Primary Biliary CholangitisPhase 2NCT05239468
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
A Phase 2 study testing Bezafibrate 100 mg, Bezafibrate 200 mg and Obeticholic Acid 5 mg in people with Primary Biliary Cholangitis, run by Intercept Pharmaceuticals at 26 sites in 4 countries.
Trial summary
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) 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?
- Bezafibrate 100 mg, Bezafibrate 200 mg and Obeticholic Acid 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 26 sitesin 4 countries
- Study dates
- 21 Mar 2022to 1 Sep 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
- Presence of clinical complications of PBC
- History or presence of 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 participation in a previous study involving OCA, or other farnesoid X receptor (FXR) agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening
- Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
United States17 sites
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Beth Israel Deaconess Medical Center Harvard Liver Research Center
Boston, Massachusetts, 02215
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Gastro One
Cordova, Tennessee, 38018
Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado
Coronado, California, 92118
Methodist Clinical Research Institute (CRI)
Dallas, Texas, 75203
Houston Methodist Cancer Center
Houston, Texas, 77030-2717
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, 37604
Loyola University Medical Center
Maywood, Illinois, 60459
Schiff Center for Liver Diseases / University of Miami
Miami, Florida, 33136
Facey Medical Group
Mission Hills, California, 91345
Ochsner Medical Center
New Orleans, Louisiana, 70121
NYU Langone Medical Center
New York, New York, 10016-6402
Wake Endoscopy Center
Raleigh, North Carolina, 27607
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
Tampa General Medical Group
Tampa, Florida, 33606
Argentina5 sites
Hospital Italiano de Buenos Aires
Buenos Aires
Hospital Italiano La Plata
La Plata, Buenos Aires
Hospital Universitario Austral
Pilar
DIM Clinical Privada
Ramos Mejía, Buenos Aires
Hospital Provincial del Centenario
Rosario
Canada3 sites
The Northern Alberta Clinical Trials and Research Centre
Edmonton, Alberta, T6G 287
University of Montreal
Montreal, Quebec
Pacific Gastroenterology Associates
Vancouver, British Columbia, V6Z 2K5
Italy1 site
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna
About this study
Official title: A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg, Obeticholic Acid placebo, Bezafibrate Placebo
- Keywords
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, 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.
Bezafibrate 100 mgDrug
One tablet of bezafibrate 100 mg IR once daily
Bezafibrate 200 mgDrug
Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR
Obeticholic Acid 5 mgDrug
One tablet of obeticholic acid 5 mg tablet once daily.
Obeticholic Acid placeboDrug
One tablet of obeticholic acid placebo tablet once daily
Bezafibrate PlaceboDrug
One tablet of bezafibrate placebo tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet | Active comparator | Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily. Receives: Drug: Bezafibrate 100 mg; Drug: Obeticholic Acid placebo; Drug: Bezafibrate Placebo |
| Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet | Active comparator | Each Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. Receives: Drug: Bezafibrate 200 mg; Drug: Obeticholic Acid placebo |
| Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR | Experimental | Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily. Receives: Drug: Bezafibrate 100 mg; Drug: Obeticholic Acid 5 mg; Drug: Bezafibrate Placebo |
| Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR | Experimental | Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. Receives: Drug: Bezafibrate 200 mg; Drug: Obeticholic Acid 5 mg |
| Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR | Experimental | Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. Receives: Drug: Bezafibrate 200 mg; Drug: Obeticholic Acid 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Alkaline Phosphatase (ALP)
Serum samples were collected at scheduled visits during the double-blind treatment period. Changes in ALP were evaluated using a mixed-effects repeated-measures model (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. 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
Responders were defined as participants achieving a ≥10%, ≥20%, ≥30%, or ≥40% reduction from baseline in serum ALP at week 12 during the DB treatment period with non-responder imputation applied. Baseline ALP was defined as the last evaluations prior to the first administration of investigational product. 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: At Week 12
Normalization Rates of ALP at Week 12
Percentage of participants achieving a response in serum ALP at week 12 during the DB treatment period was assessed using non-responder imputation. Analyses of ALP normalization rates were performed using a Cochran-Mantel-Haenszel test stratified by the randomization stratification factor.
Measured: At Week 12
Normalization Rates of Biochemical Disease Markers
Percentage of participants achieving a response in biochemical disease markers including ALP, alanine amino transferase (ALT), aspartate amino transferase (AST), gamma-glutamyl transferase (GGT), total and conjugated bilirubin and lipid panel (cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL]) at Week 12 during the DB treatment period 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: At Week 12
Change From Baseline in in GGT, ALT and AST Levels
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. 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
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. Change from baseline was calculated as post Baseline value minus Baseline value.
Measured: Baseline and At Week 12
Change From Baseline in Lipid Panel
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. Change from baseline was calculated as post Baseline value minus Baseline value.
Measured: Baseline and At Week 12
Change From Baseline of the Plasma Value of 7 Alpha (α) Hydroxy 4 Cholesten-3 One (C4)
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 post Baseline value minus Baseline value.
Measured: Baseline and At Week 12
Number of Participants With Clinically Significant Changes From Baseline in Bile Acids
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.
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start21 Mar 2022
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intercept Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynda Szczech, M.D., Study director, Intercept Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239468
- Sponsor's protocol ID
- 747-214
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2022
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT05239468
- Acronym / sponsor ID
- 747-214
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Hepatic Impairment, Cirrhosis, Liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Intercept PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 15 Feb 2022 (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 to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
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 |
|---|---|---|
| Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet | Active comparator | Drug: Bezafibrate 100 mg, Drug: Obeticholic Acid placebo, Drug: Bezafibrate PlaceboEach Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily. |
| Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet | Active comparator | Drug: Bezafibrate 200 mg, Drug: Obeticholic Acid placeboEach Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. |
| Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR | Experimental | Drug: Bezafibrate 100 mg, Drug: Obeticholic Acid 5 mg, Drug: Bezafibrate PlaceboEach participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily. |
| Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR | Experimental | Drug: Bezafibrate 200 mg, Drug: Obeticholic Acid 5 mgEach participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. |
| Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR | Experimental | Drug: Bezafibrate 200 mg, Drug: Obeticholic Acid 5 mgEach participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. |
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 (8 listed)
- History or presence of other concomitant liver diseases
- Presence of clinical complications of PBC
- History or presence of 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 |
|---|---|---|
| Bezafibrate 100 mgOne tablet of bezafibrate 100 mg IR once daily | Drug | Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet, Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR |
| Bezafibrate 200 mgTwo tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR | Drug | Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet, Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR, Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR |
| Obeticholic Acid 5 mgOne tablet of obeticholic acid 5 mg tablet once daily. | Drug | Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR, Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR, Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR |
| Obeticholic Acid placeboOne tablet of obeticholic acid placebo tablet once daily | Drug | Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet, Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet |
| Bezafibrate PlaceboOne tablet of bezafibrate placebo tablet once daily | Drug | Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet, Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR |
Primary outcome
Change From Baseline in Alkaline Phosphatase (ALP)
Time frame: Baseline to Week 12
Serum samples were collected at scheduled visits during the double-blind treatment period. Changes in ALP were evaluated using a mixed-effects repeated-measures model (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. 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
Time frame: At Week 12
Normalization Rates of ALP at Week 12
Time frame: At Week 12
Normalization Rates of Biochemical Disease Markers
Time frame: At Week 12
Change From Baseline in in GGT, ALT and AST Levels
Time frame: Baseline and At Week 12
Change From Baseline in Total and Conjugated Bilirubin
Time frame: Baseline and At Week 12
Change From Baseline in Lipid Panel
Time frame: Baseline and At Week 12
Change From Baseline of the Plasma Value of 7 Alpha (α) Hydroxy 4 Cholesten-3 One (C4)
Time frame: Baseline and At Week 12
Number of Participants With Clinically Significant Changes From Baseline in Bile Acids
Time frame: At Week 12
Results and safety
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.
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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, M.D. study director
Intercept Pharmaceuticals, Inc
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bezafibrate 100 mg, Bezafibrate 200 mg and Obeticholic Acid 5 mg in people with Primary Biliary Cholangitis, run by Intercept Pharmaceuticals at 26 sites in 4 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 8 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: finished, 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 26 sites in United States, Argentina, Canada, Italy. 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 From Baseline in Alkaline Phosphatase (ALP) (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?
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.