Primary Biliary CholangitisPhase 2NCT04594694

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

A Phase 2 study testing Obeticholic acid, Bezafibrate 200 MG and Bezafibrate 400 MG in people with Primary Biliary Cholangitis, run by Intercept Pharmaceuticals at 33 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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). 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?: Obeticholic acid, Bezafibrate 200 MG and Bezafibrate 400 MG
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 75 participants
Where: 33 sitesin 17 countries
Study dates: 2 Oct 2019to 14 Oct 2025
Phase: Phase 2
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

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

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
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.

Trial locations and contacts

33 sites in 17 countries.

Country

City, postcode or hospital

33 sites in 17 countries

France5 sites

Hôpital Henri Mondor
Créteil, 940000
Centre Hospitalier Universitaire Grenoble
Grenoble, 38043
CHRU de Lille
Lille, 59000
Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris
Paris, 75651
CHU Paris Est - Hopital Saint Antoine
Paris, Paris 12

Other trials in France

Czechia3 sites

Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12
Artroscan s.r.o., Gastroenterologicka ambulance
Ostrava, 722 00
Research Site s.r.o.
Pilsen, 301 00

Other trials in Czechia

United Kingdom3 sites

Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
Institute of Cellular Medicine, Newcastle University
Newcastle upon Tyne, NE2 4HH
John Radcliffe Hospital
Oxford, OX3 9DU

Other trials in United Kingdom

Australia2 sites

Royal Adelaide Hospital
Adelaide, 5000
Flinders Medical Centre
Bedford Park, Perth, 5042

Other trials in Australia

Croatia2 sites

Clinical Hospital Dubrava
Zagreb, 10000
Zagreb University Hospital Center
Zagreb, 10000

Other trials in Croatia

Germany2 sites

Universitatsklinikum Hamburg-Eppendorf UKE
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30625

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Hungary2 sites

Budai Hepatologiai Centrum (BHC)
Budapest, 1111
DEOEC II. sz. Belgyógyászati Klinika
Debrecen, 4032

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Israel2 sites

Hadassah Ein-Karem Medical Center - Liver unit
Jerusalem, 91120
Tel Aviv Surasky Medical Center
Tel Aviv, 6423906

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Lithuania2 sites

Hospital of Lithuanian University of Health Sciences, Kauno Klinikos
Kaunas, 50161
Vlinius University
Vilnius, 08661

Other trials in Lithuania

South Korea2 sites

Pusan National University Hospital
Busan, 602-739
Kyungpook National University Hospital
Daegu, 41944

Other trials in South Korea

Spain2 sites

Fundacio Clinic Per La Recerca Biomedica
Barcelona, 08036
Consorcio Hospital General Universitario
Valencia, 46010

Other trials in Spain

Belgium1 site

UZ Gasthuisberg
Leuven, 3000

Other trials in Belgium

Estonia1 site

Tartu University Hospital
Tartu, 51014

Other trials in Estonia

Greece1 site

Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa
Larissa, 41110

Other trials in Greece

Netherlands1 site

Academisch Medisch Centrum
Amsterdam, 1105 AZ

Other trials in Netherlands

Norway1 site

Universitetet i Oslo - Akershus Universitetssykehus (AHUS)
Loerenskog, 1478

Other trials in Norway

Poland1 site

Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej
Warsaw, 02-781

Other trials in Poland

About this study

Official title: 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

Conditions: Primary Biliary Cholangitis
Being tested: Obeticholic acid, Bezafibrate 200 MG, OCA Placebo, Bezafibrate 200 mg Placebo, Bezafibrate 400 MG
Keywords: Primary Biliary Cholangitis, Primary Biliary Cirrhosis, PBC, Hepatic Impairment, Cirrhosis, Liver
Medical subject headings: Liver Cirrhosis, Biliary, Fibrosis

What participants receive

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

Obeticholic acidDrug
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
Bezafibrate 200 MGDrug
200 mg IR tablet of Bezafibrate once daily for the remainder of the study
OCA PlaceboDrug
One tablet daily for the remainder of the study
Bezafibrate 200 mg PlaceboDrug
One tablet daily for the remainder of the study
Bezafibrate 400 MGDrug
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Bezafibrate 400 mg PlaceboDrug
One tablet daily for the remainder of the study
OCADrug
OCA one tablet will be administered.
BezafibrateDrug
Bezafibrate one tablet will be administered.

Study groups in NCT04594694
Study group	Role	What they receive
Treatment A: BZF 200 milligrams (mg) Immediate release (IR)	Active comparator	Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo Receives: Drug: Bezafibrate 200 MG; Drug: OCA Placebo; Drug: Bezafibrate 400 mg Placebo
Treatment B: BZF 400 mg SR	Active comparator	Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo Receives: Drug: OCA Placebo; Drug: Bezafibrate 200 mg Placebo; Drug: Bezafibrate 400 MG
Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR	Experimental	Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo Receives: Drug: Obeticholic acid; Drug: Bezafibrate 200 MG; Drug: Bezafibrate 400 mg Placebo
Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR	Experimental	Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo Receives: Drug: Obeticholic acid; Drug: Bezafibrate 200 mg Placebo; Drug: Bezafibrate 400 MG
Long-term safety extension (LTSE) phase: OCA + BZF	Experimental	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. Receives: Drug: OCA; Drug: Bezafibrate

What is being measured

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

Change in Alkaline Phosphatase (ALP) From Baseline in the Double-Blind Treatment Period
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.
Measured: Baseline to Week 12

Secondary outcomes (8)

Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP in the Double-Blind Treatment Period
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.
Measured: Week 12
Normalization Rates of ALP at Week 12 in the Double-Blind Treatment Period
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.
Measured: Week 12
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
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.
Measured: Week 12
Change From Baseline in GGT, ALT and AST Levels in the Double-Blind Treatment Period
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.
Measured: Baseline and at Week 12
Change From Baseline in Total and Conjugated Bilirubin in the Double-Blind Treatment Period
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.
Measured: Baseline and at Week 12
Change From Baseline in Lipid Panel in the Double-Blind Treatment Period
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.
Measured: Baseline and at Week 12
Change From Baseline in 7 Alpha (α) Hydroxy 4 Cholesten-3 One (C4) in the Double-Blind Treatment Period
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.
Measured: Baseline and at Week 12
Change From Baseline in Bile Acid in the Double-Blind Treatment Period
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.
Measured: Baseline and at Week 12

Timeline

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

2 Oct 201914 Oct 2025

First posted20 Oct 2020
Study start2 Oct 2019
Primary completion14 Oct 2025
Study completion14 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.
Publications (2)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04594694
Sponsor's protocol ID: 747-213
Status last verified: Jun 2026
First submitted: 14 Jul 2020
Last updated: 16 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.
PubMed 19554543
European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.
PubMed 19501929

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Biliary Cholangitis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04594694
Acronym / sponsor ID: 747-213
Conditions: Primary Biliary Cholangitis
Keywords: Primary Biliary Cholangitis, Primary Biliary Cirrhosis, PBC, Hepatic Impairment, Cirrhosis, Liver
Phase: Phase 2
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: 75 participants (actual)
Lead sponsor: Intercept PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 2 Oct 2019 (actual)
Primary completion: 14 Oct 2025 (actual)
Study completion: 14 Oct 2025 (actual)
First posted: 20 Oct 2020 (actual)
Results: Posted 16 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Treatment A: BZF 200 milligrams (mg) Immediate release (IR)	Active comparator	Drug: Bezafibrate 200 MG, Drug: OCA Placebo, Drug: Bezafibrate 400 mg PlaceboParticipants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo
Treatment B: BZF 400 mg SR	Active comparator	Drug: OCA Placebo, Drug: Bezafibrate 200 mg Placebo, Drug: Bezafibrate 400 MGParticipants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo
Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR	Experimental	Drug: Obeticholic acid, Drug: Bezafibrate 200 MG, Drug: Bezafibrate 400 mg PlaceboParticipants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo
Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR	Experimental	Drug: Obeticholic acid, Drug: Bezafibrate 200 mg Placebo, Drug: Bezafibrate 400 MGParticipants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo
Long-term safety extension (LTSE) phase: OCA + BZF	Experimental	Drug: OCA, Drug: BezafibrateParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 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
Obeticholic acid5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily	Drug	Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR, Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR
Bezafibrate 200 MG200 mg IR tablet of Bezafibrate once daily for the remainder of the study	Drug	Treatment A: BZF 200 milligrams (mg) Immediate release (IR), Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR
OCA PlaceboOne tablet daily for the remainder of the study	Drug	Treatment A: BZF 200 milligrams (mg) Immediate release (IR), Treatment B: BZF 400 mg SR
Bezafibrate 200 mg PlaceboOne tablet daily for the remainder of the study	Drug	Treatment B: BZF 400 mg SR, Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR
Bezafibrate 400 MG400 mg SR tablet of Bezafibrate once daily for the remainder of the study	Drug	Treatment B: BZF 400 mg SR, Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR
Bezafibrate 400 mg PlaceboOne tablet daily for the remainder of the study	Drug	Treatment A: BZF 200 milligrams (mg) Immediate release (IR), Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR
OCAOCA one tablet will be administered.	Drug	Long-term safety extension (LTSE) phase: OCA + BZF
BezafibrateBezafibrate one tablet will be administered.	Drug	Long-term safety extension (LTSE) phase: OCA + BZF

Primary outcome

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.

8 secondary outcomes

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
Normalization Rates of ALP at Week 12 in the Double-Blind Treatment Period
Time frame: Week 12
Normalization Rates of Biochemical Disease Markers in the Double-Blind Treatment Period
Time frame: Week 12
Change From Baseline in GGT, ALT and AST Levels in the Double-Blind Treatment Period
Time frame: 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
Change From Baseline in Lipid Panel in the Double-Blind Treatment Period
Time frame: 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
Change From Baseline in Bile Acid in the Double-Blind Treatment Period
Time frame: Baseline and at Week 12

Results and safety

Results posted to the registry on 16 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo + BZF 200 mg IR	19	17
OCA 5 mg + BZF 200 mg IR	19	17
Placebo + BZF 400 mg SR	19	18
OCA 5 mg + BZF 400 mg SR	18	14

Primary outcome: Change in Alkaline Phosphatase (ALP) From Baseline in the Double-Blind Treatment Period

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: Units per liter (U/L)

Measure	Placebo + BZF 200 mg IR n = 18	OCA 5 mg + BZF 200 mg IR n = 19	Placebo + BZF 400 mg SR n = 19	OCA 5 mg + BZF 400 mg SR n = 17
Value	-111.1 (11.41)	-113.7 (11.07)	-137.4 (15.40)	-184.3 (16.37)

Placebo + BZF 200 mg IR vs OCA 5 mg + BZF 200 mg IR: Least square mean difference: -2.6 (95% CI -34.2 to 28.9), p = 0.869, Mixed Model Repeated Measures
Placebo + BZF 400 mg SR vs OCA 5 mg + BZF 400 mg SR: Least square mean difference: -46.9 (95% CI -92.2 to -1.6), p = 0.043, Mixed Model Repeated Measures

Population analysed: The modified intent-to-treat (mITT) analysis set included all randomized participants who had baseline and at least one post-baseline ALP assessment. Only those participants with data available at specified time points have been presented.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: DB Period: Up to Week 12; LTSE period: Up to Week 120.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DB Period, Placebo + BZF 200 mg IR	2 of 19 (10.5%)	15 of 19 (78.9%)	0 of 19
DB Period, OCA 5 mg + BZF 200 mg IR	1 of 19 (5.3%)	15 of 19 (78.9%)	0 of 19
DB Period, Placebo + BZF 400 mg SR	3 of 19 (15.8%)	16 of 19 (84.2%)	0 of 19
DB Period, OCA 5 mg + BZF 400 mg SR	2 of 18 (11.1%)	14 of 18 (77.8%)	0 of 18
LTSE Period, OCA 5 mg + BZF 400 mg SR	1 of 64 (1.6%)	47 of 64 (73.4%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19554543Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.
Background: PubMed 19501929European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.

Related trials for Primary Biliary Cholangitis

Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
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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 study director

Intercept Pharmaceuticals, Inc.

33 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obeticholic acid, Bezafibrate 200 MG and Bezafibrate 400 MG in people with Primary Biliary Cholangitis, run by Intercept Pharmaceuticals at 33 sites in 17 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 3 inclusion and 7 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in France, Czechia, United Kingdom, Australia, Croatia and 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Jul 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?

Change in Alkaline Phosphatase (ALP) From Baseline in the Double-Blind Treatment Period (time frame: Baseline to Week 12). 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 NCT04594694, which also lists 2 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 16 Jul 2026.