Primary Biliary CholangitisPhase 3NCT06488911
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
A Phase 3 study testing FDC tablet (OCA 5 mg + BZF 400 mg SR) in people with Primary Biliary Cholangitis, run by Intercept Pharmaceuticals at 51 sites in 21 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 51 sitesin 21 countries
- Study dates
- 1 Jul 2024to 21 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
51 sites in 21 countries.
51 sites in 21 countries
United States13 sites
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Southern California Research Center
Coronado, California, 92118
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
Gastro One
Germantown, Tennessee, 38138
Houston Methodist Hospital
Houston, Texas, 77030
East Tennessee Research Institute
Johnson City, Tennessee, 37604
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
NYU Langone Health
New York, New York, 10016
American Research Corporation
San Antonio, Texas, 78215
Tampa General Medical Group
Tampa, Florida, 33606
Argentina5 sites
DIM Clinica Privada
Buenos Aires
Hospital Italiano de Buenos Aires
Buenos Aires
Hospital Italiano de La Plata
Buenos Aires
Hospital Universitario Austral
Buenos Aires
Hospital Provincial del Centenario
Santa Fe
France4 sites
Hopital Henri Mondor
Créteil, 94000
CHRU de Lille
Lille, 59000
CHU Paris Est - Hopital Saint Antoine
Paris, 75012
Hopital de la Pitie Salpetriere
Paris, 75013
Turkey (Türkiye)4 sites
Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology
Ankara
Ege University, Faculty of Medicine, Gastroenterology
Bornova
Istanbul University, Capa Faculty of Medicine, Gastroenterology
Istanbul
Harran University Hospital, Gastroenterology
Sanliurfa
Czechia3 sites
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012
Artroscan s.r.o. Gastroenterologicka
Ostrava, 722100
Research Site SRO
Pilsen, 30100
United Kingdom3 sites
Hull University Teaching Hospitals NHS Trust
Hull, HU32JZ
Institute of Cellular Medicine Newcastle University
Newcastle upon Tyne, NE7 7DN
John Radcliffe Hospital
Oxford, OX3 9DU
Australia2 sites
Royal Adelaide Hospital
Adelaide, 5000
Flinders Medical Centre
Bedford Park, 5042
Canada2 sites
University of Alberta Division of Gastroenterology Zeidler Ledcor Centre
Edmonton, Alberta
Pacific Gastroenterology Associates GI Research Institute
Vancouver, British Columbia
South Korea2 sites
Kyungpook National University Hospital
Daegu, 41944
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Spain2 sites
Hospital ClinicUniversity of Barcelona
Barcelona, 8036
Consorcio Hospital General Universitario
Valencia, 46014
Italy1 site
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna
About this study
Official title: 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).
- Conditions
- Primary Biliary Cholangitis
- Being tested
- FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Keywords
- Primary Biliary Cholangitis, Obeticholic Acid, Bezafibrate, Ursodeoxycholic acid
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC tablet (OCA 5 mg + BZF 400 mg SR)Drug
Participants will be administered with FDC tablets once daily.
| Study group | Role | What they receive |
|---|---|---|
| OCA 5 mg + BZF 400 mg SR | Experimental | Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily. Receives: Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation
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.
Measured: Early Termination (Up to Month 12)
Number of Participants Reporting Severe TEAEs
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.
Measured: Early Termination (Up to Month 12)
Secondary outcomes (3)
Number of Participants Reporting All-Cause Mortality
All-cause mortality included all reported deaths of participants during the study due to any cause.
Measured: Early Termination (Up to Month 12)
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
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.
Measured: Early Termination (Up to Month 12)
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
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.
Measured: Early Termination (Up to Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jul 2024
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Why it stopped: Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intercept Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynda Szczech, PhD, Study director, Intercept Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488911
- Sponsor's protocol ID
- 977-311
- Status last verified
- May 2026
- First submitted
- 28 Jun 2024
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06488911
- Acronym / sponsor ID
- 977-311
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Primary Biliary Cholangitis, Obeticholic Acid, Bezafibrate, Ursodeoxycholic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Intercept PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Posted 8 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCA 5 mg + BZF 400 mg SR | Experimental | Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR)Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDC tablet (OCA 5 mg + BZF 400 mg SR)Participants will be administered with FDC tablets once daily. | Drug | OCA 5 mg + BZF 400 mg SR |
Primary outcome
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.
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.
3 secondary outcomes
Number of Participants Reporting All-Cause Mortality
Time frame: 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)
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
Time frame: Early Termination (Up to Month 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynda Szczech, PhD study director
Intercept Pharmaceuticals Inc.
51 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FDC tablet (OCA 5 mg + BZF 400 mg SR) in people with Primary Biliary Cholangitis, run by Intercept Pharmaceuticals at 51 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 1 inclusion and 6 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Argentina, France, Turkey (Türkiye), Czechia 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. 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 8 Jun 2026). 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 Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation (time frame: Early Termination (Up to Month 12)). 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?
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 8 Jun 2026.