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

> **NCT04594694** · PHASE2 · TERMINATED · sponsor: **Intercept Pharmaceuticals** · enrollment: 75 (actual)

## Conditions studied

- Primary Biliary Cholangitis

## Interventions

- **DRUG:** Obeticholic acid
- **DRUG:** Bezafibrate 200 MG
- **DRUG:** OCA Placebo
- **DRUG:** Bezafibrate 200 mg Placebo
- **DRUG:** Bezafibrate 400 MG
- **DRUG:** Bezafibrate 400 mg Placebo
- **DRUG:** OCA
- **DRUG:** Bezafibrate

## Key facts

- **NCT ID:** NCT04594694
- **Lead sponsor:** Intercept Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2019-10-02
- **Primary completion:** 2025-10-14
- **Final completion:** 2025-10-14
- **Target enrollment:** 75 (ACTUAL)
- **Why stopped:** Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.
- **Last updated:** 2025-11-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04594694

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04594694, "Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT04594694. Licensed CC0.

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