MedTrace Logo

Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC

NCT05239468 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-09-25

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Bezafibrate 100 mg

One tablet of bezafibrate 100 mg IR once daily

DRUG

Bezafibrate 200 mg

Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR

DRUG

Obeticholic Acid 5 mg

One tablet of obeticholic acid 5 mg tablet once daily.

DRUG

Obeticholic Acid placebo

One tablet of obeticholic acid placebo tablet once daily

DRUG

Bezafibrate Placebo

One tablet of bezafibrate placebo tablet once daily

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lynda Szczech, M.D. · Intercept Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2025-09-01
Completion
2025-09-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05239468 on ClinicalTrials.gov