Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).

A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in Subjects with Primary Biliary Cholangitis - -

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001241-20-IT

Enrollment

Registered

2022-09-14

Start date

2022-11-23

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis MedDRA version: 21.0 Level: PT Classification code 10080429 Term: Primary biliary cholangitis System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: [-] Pharmaceutical Form: Tablet INN or Proposed INN: ACIDO OBETICOLICO CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A define or probable diagnosis of PBC 2. Qualifying ALP and/or bilirubin liver biochemistry values 3. Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. History or presence of other concomitant liver diseases 2. Presence of clinical complications of PBC 3. History or presence of decompensating events 4. Current or history of gallbladder disease 5. If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating 6. Treatment with commercially available OCA or participation in a previous study involving OCA within 3 months before Screening 7. Treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to BZF alone in subjects with PBC;Secondary Objective: The secondary objectives are to assess the effects of the combination of OCA plus BZF versus BZF alone in subjects with PBC on the following: • Biochemical disease markers, including ALP, GGT, ALT, AST, total and conjugated bilirubin, and lipid panel • Biomarkers of bile acid synthesis and homeostasis, including 7a-hydroxy-4-cholesten-3-one (C4) and bile acids • Safety and tolerability;Primary end point(s): The primary efficacy endpoint is the change in ALP from baseline to Week 12 in the DB Phase. ;Timepoint(s) of evaluation of this end point: Baseline to Week 12	—

Measure

Time frame

Main Objective: The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase (ALP) in comparison to BZF alone in subjects with PBC;Secondary Objective: The secondary objectives are to assess the effects of the combination of OCA plus BZF versus BZF alone in subjects with PBC on the following: • Biochemical disease markers, including ALP, GGT, ALT, AST, total and conjugated bilirubin, and lipid panel • Biomarkers of bile acid synthesis and homeostasis, including 7a-hydroxy-4-cholesten-3-one (C4) and bile acids • Safety and tolerability;Primary end point(s): The primary efficacy endpoint is the change in ALP from baseline to Week 12 in the DB Phase. ;Timepoint(s) of evaluation of this end point: Baseline to Week 12

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Secondary

Measure	Time frame
Secondary end point(s): - Safety and tolerability - The response rates of >=10%, >=20%, >=30%, and >=40% reduction from baseline at Week 12, and normalization rates of ALP at Week 12 - Normalization rates at Week 12 of GGT, ALT, AST, total and conjugated bilirubin, and lipid panel - Change from baseline to Week 12 in GGT, ALT, AST, and total and conjugated bilirubin, and lipid panel - Change from baseline to Week 12 in 7a-hydroxy-4-cholesten-3-one (C4) and bile acids;Timepoint(s) of evaluation of this end point: Baseline to end of study	—

Measure

Time frame

Secondary end point(s): - Safety and tolerability - The response rates of >=10%, >=20%, >=30%, and >=40% reduction from baseline at Week 12, and normalization rates of ALP at Week 12 - Normalization rates at Week 12 of GGT, ALT, AST, total and conjugated bilirubin, and lipid panel - Change from baseline to Week 12 in GGT, ALT, AST, and total and conjugated bilirubin, and lipid panel - Change from baseline to Week 12 in 7a-hydroxy-4-cholesten-3-one (C4) and bile acids;Timepoint(s) of evaluation of this end point: Baseline to end of study

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Countries

Argentina, Canada, Italy, Turkey, United States

Contacts

Public ContactGlobal Regulatory Submissions

Labcorp Drug Development Limited

submissions@labcorp.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026