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Fibrate

Obeticholic Acid + Bezafibrate for Primary Biliary Cholangitis

Phase 2
Waitlist Available
Research Sponsored by Intercept Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A definite or probable diagnosis of PBC
Be older than 18 years old
Must not have
Current or history of gallbladder disease
Presence of clinical complications of PBC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial will test the effect of bezafibrate and obeticholic acid on patients with primary biliary cholangitis.

Who is the study for?
This trial is for people with Primary Biliary Cholangitis (PBC) who have been on a drug called UDCA for at least a year, or not at all in the past 3 months. It's not open to pregnant or breastfeeding women, those who can't handle bezafibrate, have other liver diseases, gallbladder disease, or were recently in fibrate/OCA studies.
What is being tested?
The study tests bezafibrate (BZF), alone and combined with obeticholic acid (OCA), against placebos to see their effects on PBC. Participants will receive either BZF at different doses or OCA along with dummy pills to compare results.
What are the potential side effects?
Possible side effects include digestive issues like stomach pain and constipation, itching skin due to increased bile acids if there's blockage of bile flow, muscle pain from statin-like effects of fibrates, and potential liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with primary biliary cholangitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had gallbladder disease.
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I am experiencing complications from primary biliary cholangitis.
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I have or had other liver diseases besides my current condition.
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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IRExperimental Treatment2 Interventions
Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.
Group II: Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IRExperimental Treatment2 Interventions
Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.
Group III: Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IRExperimental Treatment3 Interventions
Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily.
Group IV: Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tabletActive Control3 Interventions
Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily.
Group V: Double Blind (DB) Phase Treatment B: BZF 400 mg IR tabletActive Control2 Interventions
Each Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.

Find a Location

Who is running the clinical trial?

Intercept PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
16,920 Total Patients Enrolled
6 Trials studying Primary Biliary Cholangitis
11,173 Patients Enrolled for Primary Biliary Cholangitis
George Harb, M.D.Study DirectorIntercept Pharmaceuticals, Inc
2 Previous Clinical Trials
94 Total Patients Enrolled
1 Trials studying Primary Biliary Cholangitis
72 Patients Enrolled for Primary Biliary Cholangitis
Lynda Szczech, M.D.Study DirectorIntercept Pharmaceuticals, Inc

Media Library

Bezafibrate (Fibrate) Clinical Trial Eligibility Overview. Trial Name: NCT05239468 — Phase 2
Primary Biliary Cholangitis Research Study Groups: Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR, Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR, 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, Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR
Primary Biliary Cholangitis Clinical Trial 2023: Bezafibrate Highlights & Side Effects. Trial Name: NCT05239468 — Phase 2
Bezafibrate (Fibrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05239468 — Phase 2
~16 spots leftby Jan 2026
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