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Clinical trialNCT02548351TerminatedPhase 3Interventional

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

SponsorIntercept PharmaceuticalsEnrollment2,477Non Alcoholic Steatohepatitis (NASH)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

346 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Royal Adelaide Hospital Gastroenterology and Hepatology Dept.

    Adelaide, Australia

  • Flinders Medical Centre

    Bedford Park, Australia

  • Aw Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital

    Camperdown, Australia

  • Monash Health - Monash Medical Centre

    Clayton, Australia

  • Gallipoli Medical Research Foundation

    Greenslopes, Australia

  • Austin Hospital

    Heidelberg, Australia

  • Royal Brisbane and Women'S Hospital

    Herston, Australia

  • Nepean Hospital

    Kingswood, Australia

  • the Alfred Hospital, Department of Gastroenterology

    Melbourne, Australia

  • Fiona Stanley Hospital

    Murdoch, Australia

  • the Royal Melbourne Hospital

    Parkville, Australia

  • Westmead Hospital

    Westmead, Australia

Austria
  • Universitätsklinik Für Innere Medizin I Innsbruck

    Innsbruck, Austria

  • Klinikum Klagenfurt Am Wörthersee

    Klagenfurt, Austria

  • Ordensklinikum Linz Gmbh

    Linz, Austria

  • Uniklinikum Salzburg

    Salzburg, Austria

  • Medizinische Universität Wien

    Vienna, Austria

Belgium
  • Uz Antwerpen

    Edegem, Antwerpen, Belgium

  • Ulb Hȏpital Erasme - Gastroenterology

    Brussels, Brabant, Belgium

  • Uz Leuven Campus Gathuisberg Hepatology Department

    Leuven, Vlaams-Brabant, Belgium

  • Az Sint-Jan Brugge Oostende

    Bruges, Belgium

  • Ucl Saint-Luc - Hepatology Department

    Brussels, Belgium

  • Ziekenhuis Oost-Limburg (zol)

    Genk, Belgium

  • Uz Gent Gastroenterology Department

    Ghent, Belgium

  • Az Nikolaas

    Sint-Niklaas, Belgium

Canada
  • London Health Sciences Centre University Hospital

    London, Ontario, Canada

  • University of Calgary Liver Unit

    Calgary, Canada

  • Gi Research

    Edmonton, Canada

  • University of Alberta

    Edmonton, Canada

  • Centre de Recherche Du Centre Hospitalier de L'Universite de Montreal

    Montreal, Canada

  • the Research Institute of the Mcgill University Health Centre

    Montreal, Canada

  • Toronto Center for Liver Disease

    Toronto, Canada

  • Toronto Liver Centre

    Toronto, Canada

  • Giri - Gi Research Institute

    Vancouver, Canada

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, Canada

  • Lair Centre

    Vancouver, Canada

  • Percuro Clinical Research Ltd.

    Victoria, Canada

  • John Buhler Research Centre

    Winnipeg, Canada

Denmark
  • Aalborg University Hospital

    Aalborg, Denmark

  • Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling

    Aarhus, Denmark

306 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Obeticholic acidPlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
22 Sept 2015
Primary completion
15 Sept 2023
Completion
15 Sept 2023
Last update posted
1 Oct 2024
Registered enrollment
2,477
Registry id
NCT02548351

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.