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New drug cocktail aims to tame rare liver disease

NCT ID NCT05239468

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study tested whether adding bezafibrate to the standard drug obeticholic acid helps people with primary biliary cholangitis, a rare liver disease. 72 adults took part, and researchers measured changes in a key liver enzyme over 12 weeks. The goal is to see if the combination works better than either drug alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bezafibrate and obeticholic acid
What this could lead to
If it works, this combination could offer a new way to control primary biliary cholangitis and improve liver health.
What could go wrong
This is an early Phase 2a trial with only 72 people. It may not show clear benefit, and side effects like gallbladder problems are possible.

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

72 people

The number who actually took part.

Started

Mar 2022

Finished

Sep 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 * Presence of clinical complications of PBC * History or presence of 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 participation in a previous study involving OCA, or other farnesoid X receptor (FXR) agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening * Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates, or participation in a previous study involving fibrate 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

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215, United States

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

    Bologna, Italy

  • Beth Israel Deaconess Medical Center Harvard Liver Research Center

    Boston, Massachusetts, 02215, United States

  • DIM Clinical Privada

    Ramos Mejía, Buenos Aires, Argentina

  • Facey Medical Group

    Mission Hills, California, 91345, United States

  • Gastro One

    Cordova, Tennessee, 38018, United States

  • Gastrointestinal Associates of Northeast Tennessee

    Johnson City, Tennessee, 37604, United States

  • Hospital Italiano La Plata

    La Plata, Buenos Aires, Argentina

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Argentina

  • Hospital Provincial del Centenario

    Rosario, Argentina

  • Hospital Universitario Austral

    Pilar, Argentina

  • Houston Methodist Cancer Center

    Houston, Texas, 77030-2717, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60459, United States

  • Methodist Clinical Research Institute (CRI)

    Dallas, Texas, 75203, United States

  • NYU Langone Medical Center

    New York, New York, 10016-6402, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Pacific Gastroenterology Associates

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309, United States

  • Schiff Center for Liver Diseases / University of Miami

    Miami, Florida, 33136, United States

  • Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado

    Coronado, California, 92118, United States

  • Tampa General Medical Group

    Tampa, Florida, 33606, United States

  • The Northern Alberta Clinical Trials and Research Centre

    Edmonton, Alberta, T6G 287, Canada

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Montreal

    Montreal, Quebec, Canada

  • Wake Endoscopy Center

    Raleigh, North Carolina, 27607, United States

More trials for these conditions

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