Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC

June 17, 2026 updated by: Intercept Pharmaceuticals

A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
    • Perth
      • Bedford Park, Perth, Australia, 5042
        • Flinders Medical Centre
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg
  • Croatia
      • Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava
      • Zagreb, Croatia, 10000
        • Zagreb University Hospital Center
  • Czechia
      • Hradec Králové, Czechia, 500 12
        • Hepato-gastroenterologie HK, s.r.o.
      • Ostrava, Czechia, 722 00
        • Artroscan s.r.o., Gastroenterologicka ambulance
      • Pilsen, Czechia, 301 00
        • Research Site s.r.o.
  • Estonia
      • Tartu, Estonia, 51014
        • Tartu University Hospital
  • France
      • Créteil, France, 940000
        • Hopital Henri Mondor
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire Grenoble
      • Lille, France, 59000
        • CHRU de Lille
      • Paris, France, 75651
        • Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris
      • Paris, France, Paris 12
        • CHU Paris Est - Hopital Saint Antoine
  • Germany
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf UKE
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
  • Greece
      • Larissa, Greece, 41110
        • Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa
  • Hungary
      • Budapest, Hungary, 1111
        • Budai Hepatologiai Centrum (BHC)
      • Debrecen, Hungary, 4032
        • DEOEC II. sz. Belgyógyászati Klinika
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Ein-Karem Medical Center - Liver unit
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Surasky Medical Center
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences, Kauno Klinikos
      • Vilnius, Lithuania, 08661
        • Vlinius University
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
  • Norway
      • Loerenskog, Norway, 1478
        • Universitetet i Oslo - Akershus Universitetssykehus (AHUS)
  • Poland
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej
  • South Korea
      • Busan, South Korea, 602-739
        • Pusan National University Hospital
      • Daegu, South Korea, 41944
        • Kyungpook National University Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Fundacio Clinic Per La Recerca Biomedica
      • Valencia, Spain, 46010
        • Consorcio Hospital General Universitario
  • United Kingdom
      • Hull, United Kingdom, HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust
      • Newcastle upon Tyne, United Kingdom, NE2 4HH
        • Institute of Cellular Medicine, Newcastle University
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A definite or probable diagnosis of PBC
  • Qualifying ALP and/or bilirubin liver biochemistry values
  • Taking Ursodeoxycholic Acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1

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
  • Treatment with commercially available OCA or other farnesoid X receptor (FXR) agonists, or participation in a previous study involving OCA within 3 months before Screening.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Treatment A: BZF 200 milligrams (mg) Immediate release (IR)
Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo
Drug: Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study
Drug: OCA Placebo
One tablet daily for the remainder of the study
Drug: Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
Active Comparator: Treatment B: BZF 400 mg SR
Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo
Drug: OCA Placebo
One tablet daily for the remainder of the study
Drug: Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study
Drug: Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Experimental: Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR
Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo
Drug: Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study
Drug: Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
Drug: Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
Experimental: Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR
Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo
Drug: Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study
Drug: Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Drug: Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
Experimental: Long-term safety extension (LTSE) phase: OCA + BZF
Participants will continue the original treatment assignment allocated during the DB Period. The OCA and BZF dose may be optimized based on safety and efficacy during the DB period.
Drug: OCA
OCA one tablet will be administered.
Drug: Bezafibrate
Bezafibrate one tablet will be administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Alkaline Phosphatase (ALP) From Baseline in the Double-Blind Treatment Period
Time Frame: Baseline to Week 12
Serum samples were collected at scheduled visits during the double-blind treatment period. Changes in ALP over time will be analyzed using a mixed model for repeated measures (MMRM) to assess treatment group effects across study visits. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. Change from Baseline was calculated as post Baseline value minus Baseline value.
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP in the Double-Blind Treatment Period
Time Frame: Week 12
Responders were defined as participants achieving a ≥10%, ≥20%, ≥30%, or ≥40% reduction from baseline in serum ALP at Week 12 with non-responder imputation applied. Baseline ALP was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. The percentage of responders were summarized by treatment group for each response threshold and compared using a Cochran Mantel Haenszel test stratified by the randomization stratification factor.
Week 12
Normalization Rates of ALP at Week 12 in the Double-Blind Treatment Period
Time Frame: Week 12
Percentage of participants achieving a response in serum ALP at Week 12 was assessed using non-responder imputation. Analyses of ALP response rates and normalization rates were performed using a Cochran-Mantel-Haenszel test stratified by the randomization stratification factor.
Week 12
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
Time Frame: Week 12
Percentage of participants achieving a response in biochemical disease markers including Alanine Aminotransferase (ALT), Gamma-Glutamyl Transpeptidase (GGT), Aspartate Aminotransferase (AST), Total and conjugated Bilirubin and lipid panel (cholesterol, high density lipoprotein [HDL] and low-density lipoprotein [LDL]) at Week 12 has been presented. Analyses of response rates and normalization rates were performed using a Cochran-Mantel-Haenszel test stratified by the randomization stratification factor.
Week 12
Change From Baseline in GGT, ALT and AST Levels in the Double-Blind Treatment Period
Time Frame: Baseline and at Week 12
Blood samples were collected at indicated timepoint and change from Baseline in GGT, ALT and AST were analyzed using the MMRM model and results were summarized in standard International System of Units (SI) by treatment group using descriptive statistics at baseline and at each on-study evaluation. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. Change from baseline was calculated as post baseline value minus baseline value.
Baseline and at Week 12
Change From Baseline in Total and Conjugated Bilirubin in the Double-Blind Treatment Period
Time Frame: Baseline and at Week 12
Blood samples were collected at indicated timepoints and the changes in total and conjugated bilirubin were evaluated using MMRM to assess the effects of treatment groups over time. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. Change from baseline was calculated as post baseline value minus baseline value.
Baseline and at Week 12
Change From Baseline in Lipid Panel in the Double-Blind Treatment Period
Time Frame: Baseline and at Week 12
Blood samples were collected at indicated timepoints and the changes in lipid panel including cholesterol, HDL and LDL were evaluated using MMRM to assess the effects of treatment groups over time. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product in the DB period. Change from Baseline was calculated as post Baseline value minus Baseline value.
Baseline and at Week 12
Change From Baseline in 7 Alpha (α) Hydroxy 4 Cholesten-3 One (C4) in the Double-Blind Treatment Period
Time Frame: Baseline and at Week 12
Blood samples were collected at indicated timepoints for the assessment of C4. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from Baseline was calculated as change equals post baseline value minus baseline value.
Baseline and at Week 12
Change From Baseline in Bile Acid in the Double-Blind Treatment Period
Time Frame: Baseline and at Week 12
Blood samples were collected for the assessment of bile acids. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from Baseline was calculated as change equals post Baseline value minus Baseline value.
Baseline and at Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intercept Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lynda Szczech, Intercept Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 747-213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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