To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

NCT06488911 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 977-311
• Study Type: interventional
• Target: 62
• Locations: 20 countries
• Sites: 50

Brief Summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).

Conditions

Primary Biliary Cholangitis

Keywords

Primary Biliary Cholangitis; Obeticholic Acid; Bezafibrate; Ursodeoxycholic acid

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation

  A TEAE was defined as any event not present before the initiation of the investigational product in this study or any event already present, which worsened in either severity or frequency following exposure to the investigational product in this study. A serious TEAE was defined as any untoward medical occurrence that at any dose resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality or birth defect, an important medical event that may jeopardize the participant or may require medical intervention.

  Early Termination (Up to Month 12)

• Number of Participants Reporting Severe TEAEs

  A severe (Grade 3) TEAE is defined as an AE that causes inability to carry out usual activities; the subject may experience intolerable discomfort or pain.

  Early Termination (Up to Month 12)

Secondary Outcomes (3)

• Number of Participants Reporting All-Cause Mortality

  Early Termination (Up to Month 12)

• Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters

  Early Termination (Up to Month 12)

• Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters

  Early Termination (Up to Month 12)

Study Arms (1)

OCA 5 mg + BZF 400 mg SR

EXPERIMENTAL

Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily.

Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR)

Interventions

FDC tablet (OCA 5 mg + BZF 400 mg SR) DRUG

Participants will be administered with FDC tablets once daily.

OCA 5 mg + BZF 400 mg SR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311).

You may not qualify if:

• History or presence of other concomitant liver diseases
• Clinical complications of PBC
• History or presence of hepatic 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.

Sponsors & Collaborators

• Intercept Pharmaceuticals: lead

Study Sites (51)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Southern California Research Center

Coronado, California, 92118, United States

Location

Tampa General Medical Group

Tampa, Florida, 33606, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

East Tennessee Research Institute

Johnson City, Tennessee, 37604, United States

Location

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

American Research Corporation

San Antonio, Texas, 78215, United States

Location

DIM Clinica Privada

Buenos Aires, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Hospital Italiano de La Plata

Buenos Aires, Argentina

Location

Hospital Universitario Austral

Buenos Aires, Argentina

Location

Hospital Provincial del Centenario

Santa Fe, Argentina

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, 5042, Australia

Location

UZ Leuven

Leuven, 3000, Belgium

Location

University of Alberta Division of Gastroenterology Zeidler Ledcor Centre

Edmonton, Alberta, Canada

Location

Pacific Gastroenterology Associates GI Research Institute

Vancouver, British Columbia, Canada

Location

Universityl Hospital Dubrava

Zagreb, 10 000, Croatia

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 50012, Czechia

Location

Artroscan s.r.o. Gastroenterologicka

Ostrava, 722100, Czechia

Location

Research Site SRO

Pilsen, 30100, Czechia

Location

Tartu University Hospital

Tartu, 50090, Estonia

Location

Hopital Henri Mondor

Créteil, 94000, France

Location

CHRU de Lille

Lille, 59000, France

Location

CHU Paris Est - Hopital Saint Antoine

Paris, 75012, France

Location

Hopital de la Pitie Salpetriere

Paris, 75013, France

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

University Hospital of Larissa

Larissa, 41110, Greece

Location

DEOEC II. sz. Belgygyszati Klinika

Debrecen, 4032, Hungary

Location

Hadassah Ein-Karem Medical Center - Liver unit

Jerusalem, 9112001, Israel

Location

Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

Bologna, Italy

Location

University Hopital Santaros klinikos

Vilnius, 8661, Lithuania

Location

Academisch Medisch Centrum

Amsterdam, 1005 AZ, Netherlands

Location

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Hospital ClinicUniversity of Barcelona

Barcelona, 8036, Spain

Location

Consorcio Hospital General Universitario

Valencia, 46014, Spain

Location

Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology

Ankara, Turkey (Türkiye)

Location

Ege University, Faculty of Medicine, Gastroenterology

Bornova, Turkey (Türkiye)

Location

Istanbul University, Capa Faculty of Medicine, Gastroenterology

Istanbul, Turkey (Türkiye)

Location

Harran University Hospital, Gastroenterology

Sanliurfa, Turkey (Türkiye)

Location

Hull University Teaching Hospitals NHS Trust

Hull, HU32JZ, United Kingdom

Location

Institute of Cellular Medicine Newcastle University

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The Sponsor 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.

Results Point of Contact

• Title: Medical Information
• Organization: Intercept Pharmaceuticals, Inc.

medinfo@interceptpharma.com

844-782-4278

Study Officials

• Lynda Szczech, PhD

  Intercept Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2024
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: June 8, 2026
• Results First Posted: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); AU (2); HU (1); CA (2); FR (4); TU (4); CZ (3); US (13); NO (1); CR (1); KR (2); ES (2); GB (3); LI (1); AR (5); GR (1); IT (1); DE (1); BE (1); IL (1)