AzTrials
AzTrials

Non Alcoholic Steatohepatitis (NASH)Phase 3REGENERATENCT02548351

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

A Phase 3 study testing Obeticholic Acid in people with Non Alcoholic Steatohepatitis (NASH), run by Intercept Pharmaceuticals at 346 sites in 21 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 Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Non Alcoholic Steatohepatitis (NASH)
What is being tested?
Obeticholic Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,477 participants
Where
346 sitesin 21 countries
Study dates
22 Sep 2015to 15 Sep 2023
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
  • Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or
  • Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the following risk factors:
  • Obesity (BMI ≥30 kg/m2)
  • Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria
  • ALT >1.5× upper limit of normal (ULN).
  • For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
  • Stable body weight.

Who cannot join

  • Model for End-stage Liver Disease (MELD) score >12
  • ALT ≥10× ULN
  • HbA1c >9.5%
  • Total bilirubin >1.5 mg/dL
  • Evidence of other known forms of known chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
  • History of liver transplant, or current placement on a liver transplant list
Show all 13Show fewer
  • Current or history of significant alcohol consumption
  • Prior or planned ileal resection, or prior or planned bariatric surgery
  • Histological presence of cirrhosis
  • History of biliary diversion
  • Known positivity for human immunodeficiency virus infection.
  • Acute cholecystitis or acute biliary obstruction.
  • BMI >45 kg/m2

Trial locations and contacts

346 sites in 21 countries.

346 sites in 21 countries

United States175 sites

  • AccumetRx Clinical research / UGNM

    Albuquerque, New Mexico, 87109

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates, PA

    Asheville, North Carolina, 28801

  • Summit Clinical Research, LLC

    Athens, Georgia, 30607

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • The Emory Clinic (TEC)

    Atlanta, Georgia, 30322

  • University of Colorado Denver and Hospital

    Aurora, Colorado, 80045

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The Medical Center of Bowling Green

    Bowling Green, Kentucky, 42101

  • University at Buffalo, Clinical and Translational Research Center

    Buffalo, New York, 14203

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • The University of Vermont Medical Center - Smith 2

    Burlington, Vermont, 05401

  • Institute for Liver Health DBA Arizona Liver Health

    Chandler, Arizona, 85224

  • University of North Carolina at Chapel Hill, School of Medicine

    Chapel Hill, North Carolina, 27599-7584

  • Center for Liver Disease

    Charlotte, North Carolina, 28204

  • Charlotte Gastroenterology & Hepatology

    Charlotte, North Carolina, 28207

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • WR-Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • Northwestern University, Feinberg School of Medicine

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • GW Research Inc.

    Chula Vista, California, 91910

  • Precision Research Institute

    Chula Vista, California, 91910

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45249

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0595

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43203

  • Southern California Research Center

    Coronado, California, 92118

  • Citrus Valley Gastroenterology

    Covina, California, 91722

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Liver Center of Texas

    Dallas, Texas, 75234

  • Texas Digestive Disease Consultants

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Integrity Clinical Research, LLC

    Doral, Florida, 33166

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Doylestown Health Gastroenterology

    Doylestown, Pennsylvania, 18901

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • TriWest Research Associates, LLC

    El Cajon, California, 92020

  • MedResearch, Inc.

    El Paso, Texas, 79935

  • South Denver Gastroenterology, PC

    Englewood, Colorado, 80113

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • Hillmont GI, pc

    Flourtown, Pennsylvania, 19031

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Baylor Scott & White All Saints Medical Center

    Fort Worth, Texas, 76104

  • Texas Digestive Disease Consultants

    Fort Worth, Texas, 76104

  • UCSF Fresno, Clinical Research Center

    Fresno, California, 93701

  • Fresno Clinical Research Center

    Fresno, California, 93720

  • UF Hepatology Research at CTRB

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

  • Arizona Liver Health - Glendale

    Glendale, Arizona, 85306

  • Prisma Health- Upstate Gastroenterology and Liver Center

    Greenville, South Carolina, 29605

  • Associates in Gastroenterology, PLC

    Hermitage, Tennessee, 37076

  • The Pennsylvania State University and The Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • The Queen's Medical Center - Liver Center

    Honolulu, Hawaii, 96813

  • Baylor College of Medicine Ben Taub General Hospital

    Houston, Texas, 77030

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Liver Associates of Texas, P.A.

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition

    Houston, Texas, 77030

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Carolinas Center for Liver Disease/Carolinas HeatlhCare System

    Huntersville, North Carolina, 28078

  • Grand Teton Research Group

    Idaho Falls, Idaho, 83404

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

  • Indianapolis Gastroenterology & Hepatology

    Indianapolis, Indiana, 46237

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Southern Therapy and Advanced Research, LLC

    Jackson, Mississippi, 39216

  • Clinical Research Solutions

    Jackson, Tennessee, 38305

  • UF Health Jacksonville-Gastroenterology Emerson

    Jacksonville, Florida, 32207

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • East Tennesse Research Institute

    Johnson City, Tennessee, 37604

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Scripps Clinic

    La Jolla, California, 92037

  • University of California, San Diego

    La Jolla, California, 92037

  • Florida Digestive Health Specialist Research Institute

    Lakewood Rch, Florida, 34211

  • Hillmont G.I. - Lansdale Office

    Lansdale, Pennsylvania, 19446

  • Sunrise Medical Research, Inc.

    Lauderdale Lakes, Florida, 33319

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • Liver Wellness Center

    Little Rock, Arkansas, 72205

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • National Research Institute, Wilshire

    Los Angeles, California, 90057

  • Gastrointestinal Biosciences

    Los Angeles, California, 90067

  • Veteran Affairs Great Los Angeles Healthcare System

    Los Angeles, California, 90073

  • University of Louisville Medical, Clinical Trials Unit

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital & Clinics

    Madison, Wisconsin, 53705

  • Meridien Research

    Maitland, Florida, 32751

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Amici Clinical Research

    Martinsville, New Jersey, 08836

  • Amici GI - LLC

    Martinsville, New Jersey, 08836

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Centex Studies, Inc.

    McAllen, Texas, 78504

  • Methodist Healthcare, University Hospital

    Memphis, Tennessee, 38104

  • Bruce W. Carter Miami VA Medical Center

    Miami, Florida, 33125

  • Schiff Center for Liver Diseases

    Miami, Florida, 33136

  • ProLive Medical Research

    Miami, Florida, 33175

  • Janus Clinical Research, Inc.

    Miami, Florida, 33186

  • Minnesota Gastroenterology

    Minneapolis, Minnesota, 55413

  • Nashville Gastrointestinal Specialists

    Nashville, Tennessee, 37205

  • Quality Medical Research, PLLC

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Mount Sinai Beth Israel

    New York, New York, 10003

  • Concorde Medical Group PLLC

    New York, New York, 10016

  • New York University (NYU) Langone Medical Center

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Rutgers University New Jersey Medical School

    Newark, New Jersey, 07103

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • INTEGRIS Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • CHI Health Alegent Creighton Clinic Gastroenterology

    Omaha, Nebraska, 68124

  • Florida Hospital Transplant Institute

    Orlando, Florida, 32804

  • Stanford University

    Palo Alto, California, 94304

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Drexel University

    Philadelphia, Pennsylvania, 19102

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Rapid City Medical Center

    Rapid City, South Dakota, 57701

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226

  • McGuire DVAMC GI

    Richmond, Virginia, 23249

  • Virginia Commonwealth University Clinical Research Services Unit (CRSU)

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215

  • Gastroenterology Consultants of San Antonio

    San Antonio, Texas, 78229

  • eStudy Site

    San Diego, California, 92120

  • Medical Associates Research Group

    San Diego, California, 92123

  • Kaiser Permanente

    San Diego, California, 92154

  • California Pacific Medical Center (CPMC)

    San Francisco, California, 94109

  • UCSF/ San Francisco General Hospital

    San Francisco, California, 94110

  • Quest Clinical Research

    San Francisco, California, 94115

  • University of California, San Francisco

    San Francisco, California, 94143

  • Silicon Valley Research Institute

    San Jose, California, 95128

  • Texas Digestive Disease Consultants - San Marcos

    San Marcos, Texas, 78666

  • Virginia Mason - Seattle Medical Center

    Seattle, Washington, 98101

  • Swedish Organ Transplant and Liver Center

    Seattle, Washington, 98104

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Saint Louis University Gastroenterology & Hepatology

    St Louis, Missouri, 63104

  • Washington University School of Medicine - Gastroenterology

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Arizona Liver Clinic - Tucson

    Tucson, Arizona, 85711

  • South Florida Center of Gastroenterology, P.A.

    Wellington, Florida, 33414

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado, 80033

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

  • Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research

    Wyoming, Michigan, 49519

  • Huron Gastroenterology Associates/Center for Digestive Care

    Ypsilanti, Michigan, 48197

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

United Kingdom22 sites

  • Institute of Biomedical Research

    Birmingham, B15 2TT

  • Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • University Hospital Bristol NHS Foundation Trust

    Bristol, BS2 8HW

  • Cambridge University Hospital

    Cambridge, CB2 0QQ

  • University Hospitals Coventry & Warwickshire

    Coventry, CV2 2DX

  • Glasgow Royal Infirmary, NHS Greater

    Glasgow, G4 0SF

  • Royal Surrey NHS Foundation Trust

    Guildford, Surrey, GU27XX

  • John Radcliffe Hospital

    Headington, Oxford, OX3 9DU

  • Gastroenterology Department Hull Royal Infirmary

    Hull, HU3 2JZ

  • University Hospital Aintree

    Liverpool, L9 7AL

  • Royal London Hospital

    London, E1 1FR

  • Institute for Liver and Digestive Health

    London, NW3 2QG

  • Guy's and St. Thomas NHS Foundation Trust

    London, SE1 9RT

  • St. Mary's Hospital

    London, W2 1NY

  • Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary

    Manchester, M13 9WL

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE7 7DN

  • Norfolk and Norwich University Hospitals

    Norwich, Norfolk, NR4 7UY

  • Nottingham Digestive Diseases and Biomedical Research Unit

    Nottingham, NG7 2UH

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Queen Alexandra Hospital

    Portsmouth, Hampshire, PO6 3LY

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

France19 sites

  • CHU Amiens Picardie

    Amiens, 80054

  • CHU Angers-Service d'Hepato-Gastroenterologie

    Angers, 49933

  • Centre hospitalier Pierre Oudot

    Bourgoin, 38300

  • CHU Beaujon-Service d'Hépatologie

    Clichy, 92110

  • Hôpital Henri Mondor - Service d'hépatologie

    Créteil, 94000

  • CHU Grenoble

    Grenoble, 38700

  • CHRU Hôpital Claude Huriez

    Lille, 59037

  • Hôpital de la Croix Rousse

    Lyon, 69004

  • Hôpital Saint Joseph

    Marseille, 13008

  • Hôpital de l'Archet II-CHU Nice

    Nice, 6202

  • Service d'Hepato-Gastroenterologie CHR Orleans - La Source

    Orléans, 45100

  • Hospital Saint Antoine Department of Hepatology

    Paris, 75012

  • Hôpital de la Pitié Salpétrère

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • Hopital Haut-Lévêque-Hépatogastroentérologie-Bât USN

    Pessac, 33604

  • CHU de Rouen

    Rouen, 76031

  • CHU Toulouse - Hopital de Purpan

    Toulouse, 31059

  • CHU de Nancy - Hôpital de Brabois adultes

    Vandœuvre-lès-Nancy, 54500

  • Hopital Paul Brousse

    Villejuif, 94804

Other trials in France

Spain19 sites

  • Hospital Universitario Fundación Alcorcon

    Alcorcón, 28922

  • Hospital General y Universitario de Alicante

    Alicante, 03010

  • Hospital del Mar Gastroenterology Department

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic(o) de Barcelona

    Barcelona, 08036

  • Hospital Universitario Donostia

    Donostia / San Sebastian, 20014

  • Complejo Asistencial Universitario de Leon

    León, 24071

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital (Universitario) Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital (Universitario) Marqués de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Consorcio Hospital General Universitario

    Valencia, 46014

  • Hospital Universitario La Fe.

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany17 sites

  • Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III

    Aachen, 52074

  • Charite Universitätsmedizin Campus Virchow

    Berlin, 13353

  • St. Josef-Hospital, Ruhr University Bochum

    Bochum, 44791

  • University Hosptial Cologne Clinics for Gastroenterology and Hepatology

    Cologne, 50937

  • Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1

    Erlangen, Bavaria, 91054

  • University Hospital Essen

    Essen, 45147

  • Katholische Kliniken Ruhrhalbinsel GmbH

    Essen, 45257

  • Universitätsklinikum Hamburg- Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie

    Heidelberg, Baden-Wurttemberg, 69120

  • Gastroenterologische Gemeinschaftspraxis

    Herne, 44623

  • Hepato-Gastroenterology Center Kiel

    Kiel, 24146

  • Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie

    Leipzig, Saxony, 04103

  • EUGASTRO GmbH

    Leipzig, 04103

  • Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik

    Mainz, Rhineland-Palatinate, 55131

  • Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie

    Munich, 80639

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Canada13 sites

  • University of Calgary Liver Unit

    Calgary, T2N 4Z6

  • GI Research

    Edmonton, T5H 4B9

  • University of Alberta

    Edmonton, T6G 2X8

  • London Health Sciences Centre University Hospital

    London, Ontario, N6A 5A5

  • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal

    Montreal, H2X 0A9

  • The Research Institute of the McGill University Health Centre

    Montreal, H4A 3J1

  • Toronto Center for Liver Disease

    Toronto, M5G 2C4

  • Toronto Liver Centre

    Toronto, M6H 3M1

  • LAIR Centre

    Vancouver, V5Z 1H3

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, V5Z 1M9

  • GIRI - GI Research Institute

    Vancouver, V6Z 2K5

  • PerCuro Clinical Research Ltd.

    Victoria, V8V 3M9

  • John Buhler Research Centre

    Winnipeg, R3E 3P4

Other trials in Canada

Australia12 sites

  • Royal Adelaide Hospital Gastroenterology and Hepatology Dept.

    Adelaide, 5000

  • Flinders Medical Centre

    Bedford Park, 5042

  • AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital

    Camperdown, 2050

  • Monash Health - Monash Medical Centre

    Clayton, 3168

  • Gallipoli Medical Research Foundation

    Greenslopes, 4120

  • Austin Hospital

    Heidelberg, 3084

  • Royal Brisbane and Women's Hospital

    Herston, 4029

  • Nepean Hospital

    Kingswood, 2747

  • The Alfred Hospital, Department of Gastroenterology

    Melbourne, 3004

  • Fiona Stanley Hospital

    Murdoch, 6150

  • The Royal Melbourne Hospital

    Parkville, 3053

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

Italy12 sites

  • Universita di Bologna - DIMEC

    Bologna, 40138

  • University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC

    Bologna, 40138

  • Ospedale san Giuseppe - Multimedica

    Milan, 20123

  • Fondazione IRCCS Ca Granda Ospedale

    Milan, 20122

  • Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo

    Milan, 20142

  • Fondazione IRCCS Ca Grande Ospedale

    Milan

  • AOU di Modena Ospedale Civile

    Modena, 41126

  • Azienda Ospedaliera Universitaria Policlinico

    Naples, 80131

  • Policlinico Paolo Giaccone di Palermo

    Palermo, 90127

  • Policlinico University Campus Biomedico

    Rome, 00128

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • A.O.U. Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Israel10 sites

  • Soroka Medical Center Division of Internal Medicine

    Beersheba, 84101

  • Rambam Medical Center Center for Liver diseases

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 34362

  • Shaarei Zedek Medical Center

    Jerusalem, 03235

  • Hadassah Ein Kerem MC

    Jerusalem, 91120

  • West Galilee Hospital

    Nahariya, 22100

  • Holy Family Medical Center

    Nazareth, 16100

  • Rabin Medical Center, Liver Institute

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 52621

  • Sourasky Tel-Aviv Medical Center

    Tel Aviv, 64239

Other trials in Israel

Belgium8 sites

  • AZ Sint-Jan Brugge Oostende

    Bruges, B-8000

  • ULB Hȏpital Erasme - Gastroenterology

    Brussels, Brabant, 1070

  • UCL Saint-Luc - Hepatology Department

    Brussels, 1200

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • Ziekenhuis Oost-Limburg (ZOL)

    Genk, 3600

  • UZ Gent Gastroenterology Department

    Ghent, 9000

  • UZ Leuven Campus Gathuisberg Hepatology Department

    Leuven, Vlaams-Brabant, 3000

  • AZ Nikolaas

    Sint-Niklaas, 9100

Other trials in Belgium

Austria5 sites

  • Universitätsklinik für Innere Medizin I Innsbruck

    Innsbruck, 6020

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

  • Ordensklinikum Linz GmbH

    Linz, 4010

  • Uniklinikum Salzburg

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Poland5 sites

  • Centrum Badan Klinicznych PI-House Sp. z o.o.

    Gdansk, 80-546

  • Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40-752

  • Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego

    Lodz, 91-347

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Lublin, 20-081

  • Centrum Badan Klinicznych Piotr Napora

    Wroclaw, 51-349

Other trials in Poland

Portugal5 sites

  • Centro Hospitalar do Baixo Vouga, E.P.E.

    Aveiro, 3814-201

  • Ulsba, Epe

    Beja, 7801-849

  • Hospital da Senhora da Oliveira - Guimarães

    Guimarães, 4835-044

  • Centro Hospitalar Lisboa Ocidental

    Lisbon, 1349-019

  • Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria

    Lisbon, 1649-035

Other trials in Portugal

Denmark4 sites

  • Aalborg University Hospital

    Aalborg, 9001

  • Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling

    Aarhus, 8200

  • Copenhagen University Hospital Hvidovre

    Hvidovre, 2650

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Switzerland4 sites

  • UVCM Hepatologie

    Bern, 3010

  • Epatocentro Ticino

    Lugano, 6900

  • Hospital of St. Gallen

    Sankt Gallen, 9007

  • University Clinic of Gastroenterology & Hepatology

    Zurich, 8091

Other trials in Switzerland

Hungary3 sites

  • Egyesitett Szent Istvan és Szent Laszlo

    Budapest, 1097

  • Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz

    Budapest, 7624

  • Kenezy Gyula Korhaz es Rendelointezet

    Debrecen, 4031

Other trials in Hungary

Puerto Rico3 sites

  • Klinical Investigations Group, LLC

    San Juan, 00909

  • Ave Ponce De Leon #715

    San Juan, 00918

  • Fundacion de Investigacion

    San Juan, 00927

Other trials in Puerto Rico

Serbia3 sites

  • University Medical Centar Zvezdara

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg, SE-413 45

  • Universitetsjukhuset Linkoping

    Linköping, SE-581 85

  • Karolinska University Hospital

    Stockholm, SE-141 86

Other trials in Sweden

Finland2 sites

  • Helsinki University Hospital

    Helsinki, 00290

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

New Zealand2 sites

  • Middlemore Hospital

    Auckland, 2025

  • NZ Liver Transplant Unit

    Grafton, Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Being tested
Obeticholic Acid, Placebo
Keywords
Non Alcoholic Steatohepatitis, fatty liver disease, NASH
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

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

  • Obeticholic AcidDrug

  • PlaceboDrug

Study groups in NCT02548351
Study groupRoleWhat they receive
10 mg Obeticholic AcidExperimental10 mg Obeticholic Acid daily for the remainder of the study
Receives: Drug: Obeticholic Acid
25 mg Obeticholic AcidExperimental25 mg Obeticholic Acid daily for the remainder of the study
Receives: Drug: Obeticholic Acid
PlaceboPlacebo comparatorOne tablet daily for the remainder of the study
Receives: Drug: Placebo

What is being measured

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

  1. Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event

    All potential liver-related clinical outcomes that occurred after administration of first dose of investigational product were reviewed and adjudicated by blinded, independent Hepatic Outcomes Committee(HOC). Adjudicated results were used to assess effect of OCA, compared to placebo in conjunction with established local standard of care, on clinical outcomes in participants with NASH as measured by time to first occurrence of any of following adjudicated events, derived as a composite event endpoint of death(all-cause), liver transplant, Model of End-stage Liver Disease(MELD)≥15 Score, hospitalization(defined by a stay of 24 hours or greater) for onset of: variceal bleed, hepatic encephalopathy(defined by a West Haven score of ≥2), and spontaneous bacterial peritonitis(confirmed by diagnostic paracentesis), ascites secondary to cirrhosis requiring medical intervention, and histological progression to Cirrhosis. Clinical events distribution was estimated using Kaplan-Meier methodology.

    Measured: Up to 7 years

Secondary outcomes (3)

  1. Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies

    Fibrosis stage was evaluated by NASH Clinical Research Network (CRN) Fibrosis Staging System as follows: Stage 0: No fibrosis, Stage 1: Perisinusoidal/periportal fibrosis, Stage 1A: Mild, zone 3, perisinusoidal fibrosis, Stage 1B: Moderate, zone 3, perisinusoidal fibrosis, Stage 1C: Portal/periportal fibrosis, Stage 2: Perisinusoidal and portal/periportal fibrosis, Stage 3: Bridging fibrosis and Stage 4: Cirrhosis. No worsening of NASH was defined as no worsening of hepatocellular ballooning, no worsening of lobular inflammation, and no worsening of steatosis. Responders are defined as participants who did not discontinue treatment due to Adverse event (AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct the confidence intervals.

    Measured: Up to 7 years

  2. Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method

    Fibrosis stage was evaluated by NASH Clinical Research Network(CRN) Fibrosis Staging System as follows: Stage 0:No fibrosis, Stage 1:Perisinusoidal/periportal fibrosis, Stage 1A:Mild, zone 3, perisinusoidal fibrosis, Stage 1B:Moderate, zone3, perisinusoidal fibrosis, Stage 1C:Portal/periportal fibrosis, Stage 2:Perisinusoidal and portal/periportal fibrosis, Stage 3:Bridging fibrosis and Stage 4:Cirrhosis. Resolution of NASH (Nonalcoholic Steatohepatitis) is defined as absence of fatty liver disease, or presence of simple or isolated steatosis without steatohepatitis, with a NAS(NAFLD Activity Score) of 0 for ballooning and 0 to 1 for inflammation. NAS ranges from 0-12; 0: no features of fatty liver disease and 12: highest degree of fatty liver disease. Higher signify worse symptoms. Responders are who did not discontinue treatment due to Adverse event(AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct confidence intervals.

    Measured: Up to 7 years

  3. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as any AE that either newly appeared, increased in frequency, or worsened in severity following treatment up to 30 days from last dose of permanent investigational product discontinuation. Serious AE (SAE) was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event.

    Measured: Up to 7 years

Timeline

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

  1. First posted14 Sep 2015 (estimated)
  2. Study start22 Sep 2015
  3. Primary completion15 Sep 2023
  4. Study completion15 Sep 2023

Why it stopped: The FDA issued a CRL in response to Intercept's NDA for OCA for the treatment of NASH. Sponsor decided to terminate 747-303 before the planned completion date.

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
2,477 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02548351
Sponsor's protocol ID
747-303
Acronym
REGENERATE
Status last verified
Sep 2024
First submitted
1 Sep 2015
Last updated
1 Oct 2024
Data monitoring committee
Yes

Publications

  • Sanyal AJ, Loomba R, Anstee QM, Ratziu V, Kowdley KV, Rinella ME, Harrison SA, Resnick MB, Capozza T, Sawhney S, Shelat N, Younossi ZM. Utility of pathologist panels for achieving consensus in NASH histologic scoring in clinical trials: Data from a phase 3 study. Hepatol Commun. 2023 Dec 22;8(1):e0325. doi: 10.1097/HC9.0000000000000325. eCollection 2024 Jan 1.

    PubMed 38126958

  • Rinella ME, Dufour JF, Anstee QM, Goodman Z, Younossi Z, Harrison SA, Loomba R, Sanyal AJ, Bonacci M, Trylesinski A, Natha M, Shringarpure R, Granston T, Venugopal A, Ratziu V. Non-invasive evaluation of response to obeticholic acid in patients with NASH: Results from the REGENERATE study. J Hepatol. 2022 Mar;76(3):536-548. doi: 10.1016/j.jhep.2021.10.029. Epub 2021 Nov 15.

    PubMed 34793868

  • Younossi ZM, Stepanova M, Nader F, Loomba R, Anstee QM, Ratziu V, Harrison S, Sanyal AJ, Schattenberg JM, Barritt AS, Noureddin M, Bonacci M, Cawkwell G, Wong B, Rinella M; RandomizEd Global Phase 3 Study to Evaluate the Impact on NASH with FibRosis of Obeticholic Acid TreatmEnt (REGENERATE) Study Investigators. Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2050-2058.e12. doi: 10.1016/j.cgh.2021.07.020. Epub 2021 Jul 15.

    PubMed 34274514

  • Younossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, Bedossa P, Geier A, Beckebaum S, Newsome PN, Sheridan D, Sheikh MY, Trotter J, Knapple W, Lawitz E, Abdelmalek MF, Kowdley KV, Montano-Loza AJ, Boursier J, Mathurin P, Bugianesi E, Mazzella G, Olveira A, Cortez-Pinto H, Graupera I, Orr D, Gluud LL, Dufour JF, Shapiro D, Campagna J, Zaru L, MacConell L, Shringarpure R, Harrison S, Sanyal AJ; REGENERATE Study Investigators. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Dec 14;394(10215):2184-2196. doi: 10.1016/S0140-6736(19)33041-7. Epub 2019 Dec 5.

    PubMed 31813633

  • Ratziu V, Sanyal AJ, Loomba R, Rinella M, Harrison S, Anstee QM, Goodman Z, Bedossa P, MacConell L, Shringarpure R, Shah A, Younossi Z. REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis. Contemp Clin Trials. 2019 Sep;84:105803. doi: 10.1016/j.cct.2019.06.017. Epub 2019 Jun 29.

    PubMed 31260793

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Obeticholic Acid in people with Non Alcoholic Steatohepatitis (NASH), run by Intercept Pharmaceuticals at 346 sites in 21 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 8 inclusion and 13 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 346 sites in United States, United Kingdom, France, Spain, Germany and 16 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 5 Sep 2024). 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?

Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event (time frame: Up to 7 years). 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 NCT02548351, which also lists 5 linked publications.

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 1 Oct 2024.

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