Obeticholic Acid + Bezafibrate for Primary Biliary Cholangitis

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Intercept Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with primary biliary cholangitis.

Qualifying ALP and/or bilirubin liver biochemistry values

I have been on UDCA for 12 months or haven't taken it for 3 months.

Exclusion Criteria

I cannot tolerate fibrates or have not taken them in the last 3 months.

I haven't taken OCA or similar drugs in the last 3 months.

I have or had gallbladder disease.

+4 more

Participant Groups

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.

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