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New combo therapy aimed at Hard-to-Treat liver disease

NCT ID NCT04594694

Disease control Sponsor: Intercept Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tested whether combining two drugs, obeticholic acid and bezafibrate, could improve liver health in people with primary biliary cholangitis (PBC) who did not respond well to or could not take the standard medicine. The trial enrolled 75 adults and measured changes in a key liver enzyme over 12 weeks. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

75 people

The number who actually took part.

Started

Oct 2019

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 * Treatment with commercially available OCA or other farnesoid X receptor (FXR) agonists, or participation in a previous study involving OCA within 3 months before Screening. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Fibrosis primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary biliary cholangitis

Contacts and locations

Locations

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ, Netherlands

  • Artroscan s.r.o., Gastroenterologicka ambulance

    Ostrava, 722 00, Czechia

  • Budai Hepatologiai Centrum (BHC)

    Budapest, 1111, Hungary

  • CHRU de Lille

    Lille, 59000, France

  • CHU Paris Est - Hopital Saint Antoine

    Paris, Paris 12, France

  • Centre Hospitalier Universitaire Grenoble

    Grenoble, 38043, France

  • Clinical Hospital Dubrava

    Zagreb, 10000, Croatia

  • Consorcio Hospital General Universitario

    Valencia, 46010, Spain

  • DEOEC II. sz. Belgyógyászati Klinika

    Debrecen, 4032, Hungary

  • Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa

    Larissa, 41110, Greece

  • Flinders Medical Centre

    Bedford Park, Perth, 5042, Australia

  • Fundacio Clinic Per La Recerca Biomedica

    Barcelona, 08036, Spain

  • Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris

    Paris, 75651, France

  • Hadassah Ein-Karem Medical Center - Liver unit

    Jerusalem, 91120, Israel

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12, Czechia

  • Hospital of Lithuanian University of Health Sciences, Kauno Klinikos

    Kaunas, 50161, Lithuania

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ, United Kingdom

  • Hôpital Henri Mondor

    Créteil, 940000, France

  • Institute of Cellular Medicine, Newcastle University

    Newcastle upon Tyne, NE2 4HH, United Kingdom

  • John Radcliffe Hospital

    Oxford, OX3 9DU, United Kingdom

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej

    Warsaw, 02-781, Poland

  • Pusan National University Hospital

    Busan, 602-739, South Korea

  • Research Site s.r.o.

    Pilsen, 301 00, Czechia

  • Royal Adelaide Hospital

    Adelaide, 5000, Australia

  • Tartu University Hospital

    Tartu, 51014, Estonia

  • Tel Aviv Surasky Medical Center

    Tel Aviv, 6423906, Israel

  • UZ Gasthuisberg

    Leuven, 3000, Belgium

  • Universitatsklinikum Hamburg-Eppendorf UKE

    Hamburg, 20246, Germany

  • Universitetet i Oslo - Akershus Universitetssykehus (AHUS)

    Loerenskog, 1478, Norway

  • Vlinius University

    Vilnius, 08661, Lithuania

  • Zagreb University Hospital Center

    Zagreb, 10000, Croatia

More trials for these conditions

Other studies related to the condition(s) this trial covers.