vakıf Üniversitesi
  - Istanbul, Turkey, 34766
    - Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi
  - Izmir, Turkey, 35040
    - Ege Üniversitesi
  - Pendik, Turkey, 34890
    - Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
  - Çapa, Turkey, 34093
    - Istanbul Universitesi Istanbul Tip Fakultesi
United Kingdom
- - Birmingham, United Kingdom, B15 2TT
    - University Hospitals Birmingham NHS Foundation Trust
  - Cambridge, United Kingdom, CB2 0QQ
    - Addenbrooke's Hospital
  - Frimley, United Kingdom, GU16 7UJ
    - Frimley Park Hospital NHS Foundation Trust
  - Hull, United Kingdom, HU3 2JZ
    - Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary
  - London, United Kingdom, SE1 7EH
    - Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
  - London, United Kingdom, E1 1BB
    - Bart Health NHS Trust- Royal London Hospital
  - London, United Kingdom, NW3 2QG
    - The Royal Free London NHS Foundation Trust - The Royal Free Hospital
  - London, United Kingdom, SW170QT
    - St George's University Hospitals NHS Foundation Trust - St George's Hospital
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
  - Nottingham, United Kingdom, NG7 2UH
    - Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre
  - Plymouth, United Kingdom, PL6 8DH
    - Plymouth Hospitals NHS Trust - Derriford Hospital
  - Portsmouth, United Kingdom, PO6 3LY
    - Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - University of Alabama at Birmingham
  - Dothan, Alabama, United States, 36305
    - Digestive Health Specialists of the Southeast
- Arizona
  - Chandler, Arizona, United States, 85224
    - The Institute for Liver Health
  - Glendale, Arizona, United States, 85306
    - The Institute for Liver Health
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Hospital
  - Phoenix, Arizona, United States, 85006
    - Banner University Medical Center Phoenix
  - Phoenix, Arizona, United States, 85013
    - Dignity Health St. Joseph's Hospital
  - Tucson, Arizona, United States, 85712
    - Adobe Clinical Research, LLC
  - Tucson, Arizona, United States, 85711
    - Institute for Liver Health
  - Tucson, Arizona, United States, 85724-0001
    - The University of Arizona College of Medicine Liver Research Institute
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Liver Wellness Center
- California
  - Chula Vista, California, United States, 91910
    - GW Research, Inc.
  - Coronado, California, United States, 92118
    - Southern California Research Center
  - Fresno, California, United States, 93720
    - Fresno Clinical Research Center
  - Fresno, California, United States, 93701-2302
    - University of California, San Francisco, Fresno Community Regional Medical Center
  - Fresno, California, United States, 93721
    - University of California, San Francisco, Fresno Community Regional Medical Center
  - La Jolla, California, United States, 92037
    - University of California - San Diego
  - La Jolla, California, United States, 92037
    - Scripps Clinic Torrey Pines
  - Loma Linda, California, United States, 92354
    - Loma Linda University Medical Center - Transplantation Insitute
  - Long Beach, California, United States, 90822
    - VA Long Beach Healthcare System
  - Los Angeles, California, United States, 90048
    - Cedars Sinai Medical Center
  - Los Angeles, California, United States, 90033
    - Keck Hospital of USC
  - Los Angeles, California, United States, 90036
    - Ruane Clinical Research Group Inc.
  - Los Angeles, California, United States, 90067
    - Gastrointestinal Biosciences Clinical Trials LLC
  - Los Angeles, California, United States, 90073
    - Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center
  - Los Angeles, California, United States, 90073
    - Veterans Affairs Greater Los Angeles Healthcare System
  - Oceanside, California, United States, 92056
    - Alliance Clinical Research
  - Panorama City, California, United States, 91402
    - National Research Institute
  - Poway, California, United States, 92064
    - Alliance Clinical Research
  - Sacramento, California, United States, 95817
    - University of California, Davis Medical Center
  - San Diego, California, United States, 92123
    - Medical Associates Research Group, Inc.
  - San Diego, California, United States, 92161
    - VA San Diego Healthcare System
  - San Diego, California, United States, 92103
    - University of California, San Diego Airway Research and Clinical Trials Center
  - San Francisco, California, United States, 94115
    - Quest Clinical Research
  - San Francisco, California, United States, 94143
    - University of California, San Francisco, Medical Center at Parnassus
  - San Francisco, California, United States, 94115
    - Sutter West Bay Hospitals dba California Pacific Medical Center
  - Ventura, California, United States, 93003
    - Ventura Clinical Trials
- Colorado
  - Englewood, Colorado, United States, 80113
    - South Denver Gastroenterology
- Connecticut
  - New Haven, Connecticut, United States, 65200
    - Yale University School of Medicine, Section of Digestive Diseases
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
  - Washington, District of Columbia, United States, 20007
    - Georgetown University Hospitals
- Florida
  - Boca Raton, Florida, United States, 33434
    - Excel Medical Clinical Trials LLC
  - Doral, Florida, United States, 33166
    - Integrity Clinical Research LLC
  - Gainesville, Florida, United States, 32610
    - University of Florida
  - Inverness, Florida, United States, 34452
    - Nature Coast Clinical Research
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic Hospital
  - Lakewood Ranch, Florida, United States, 34211-4930
    - Florida Digestive Health Specialists, LLP
  - Lakewood Ranch, Florida, United States, 34211
    - Atlantic Gastroenterology Associates, LLC
  - Miami, Florida, United States, 33136
    - University of Miami - Miller School of Medicine
  - Miami, Florida, United States, 33136
    - University of Miami - Schiff Center for Liver Diseases
  - Miami, Florida, United States, 33125-1624
    - Miami VA Healthcare System
  - Wellington, Florida, United States, 33414
    - South Florida Center of Gastroenterology, PA
  - Zephyrhills, Florida, United States, 33542
    - Florida Medical Clinic, PA
- Georgia
  - Athens, Georgia, United States, 30607
    - Summit Clinical Research
  - Atlanta, Georgia, United States, 30308
    - Emory University Hospital Midtown
  - Atlanta, Georgia, United States, 30309
    - Piedmont Atlanta Hospital
  - Atlanta, Georgia, United States, 30312
    - Atlanta Medical Center, Inc.
  - Marietta, Georgia, United States, 30060-8949
    - Gastrointestinal Specialists of Georgia, PC
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - The Queen's Medical Center
- Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago
  - Chicago, Illinois, United States, 60637
    - The University of Chicago Medical Center
  - Chicago, Illinois, United States, 60611
    - Northwestern Memorial Hospital - Arkes Family Pavilion
  - Chicago, Illinois, United States, 60637
    - Rush University Medical Center
  - Maywood, Illinois, United States, 60153
    - Loyola University Chicago
- Kentucky
  - Hazard, Kentucky, United States, 41701
    - Gastroenterology Associates of Hazard
  - Lexington, Kentucky, United States, 40536
    - University Of Kentucky Chandler Medical Center
  - Louisville, Kentucky, United States, 40202
    - University of Louisville Medical / Dental Complex
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Tulane University School of Medicine
  - Shreveport, Louisiana, United States, 71105
    - Louisiana Research Center, LLC
- Maryland
  - Baltimore, Maryland, United States, 21205
    - Johns Hopkins Hospital
  - Bethesda, Maryland, United States, 20889
    - Walter Reed National Military Medical Center
  - Rockville, Maryland, United States, 20850
    - Kaiser Permanente Shady Grove Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center (BIDMC)
  - Worcester, Massachusetts, United States, 06155
    - University of Massachusetts Memorial Medical Center
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Health System, Division of Gastroenterology & Hepatology
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - Gastrointestinal Associates & Endoscopy Center
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Medical Center
- Missouri
  - Kansas City, Missouri, United States, 64131
    - Kansas City Research Institute
  - Kansas City, Missouri, United States, 64128
    - Kansas City VA Medical Center
  - Kansas City, Missouri, United States, 64111
    - St. Luke's Liver Transplant & Specialist
  - Saint Louis, Missouri, United States, 63104
    - Saint Louis University School of Medicine
- New Jersey
  - New Brunswick, New Jersey, United States, 89030
    - Rutgers, Robert Wood Johnson Medical School
  - Newark, New Jersey, United States, 07103
    - Rutgers, New Jersey Medical School
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Southwest Gastroenterology Associates
- New York
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center
  - Buffalo, New York, United States, 14203
    - University at Buffalo, Clinical and Translational Research Center
  - Manhasset, New York, United States, 11030
    - Hofstra Northwell School of Medicine
  - New York, New York, United States, 10029
    - Icahn School of Medicine at Mount Sinai
  - New York, New York, United States, 10016
    - New York University Langone Medical Center
  - New York, New York, United States, 10021
    - Weill Medical College of Cornell University
  - New York, New York, United States, 10016
    - Concorde Medical Group
  - New York, New York, United States, 10032
    - New York-Presbyterian Hospital - Columbia University Medical Center
  - New York, New York, United States, 45267
    - Beth Israel Medical Center
  - Poughkeepsie, New York, United States, 12601
    - Premier Medical Group
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Asheville Gastroenterology Associates
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Health Care System
  - Charlotte, North Carolina, United States, 28204
    - Carolinas Medical Center
  - Durham, North Carolina, United States, 22710
    - Duke Gastroenterology
  - Fayetteville, North Carolina, United States, 28304
    - Cumberland Research Associates, LLC
  - Huntersville, North Carolina, United States, 28078
    - Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
  - Morehead City, North Carolina, United States, 28557
    - Diabetes & Endocrinology Consultants
  - Raleigh, North Carolina, United States, 27612
    - Wake Research Associates
  - Statesville, North Carolina, United States, 28677
    - Piedmont Healthcare
  - Wilmington, North Carolina, United States, 28403
    - Trial Management Associates
- Ohio
  - Cincinnati, Ohio, United States, 45249
    - Consultants for Clinical Research
  - Cincinnati, Ohio, United States, 45249
    - Ohio Gastroenterology & Liver Institute
  - Cincinnati, Ohio, United States, 45267
    - University of Cincinnati Physicians Company , LLC
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Cleveland Medical Center
  - Columbus, Ohio, United States, 43210
    - The Ohio State University Wexner Medical Center
- Oklahoma
  - Tulsa, Oklahoma, United States, 74104-4017
    - Options Health Research, LLC
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Medical Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University
  - Philadelphia, Pennsylvania, United States, 19102
    - Drexel University, College of Medicine
  - Philadelphia, Pennsylvania, United States, 19140
    - Temple University Health System
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC Montefiore
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Charleston, South Carolina, United States, 29401
    - Ralph H. Johnson VA Medical Center
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina (MUSC)
- Tennessee
  - Hermitage, Tennessee, United States, 37076
    - Associates in Gastroenterology, PLC
  - Memphis, Tennessee, United States, 38103
    - Methodist University Hospital
  - Nashville, Tennessee, United States, 37211
    - Quality Medical Research, PLLC
- Texas
  - Arlington, Texas, United States, 76012
    - Texas Clinical Research Institute
  - Dallas, Texas, United States, 75234
    - Liver Center of Texas
  - Dallas, Texas, United States, 75203
    - Methodist Dallas Medical Center
  - Fort Worth, Texas, United States, 76104
    - Baylor All Saints Medical Center - Baylor Research Institute
  - Garland, Texas, United States, 75044
    - DHAT Research Institute
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine
  - Houston, Texas, United States, 77098
    - Gulf Coast Research Group LLC
  - Houston, Texas, United States, 77030
    - Research Specialists of Texas
  - Houston, Texas, United States, 77030
    - Liver Associates of Texas, P.A.
  - Houston, Texas, United States, 77058
    - Centex Studies Inc.
  - Houston, Texas, United States, 78234
    - Brooke Army Medical Center
  - Live Oak, Texas, United States, 78233
    - Gastroenterology Consultants of San Antonio
  - McAllen, Texas, United States, 78504
    - Centex Studies Inc
  - Rollingwood, Texas, United States, 78746
    - Pinnacle Clinical Research, PLLC
  - San Antonio, Texas, United States, 78229
    - Pinnacle Clinical Research, PLLC
  - San Antonio, Texas, United States, 78215
    - The Texas Liver Institute, Inc.
  - Southlake, Texas, United States, 76092-9167
    - Texas Digestive Consultants (TDDC)
  - Victoria, Texas, United States, 77904
    - Victoria Gastroenterology
- Utah
  - Salt Lake City, Utah, United States, 84132
    - University Of Utah School Of Medicine
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Health System
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
  - Falls Church, Virginia, United States, 22042
    - Inova Fairfax Medical Campus - Center for Liver Disease
  - Newport News, Virginia, United States, 23602
    - Bon Secours Liver Institute of Virginia - Newport News
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University
  - Richmond, Virginia, United States, 23249
    - Hunter Holmes McGuire VA Medical Center
  - Richmond, Virginia, United States, 23226
    - Bon Secours Liver Institute of Virginia - Richmond
  - Springfield, Virginia, United States, 22150
    - Kaiser Permanente Springfield Medical Center
- Washington
  - Seattle, Washington, United States, 98104
    - Swedish Organ Transplant and Liver Center
  - Seattle, Washington, United States, 98104-2420
    - Harborview Medical 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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Males or females aged from 18 to 75 years inclusive at first screening visit.
Must provide signed written informed consent and agree to comply with the study protocol.
Females participating in this study must be of nonchildbearing potential or using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment, as described below:
1. Cessation of menses for at least 12 months due to ovarian failure,
2. Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
3. If requested by local IRB regulations and/or National laws, sexual abstinence may be considered adequate (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
4. Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
5. Double contraception with barrier AND highly effective hormonal method of contraception (oral, intravaginal, or transdermal combined estrogen and progestogen hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine hormone-releasing system). The hormonal contraception must be started at least 1 month prior to Randomization.
Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period) with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
NAS score ≥4.
Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy
For participants with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these requirements:
1. No qualitative change 6 months prior to diagnostic liver biopsy up to Randomization (i.e., implementation of a new anti-diabetic therapy) for participants treated with metformin, gliptins, sulfonylureas, sodium/glucose cotransporter (SGLT) 2 inhibitors, glucagon-like peptide (GLP)-1 agonists, or insulin. Dose changes of these medications are allowed in the 6 months prior to diagnostic liver biopsy, except for GLP-1 agonists, which must remain on stable dose in the 6 months prior to diagnostic liver biopsy.
2. No implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks of treatment (Visit 7).

Initiation of any other antidiabetic drugs is allowed after Randomization based on treating physicians' judgment, except for glitazones which are prohibited 6 months prior to diagnostic liver biopsy until the end of treatment.

Exclusion Criteria:

Known heart failure (Grade I to IV of New York Heart Association classification).
History of efficient bariatric surgery within 5 years prior to screening.
Uncontrolled hypertension during the Screening Period despite optimal antihypertensive therapy
Type 1 diabetes participants .
Participants with decompensated diabetes (HbA1c>9%).
Participants with a history of clinically significant acute cardiac event within 6 months prior to screening
Weight loss of more than 5% within 6 months prior to randomization
Compensated and decompensated cirrhosis
Current or recent history (<5 years) of significant alcohol consumption
Pregnant or lactating females or females planning to become pregnant during the study period.
Other well documented causes of chronic liver disease according to standard diagnostic procedures
Participants with previous exposure to Elafibranor
Prohibited concomitant medication
Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.
Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Participants with biological criteria exclusion as per effective protocol

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: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 120 mg Elafibranor Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water	Drug: Elafibranor Other Names: GFT505
Placebo Comparator: Placebo Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis Time Frame: Measurement at 72 weeks	To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.	Measurement at 72 weeks
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes Time Frame: From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)	Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis.	From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage Time Frame: Measurements at 72 weeks	To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.	Measurements at 72 weeks
Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Time Frame: Measurements after 72 weeks of treatment and up to study termination	Hemoglobin A1c (HbA1c) were tested at Week 72. Changes from baseline in HbA1c at Week 72 were evaluated. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.	Measurements after 72 weeks of treatment and up to study termination
Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Time Frame: Measurements after 72 weeks of treatment and up to study termination	High-density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.	Measurements after 72 weeks of treatment and up to study termination
Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Time Frame: Measurements after 72 weeks of treatment and up to study termination	Low-density lipoprotein (LDL) cholesterol was tested at Week 72. Changes from baseline in LDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.	Measurements after 72 weeks of treatment and up to study termination
Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants Time Frame: Measurements after 72 weeks of treatment and up to study termination	Homeostatic model assessment-IR (HOMA-IR) was tested at Week 72. Changes from baseline in HOMA-IR were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.	Measurements after 72 weeks of treatment and up to study termination
Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Time Frame: Measurements after 72 weeks of treatment and up to study termination	Non-high density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in non-HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.	Measurements after 72 weeks of treatment and up to study termination
Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo Time Frame: Measurements after 72 weeks of treatment and up to study termination	Triglycerides was tested at Week 72. Changes from baseline in triglycerides were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.	Measurements after 72 weeks of treatment and up to study termination

Collaborators and Investigators

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

Sponsor

Genfit

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

March 1, 2016

Primary Completion (Actual)

October 28, 2020

Study Completion (Actual)

October 28, 2020

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

GFT505-315-1
2015-005385-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Clinical Trials on Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Clinical Trials on Placebo

Search Similar Trials

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