AzTrials
AzTrials

Nonalcoholic Steatohepatitis (NASH) With FibrosisPhase 3RESOLVE-ITNCT02704403

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

A Phase 3 study testing Elafibranor in people with Nonalcoholic Steatohepatitis (NASH) With Fibrosis, run by Genfit at 326 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Elafibranor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,157 participants
Where
326 sitesin 25 countries
Study dates
Mar 2016to 28 Oct 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Cessation of menses for at least 12 months due to ovarian failure,
  • Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
  • 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)
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  • Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
  • 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:
  • 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.
  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

326 sites in 25 countries.

326 sites in 25 countries

United States153 sites

  • Southwest Gastroenterology Associates

    Albuquerque, New Mexico, 87109

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates

    Asheville, North Carolina, 28801

  • Summit Clinical Research

    Athens, Georgia, 30607

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • Atlanta Medical Center, Inc.

    Atlanta, Georgia, 30312

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida, 33434

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215

  • University at Buffalo, Clinical and Translational Research Center

    Buffalo, New York, 14203

  • The Institute for Liver Health

    Chandler, Arizona, 85224

  • UNC Health Care System

    Chapel Hill, North Carolina, 27599

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital - Arkes Family Pavilion

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60637

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Chicago

    Chicago, Illinois, 60637

  • GW Research, Inc.

    Chula Vista, California, 91910

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45249

  • Ohio Gastroenterology & Liver Institute

    Cincinnati, Ohio, 45249

  • University of Cincinnati Physicians Company , LLC

    Cincinnati, Ohio, 45267

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Southern California Research Center

    Coronado, California, 92118

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Liver Center of Texas

    Dallas, Texas, 75234

  • Henry Ford Health System, Division of Gastroenterology & Hepatology

    Detroit, Michigan, 48202

  • Integrity Clinical Research LLC

    Doral, Florida, 33166

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Duke Gastroenterology

    Durham, North Carolina, 22710

  • South Denver Gastroenterology

    Englewood, Colorado, 80113

  • Inova Fairfax Medical Campus - Center for Liver Disease

    Falls Church, Virginia, 22042

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • Gastrointestinal Associates & Endoscopy Center

    Flowood, Mississippi, 39232

  • Baylor All Saints Medical Center - Baylor Research Institute

    Fort Worth, Texas, 76104

  • University of California, San Francisco, Fresno Community Regional Medical Center

    Fresno, California, 93701-2302

  • Fresno Clinical Research Center

    Fresno, California, 93720

  • University of California, San Francisco, Fresno Community Regional Medical Center

    Fresno, California, 93721

  • University of Florida

    Gainesville, Florida, 32610

  • DHAT Research Institute

    Garland, Texas, 75044

  • The Institute for Liver Health

    Glendale, Arizona, 85306

  • Gastroenterology Associates of Hazard

    Hazard, Kentucky, 41701

  • Associates in Gastroenterology, PLC

    Hermitage, Tennessee, 37076

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Liver Associates of Texas, P.A.

    Houston, Texas, 77030

  • Research Specialists of Texas

    Houston, Texas, 77030

  • Centex Studies Inc.

    Houston, Texas, 77058

  • Gulf Coast Research Group LLC

    Houston, Texas, 77098

  • Brooke Army Medical Center

    Houston, Texas, 78234

  • Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health

    Huntersville, North Carolina, 28078

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic Hospital

    Jacksonville, Florida, 32224

  • St. Luke's Liver Transplant & Specialist

    Kansas City, Missouri, 64111

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Scripps Clinic Torrey Pines

    La Jolla, California, 92037

  • University of California - San Diego

    La Jolla, California, 92037

  • Florida Digestive Health Specialists, LLP

    Lakewood Rch, Florida, 34211-4930

  • Atlantic Gastroenterology Associates, LLC

    Lakewood Rch, Florida, 34211

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • Liver Wellness Center

    Little Rock, Arkansas, 72205

  • Gastroenterology Consultants of San Antonio

    Live Oak, Texas, 78233

  • Loma Linda University Medical Center - Transplantation Insitute

    Loma Linda, California, 92354

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • Ruane Clinical Research Group Inc.

    Los Angeles, California, 90036

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Gastrointestinal Biosciences Clinical Trials LLC

    Los Angeles, California, 90067

  • Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center

    Los Angeles, California, 90073

  • Veterans Affairs Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • University of Louisville Medical / Dental Complex

    Louisville, Kentucky, 40202

  • Hofstra Northwell School of Medicine

    Manhasset, New York, 11030

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060-8949

  • Loyola University Chicago

    Maywood, Illinois, 60153

  • Centex Studies Inc

    McAllen, Texas, 78504

  • Methodist University Hospital

    Memphis, Tennessee, 38103

  • Miami VA Healthcare System

    Miami, Florida, 33125-1624

  • University of Miami - Miller School of Medicine

    Miami, Florida, 33136

  • University of Miami - Schiff Center for Liver Diseases

    Miami, Florida, 33136

  • Diabetes & Endocrinology Consultants

    Morehead City, North Carolina, 28557

  • Quality Medical Research, PLLC

    Nashville, Tennessee, 37211

  • Rutgers, Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 89030

  • Yale University School of Medicine, Section of Digestive Diseases

    New Haven, Connecticut, 65200

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Concorde Medical Group

    New York, New York, 10016

  • New York University Langone Medical Center

    New York, New York, 10016

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • New York-Presbyterian Hospital - Columbia University Medical Center

    New York, New York, 10032

  • Beth Israel Medical Center

    New York, New York, 45267

  • Rutgers, New Jersey Medical School

    Newark, New Jersey, 07103

  • Bon Secours Liver Institute of Virginia - Newport News

    Newport News, Virginia, 23602

  • Alliance Clinical Research

    Oceanside, California, 92056

  • National Research Institute

    Panorama City, California, 91402

  • Drexel University, College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University Health System

    Philadelphia, Pennsylvania, 19140

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • Dignity Health St. Joseph's Hospital

    Phoenix, Arizona, 85013

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • UPMC Montefiore

    Pittsburgh, Pennsylvania, 15213

  • Premier Medical Group

    Poughkeepsie, New York, 12601

  • Alliance Clinical Research

    Poway, California, 92064

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Bon Secours Liver Institute of Virginia - Richmond

    Richmond, Virginia, 23226

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Kaiser Permanente Shady Grove Medical Center

    Rockville, Maryland, 20850

  • Pinnacle Clinical Research, PLLC

    Rollingwood, Texas, 78746

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84132

  • The Texas Liver Institute, Inc.

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research, PLLC

    San Antonio, Texas, 78229

  • University of California, San Diego Airway Research and Clinical Trials Center

    San Diego, California, 92103

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • VA San Diego HealthCare System

    San Diego, California, 92161

  • Quest Clinical Research

    San Francisco, California, 94115

  • Sutter West Bay Hospitals dba California Pacific Medical Center

    San Francisco, California, 94115

  • University of California, San Francisco, Medical Center at Parnassus

    San Francisco, California, 94143

  • Harborview Medical Center

    Seattle, Washington, 98104-2420

  • Swedish Organ Transplant and Liver Center

    Seattle, Washington, 98104

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Texas Digestive Consultants (TDDC)

    Southlake, Texas, 76092-9167

  • Kaiser Permanente Springfield Medical Center

    Springfield, Virginia, 22150

  • Saint Louis University School of Medicine

    St Louis, Missouri, 63104

  • Piedmont Healthcare

    Statesville, North Carolina, 28677

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Institute for Liver Health

    Tucson, Arizona, 85711

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712

  • The University of Arizona College of Medicine Liver Research Institute

    Tucson, Arizona, 85724-0001

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104-4017

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Victoria Gastroenterology

    Victoria, Texas, 77904

  • Georgetown University Hospitals

    Washington D.C., District of Columbia, 20007

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • South Florida Center of Gastroenterology, PA

    Wellington, Florida, 33414

  • Trial Management Associates

    Wilmington, North Carolina, 28403

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 06155

  • Florida Medical Clinic, PA

    Zephyrhills, Florida, 33542

Other trials in United States

France18 sites

  • CHU Amiens Picardie

    Amiens, 80054

  • CHU Angers

    Angers, 49933

  • Hôpital Antoine-Béclère

    Clamart, 92140

  • Hôpital Beaujon

    Clichy, 92110

  • Hôpital Henri Mondor

    Créteil, 94000

  • CHU Limoges - Hôpital Dupuytren

    Limoges, 87042

  • Hôpital de la Croix-Rousse

    Lyon, 69004

  • Hôpital Saint Joseph

    Marseille, 13285

  • CHRU Montpellier- Hôpital Saint Eloi

    Montpellier, 34295

  • CHU de Nantes - Hôpital Laennec

    Nantes, 44093

  • CHU de Nice- Hôpital de l'Archet II

    Nice, 06202

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hopital Pitie-Salpetriere

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Haut-Lévêque

    Pessac, 33604

  • CHU Toulouse - Hôpital Purpan

    Toulouse, 31059

  • CHU Nancy - Hôpital Brabois

    Vandœuvre-lès-Nancy, 54511

  • Hôpital Paul Brousse

    Villejuif, 94800

Other trials in France

Germany18 sites

  • Universitätsklinikum RWTH Aachen

    Aachen, 52074

  • Liver Center

    Berlin, 10969

  • Gastroenterologie am Bayerischen Platz/ Gastro-Studien

    Berlin

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Köln

    Cologne, Northwest, 50937

  • Universitätsklinikum Köln

    Cologne, 50937

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitätsklinikum Frankfurt - Goethe Universität

    Frankfurt, 60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    Hamburg, 20246

  • Medizinische Hochschule Hannover (MHH)

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • EUGASTRO GmbH

    Leipzig, 04103

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Argentina14 sites

  • Hospital Alemán

    Buenos Aires, 1118

  • Centro de Investigación y Prevención Cardiovascular SA (CIPREC)

    Buenos Aires, 1119

  • Fundación Sanatorio Güemes

    Buenos Aires, 1180

  • Hospital Italiano de Buenos Aires

    Buenos Aires, 1181

  • Hospital Británico de Buenos Aires

    Buenos Aires, 1280

  • CCBR Clinical Research

    Buenos Aires, 1430

  • Sanatorio Güemes

    Caba, Buenos Aires, 1180AAX

  • Axismed S.R.L

    CABA, Buenos Aires, C1430CKE

  • Centro De Hepatologia Ciudad de La Plata

    La Plata, 1704

  • Hospital Universitario Austral

    Pilar, 1629

  • Dim Clinica Privada

    Ramos Mejía, 1704

  • Hospital Provincial del Centenario

    Rosario, 2000

  • Instituto Medico Alas

    Salta, A4400ERH

  • Instituto de Investigaciones Clinicas San Nicolas SRL

    San Nicolás de los Arroyos, Buenos Aires, 2900

Other trials in Argentina

Australia12 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Box Hill Hospital

    Box Hill, 3128

  • Monash Medical Centre Clayton

    Clayton, 3168

  • Concord Repatriation General Hospital

    Concord, 2139

  • St. Vincent's Hospital Melbourne

    Fitzroy, 3065

  • Austin Hospital

    Heidelberg, 3084

  • Nepean Hospital

    Kingswood, 2747

  • The St George Hospital

    Kogarah, 2217

  • The Alfred Hospital

    Melbourne, 3004

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Sir Charles Gairdner Hospital (SCGH)

    Nedlands, 6009

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

United Kingdom12 sites

  • University Hospitals Birmingham NHS foundation Trust

    Birmingham, B15 2TT

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Frimley Park Hospital NHS Foundation Trust

    Frimley, GU16 7UJ

  • Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary

    Hull, HU3 2JZ

  • Bart Health NHS Trust- Royal London Hospital

    London, E1 1BB

  • The Royal Free London NHS Foundation Trust - The Royal Free Hospital

    London, NW3 2QG

  • Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

    London, SE1 7EH

  • St George's University Hospitals NHS Foundation Trust - St George's Hospital

    London, SW170QT

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre

    Nottingham, NG7 2UH

  • Plymouth Hospitals NHS Trust - Derriford Hospital

    Plymouth, PL6 8DH

  • Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Canada11 sites

  • University of Calgary, Cumming School of Medicine

    Calgary, AB, T2N 4Z6

  • Monteregie Centre de Recherche

    Greenfield Park, Quebec, J4V 2H1

  • Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

    Halifax, B3H 1V7

  • The Montreal Chest Institute

    Montreal, Quebec, H4A 3J1

  • Mc Gill University Health Centre (MUHC)

    Montreal, H4A 3J1

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Toronto Western Hospital

    Toronto, Ontario, M5G 2C4

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • LAIR Centre

    Vancouver, British Columbia, V5Z 1H2

  • Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

  • University of Manitoba

    Winnipeg, MB, R3E 3P4

Other trials in Canada

Italy9 sites

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples, 80131

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90141

  • Policlinico Tor Vergata

    Roma, 00133

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Ospedale Casa Sollievo della Sofferenza I.R.C.C.S.

    San Giovanni Rotondo, 71013

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

    Torino, 10126

Other trials in Italy

Spain9 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035

  • Hospital Clinic i Provincial

    Barcelona, 8036

  • Hospital Universitario 12 de Octubre

    Madrid, 128041

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28222

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Complexo Hospitalario Universitario de Pontevedra

    Pontevedra, 36071

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)

    Seville, 41014

Other trials in Spain

Belgium7 sites

  • Hôpital Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

  • Centre Hospitalier de Wallonie Picardie (CHWAPI)

    Tournai, 7500

Other trials in Belgium

Colombia7 sites

  • Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO

    Bogotá, Bogota D.C., 110221

  • Fundación Cardio Infantil - Instituto de Cardiología

    Bogotá, 04073-5820

  • Fundación Valle del Lili

    Cali, 760032

  • Centro Medico Imbanaco

    Cali, 760042

  • Fundacion Hospitalaria San Vicente de Paul

    Medellín, 050010

  • Hospital Universitario San Vicente de Paul Fundación

    Medellín, 50010

  • Hospital Pablo Tobon Uribe

    Medellín, 50034

Other trials in Colombia

Chile6 sites

  • Hospital de La Serena

    La Serena, 1710209

  • Alta Salud

    Los Ángeles, 4430035

  • Hospital Clínico UC

    Santiago, 8330024

  • Hospital Clínico Universidad de Chile

    Santiago, 8380456

  • Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment)

    Santiago, 8910108

  • Clínica Reñaca

    Viña del Mar, 2540488

Other trials in Chile

Mexico6 sites

  • Centro de Investigación Clínica del Pacífico, S.A de C.V.

    Acapulco, 39670

  • Hospital Maria Auxiliadora

    Guadalajara

  • Hospital Angeles Clinica Londres

    México, DIF, 6700

  • Médica Sur

    Mexico City, 14050

  • Consultorio Medico

    Mexico City

  • Accelerium S de RL de C.V.

    Monterrey

Other trials in Mexico

Portugal6 sites

  • Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075

  • Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos

    Lisbon, 1169-050

  • Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

    Lisbon, 1649-035

  • Centro Hospitalar de São João, EPE - Hospital de São João

    Porto, 4200-319

  • Centro Hospitalar de São João

    Porto, 4200-319

  • Centro Hospita de Tras-os-Montes e Alto Douro, EPE

    Vila Real, 5000-508

Other trials in Portugal

Russia6 sites

  • FSBRI "Federal Research Center of nutrition and biotechnology

    Moscow, 109240

  • I. M. Sechenov - First Moscow State Medical University

    Moscow, 119991

  • M. F. Vladimirsky - Clinical Research Institution of Moscow Region

    Moscow, 129110

  • Military medical academy n. a. S.M. Kirov

    Saint Petersburg, 194044

  • City Clinical Hospital No. 31

    Saint Petersburg, 197110

  • St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31

    Saint Petersburg, 197110

Other trials in Russia

Turkey (Türkiye)6 sites

  • Ankara Üniversitesi Tıp Fakültesi

    Ankara, 6100

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Çapa, 34093

  • Bezmiâlem Vakıf Üniversitesi

    Fatih, 34093

  • Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi

    Istanbul, 34766

  • Ege Üniversitesi

    Izmir, 35040

  • Marmara Üniversitesi Eğitim ve Araştırma Hastanesi

    Pendik, 34890

Other trials in Turkey (Türkiye)

Czechia4 sites

  • Fakultní Nemocnice Brno

    Brno, 625 00

  • Research Site S.R.O.

    Pilsen, 30100

  • Research Site, s.r.o

    Pilsen, 30100

  • KlinMed s.r.o.

    Prague, 120 00

Other trials in Czechia

Netherlands4 sites

  • Vrije Universiteit Medical Center

    Amsterdam, 1081 HZ

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Maastricht UMC+

    Maastricht, 6229 HX

  • Radboud UMC

    Nijmegen, 6525 GA

Other trials in Netherlands

Puerto Rico4 sites

  • Caparra Internal Medicine Research Center

    Rio Grande, 00745

  • Klinical Investigations Group, LLC

    San Juan, 00909

  • Fundacion de Investigacion de Diego

    San Juan, 00927

  • Fundación de Investigación

    San Juan, 909

Other trials in Puerto Rico

Romania4 sites

  • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

    Bucharest, 021105

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • SC Cabinet Particular Policlinic Algomed SRL

    Timișoara, 300002

  • Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara

    Timișoara, 300736

Other trials in Romania

Switzerland4 sites

  • INSELSPITAL, University Hospital Bern

    Bern, 3010

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

South Africa3 sites

  • Tiervlei Trial Centre

    Cape Town, 7530

  • Mediclinic Constantiaberg

    Cape Town, 7800

  • Phoenix Pharma (Pty) Ltd

    Port Elizabeth, 6001

Other trials in South Africa

Denmark1 site

  • Aarhus University Hospital

    Aarhus, 8000

Other trials in Denmark

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, 00029

Other trials in Finland

Sweden1 site

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 14186

Other trials in Sweden

About this study

Official title: 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.

Being tested
Elafibranor, Placebo
Keywords
Elafibranor, NASH, Nonalcoholic steatohepatitis, Fatty liver disease, Fibrosis
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fibrosis

What participants receive

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

  • ElafibranorDrug

    Also called GFT505

  • PlaceboDrug

Study groups in NCT02704403
Study groupRoleWhat they receive
120 mg ElafibranorExperimentalCoated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water
Receives: Drug: Elafibranor
PlaceboPlacebo comparatorCoated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Receives: Drug: Placebo

What is being measured

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

  1. Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis

    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.

    Measured: Measurement at 72 weeks

  2. Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes

    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.

    Measured: 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 outcomes (7)

  1. Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage

    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.

    Measured: Measurements at 72 weeks

  2. Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

    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.

    Measured: Measurements after 72 weeks of treatment and up to study termination

  3. Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

    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.

    Measured: Measurements after 72 weeks of treatment and up to study termination

  4. Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

    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.

    Measured: Measurements after 72 weeks of treatment and up to study termination

  5. 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

    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.

    Measured: Measurements after 72 weeks of treatment and up to study termination

  6. Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

    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.

    Measured: Measurements after 72 weeks of treatment and up to study termination

  7. Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

    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.

    Measured: Measurements after 72 weeks of treatment and up to study termination

Timeline

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

  1. First posted10 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion28 Oct 2020
  4. Study completion28 Oct 2020

Why it stopped: Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02704403
Sponsor's protocol ID
GFT505-315-1
Other IDs
2015-005385-38, 2015
Acronym
RESOLVE-IT
Status last verified
Feb 2022
First submitted
16 Feb 2016
Last updated
23 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elafibranor in people with Nonalcoholic Steatohepatitis (NASH) With Fibrosis, run by Genfit at 326 sites in 25 countries.

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

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 326 sites in United States, France, Germany, Argentina, Australia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis (time frame: Measurement at 72 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02704403.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.

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