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

  • End date
    Sep 28, 2024
  • participants needed
  • sponsor
    Intercept Pharmaceuticals
Updated on 28 October 2022
obeticholic acid


Study to determine the effect of the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF) in patients with Primary Biliary Cholangitis (also known as PBC).

Condition Primary Biliary Cholangitis
Treatment Obeticholic acid, Bezafibrate 200 MG, OCA Placebo, Bezafibrate 200 mg Placebo, Bezafibrate 400 MG, Bezafibrate 400 mg Placebo
Clinical Study IdentifierNCT04594694
SponsorIntercept Pharmaceuticals
Last Modified on28 October 2022


Yes No Not Sure

Inclusion Criteria

A definite or probable diagnosis of PBC
Qualifying ALP and/or bilirubin liver biochemistry values
Taking UDCA for at least 12 months or no UDCA for 3 months before Day 1

Exclusion Criteria

History or presence of other concomitant liver diseases
Clinical complications of PBC
Current or history of gallbladder disease
History or presence of hepatic decompensating events
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
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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