To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

May 12, 2026 updated by: Intercept Pharmaceuticals

A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina
        • Hospital Universitario Austral
      • Buenos Aires, Argentina
        • DIM Clínica Privada
      • Buenos Aires, Argentina
        • Hospital Italiano de La Plata
      • Santa Fe, Argentina
        • Hospital Provincial del Centenario
  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Division of Gastroenterology Zeidler Ledcor Centre
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Pacific Gastroenterology Associates GI Research Institute
  • Croatia
      • Zagreb, Croatia, 10 000
        • Universityl Hospital Dubrava
  • Czechia
      • Hradec Králové, Czechia, 50012
        • Hepato-gastroenterologie HK, s.r.o.
      • Ostrava, Czechia, 722100
        • Artroscan s.r.o. Gastroenterologicka
      • Pilsen, Czechia, 30100
        • Research Site SRO
  • Estonia
      • Tartu, Estonia, 50090
        • Tartu University Hospital
  • France
      • Créteil, France, 94000
        • Hopital Henri Mondor
      • Lille, France, 59000
        • CHRU de Lille
      • Paris, France, 75013
        • Hôpital de la Pitié Salpêtrière
      • Paris, France, 75012
        • CHU Paris Est - Hopital Saint Antoine
  • Germany
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
  • Greece
      • Larissa, Greece, 41110
        • University Hospital of Larissa
  • Hungary
      • Debrecen, Hungary, 4032
        • DEOEC II. sz. Belgygyszati Klinika
  • Israel
      • Jerusalem, Israel, 9112001
        • Hadassah Ein-Karem Medical Center - Liver unit
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
  • Lithuania
      • Vilnius, Lithuania, 8661
        • University Hopital Santaros klinikos
  • Netherlands
      • Amsterdam, Netherlands, 1005 AZ
        • Academisch Medisch Centrum
  • Norway
      • Lørenskog, Norway, 1478
        • Akershus University Hospital
  • South Korea
      • Daegu, South Korea, 41944
        • Kyungpook National University Hospital
      • Seongnam-si, South Korea, 463-707
        • Seoul National University Bundang Hospital
  • Spain
      • Barcelona, Spain, 8036
        • Hospital ClinicUniversity of Barcelona
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology
      • Bornova, Turkey (Türkiye)
        • Ege University, Faculty of Medicine, Gastroenterology
      • Istanbul, Turkey (Türkiye)
        • Istanbul University, Capa Faculty of Medicine, Gastroenterology
      • Sanliurfa, Turkey (Türkiye)
        • Harran University Hospital, Gastroenterology
  • United Kingdom
      • Hull, United Kingdom, HU32JZ
        • Hull University Teaching Hospitals NHS Trust
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Institute of Cellular Medicine Newcastle University
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Coronado, California, United States, 92118
        • Southern California Research Center
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Medical Group
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Research Institute
    • Texas
      • Dallas, Texas, United States, 75203
        • The Liver Institute at Methodist Dallas Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • San Antonio, Texas, United States, 78215
        • American Research Corporation

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311).

Exclusion Criteria:

  • History or presence of other concomitant liver diseases
  • Clinical complications of PBC
  • History or presence of hepatic decompensating events
  • Current or history of gallbladder disease
  • If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCA 5 mg + BZF 400 mg SR
Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily.
Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR)
Participants will be administered with FDC tablets once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation
Time Frame: Early Termination (Up to Month 12)
A TEAE was defined as any event not present before the initiation of the investigational product in this study or any event already present, which worsened in either severity or frequency following exposure to the investigational product in this study. A serious TEAE was defined as any untoward medical occurrence that at any dose resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality or birth defect, an important medical event that may jeopardize the participant or may require medical intervention.
Early Termination (Up to Month 12)
Number of Participants Reporting Severe TEAEs
Time Frame: Early Termination (Up to Month 12)
A severe (Grade 3) TEAE is defined as an AE that causes inability to carry out usual activities; the subject may experience intolerable discomfort or pain.
Early Termination (Up to Month 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting All-Cause Mortality
Time Frame: Early Termination (Up to Month 12)
All-cause mortality included all reported deaths of participants during the study due to any cause.
Early Termination (Up to Month 12)
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Time Frame: Early Termination (Up to Month 12)
Clinically notable shift from baseline in blood hematology parameters data was presented for low and high numbers of participants at early termination visit (up to Month 12). The number of participants with clinically notable shift from baseline was presented.
Early Termination (Up to Month 12)
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Time Frame: Early Termination (Up to Month 12)
Clinically notable shift from baseline in blood serum chemistry data were presented for low and high numbers of participants at early termination visit (up to Month 12). Change from baseline was calculated as post baseline value minus baseline value. Baseline was defined as the last assessment performed before the first dose of investigational product in Study 977-311.
Early Termination (Up to Month 12)

Collaborators and Investigators

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

Sponsor

Intercept Pharmaceuticals

Investigators

  • Study Director: Lynda Szczech, PhD, Intercept Pharmaceuticals Inc.

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 (Actual)

July 1, 2024

Primary Completion (Actual)

October 21, 2025

Study Completion (Actual)

October 21, 2025

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 977-311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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