Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical 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).
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
PBC (Primary Biliary Cholangitis)
Enrollment Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.