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New pill aims to stop the relentless itch of a rare liver disease

NCT ID NCT05050136

Symptom relief Sponsor: Mirum Pharmaceuticals, Inc. 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This study tests an experimental drug called volixibat for people with primary biliary cholangitis (PBC) who suffer from severe itching. The trial will involve 260 adults and compare volixibat against a placebo to see if it safely reduces itch severity and improves quality of life. It is a Phase 2 study, meaning it is still early and results are not yet confirmed.

What this could mean

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

Active substance
volixibat
What this could lead to
If it works, this could offer a new way to relieve severe itching in people with primary biliary cholangitis, improving daily comfort and quality of life.
What could go wrong
This is an early Phase 2 trial, so results are not yet proven. The drug may not reduce itching better than placebo, and side effects are still being studied.

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

333 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Dec 2028

An estimate. End dates often move.

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: * Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study * Male or female, age ≥18 years at the screening visit * Confirmed diagnosis of PBC in line with the AASLD guidelines * UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria * Qualified pruritus associated with PBC as assessed by Adult ItchRO Exclusion Criteria: * Pruritus associated with an etiology other than PBC * Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events * Current symptomatic cholelithiasis or inflammatory gallbladder disease * History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation. * Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded * History of Liver transplantation

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Conditions

The condition(s) this trial relates to.

cholangitis Digestive System Diseases primary biliary cholangitis primary biliary cholangitis 1 Pruritus

As listed by the trial registrant

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

PBC Primary biliary cholangitis

Contacts and locations

Locations

  • (G.I.R.I.) GI Research Institute Foundation

    Vancouver, British Columbia, V6Z 2K5, Canada

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • ASST Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Advanced Research Institute, Inc

    New Port Richey, Florida, 34653, United States

  • Amel Med LLC

    Austin, Texas, 78750, United States

  • Amstedam University Medical Centers

    Amsterdam, 1081 HV, Netherlands

  • Azienda Ospedale-Università di Padova

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127, Italy

  • Azienda Ospedaliero Universitaria Di Modena

    Modena, 41126, Italy

  • Azienda Ospedaliero Universitaria Pisana (AOUP)

    Pisa, 56124, Italy

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 10050, China

  • Beijing Youan Hospital, Capital Medical University

    Beijing, 100069, China

  • Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital

    Belfast, BT12 6BA, United Kingdom

  • Beth Israel Deaconess

    Boston, Massachusetts, 02215, United States

  • Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital

    Newport News, Virginia, 23602, United States

  • Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226, United States

  • CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan

    Omaha, Nebraska, 68124, United States

  • CHU Grenoble - Hôpital MICHALLON

    Grenoble, 38043, France

  • CHU de NICE- Hospital L'Archet 2

    Nice, 06202, France

  • CRCHUM (Centre de Recherche du Centre Hospitalier de l'Université de Montréal)

    Montreal, H2X 0A9, Canada

  • Carmel Medical Center

    Haifa, 3434104, Israel

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centro de Pesquisa Clínica da Bahiana Saúde

    Salvador, Estado de Bahia, 40290-000, Brazil

  • Centro de Pesquisas Clínicas do HC/UFMG-EBSERH

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

    Santa Fe, 3000, Argentina

  • Covenant Metabolic Specialists

    Fort Myers, Florida, 33912, United States

  • Covenant Research and Clinics, LLC

    Sarasota, Florida, 34240, United States

  • Ehime University Hospital

    Ehime, 791-0295, Japan

  • Einstein Healthcare Network - Einstein Medical Center

    Philadelphia, Pennsylvania, 19141, United States

  • Ente Ospedaliero Cantonale

    Lugano, 6900, Switzerland

  • Erasmus medical center

    Rotterdam, Netherlands

  • Fondazione Ca Granda

    Milan, 20122, Italy

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900, Italy

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Fundação Oswaldo Ramos

    São Paulo, 04038-002, Brazil

  • Galen Medical Group, P.C

    Tennessee City, Tennessee, 37343, United States

  • Galilee Medical Center

    Nahariya, 2210001, Israel

  • Glenny Corp S.A

    CABA, 1430, Argentina

  • Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000

    Jerusalem, 9112001, Israel

  • Hillel Yaffe Medical Center

    Hadera, 3810101, Israel

  • Hopital Claude Huriez-Digestive system disease clinic

    Lille, 59037, France

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Das Clínicas Da Ufg

    Goiânia, Goiás, 74605-050, Brazil

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Paul Brousse- APHP

    Villejuif, 94800, France

  • Hospital Provincial Del Centenario

    Rosario, Santa Fe Province, 2000, Argentina

  • Hospital Saint Antoine

    Paris, 75012, France

  • Hospital Universitari Parc Tauli

    Barcelona, 08208, Spain

  • Hospital Universitari Vall d' Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitário Clementino Fraga Filho - Secretaria de Hepatologia

    Rio de Janeiro, 21941-617, Brazil

  • Hospital de Alta Complejidad En Red El Cruce

    San Juan Bautista, Buenos Aires, 1888, Argentina

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035903, Brazil

  • IHS Health

    Kissimmee, Florida, 34741, United States

  • Impact Research

    Waco, Texas, 76710, United States

  • Instituto de Educação, Pesquisa e Gestão em Saúde

    Rio de Janeiro, 22775-001, Brazil

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Jackson Liver and GI Specialists

    Jackson, Mississippi, 39216, United States

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116, Germany

  • LSU Health Science Center Shreveport

    Shreveport, Louisiana, 71103, United States

  • Liver Associates of Texas

    Houston, Texas, 77030, United States

  • Liver Institute Northwest

    Seattle, Washington, 98105, United States

  • Loyola University Health System - Loyola Outpatient Center

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • McMaster University Medical Center

    Hamilton, Ontario, L8S 4K1, Canada

  • MedStar Health Research Institute

    Fairfax, Virginia, 22031, United States

  • Medizinische Hochschule Hannover (MHH)

    Hanover, 30625, Germany

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028, China

  • Methodist Le Bonheur Healthcare

    Memphis, Tennessee, 38104, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • National Hospital Organization Nagasaki Medical Center

    Ōmura, Nagasaki, 856-8562, Japan

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Nottingham University Hospitals NHS Trust

    Nottingham, United Kingdom

  • Nouvel Hospital Civil

    Strasbourg, 67091, France

  • Ochsner Clinic Foundation-Baton Rouge

    Baton Rouge, Louisiana, 70836, United States

  • Osaka Rosai Hospital

    Osaka, 591-8025, Japan

  • Otto-von-Guericke-Universität Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Magdeburg A.ö.R.

    Magdeburg, 39120, Germany

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Radboudumc

    Nijmegen, 6525 GA, Netherlands

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Royal Free Hospital NHS Foundation Trust

    London, NW3 2QZ, United Kingdom

  • Schiff Center for Liver Diseases

    Miami, Florida, 33136, United States

  • Science 37, Inc (Remote-homebased Telemedicine)

    Morrisville, North Carolina, 27560, United States

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Sir Run Run Shaw Hospital -Zhejiang University School of Medicine

    Hangzhou, 310009, China

  • Soma Clinical Trials

    Denison, Texas, 75020, United States

  • Southeast Clinical Research Center

    Dalton, Georgia, 30720, United States

  • Southern California Research Center

    Coronado, California, 92218, United States

  • St. Josefs-Hospital Wiesbaden

    Wiesbaden, 65189, Germany

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Teine Keijinkai Hospital

    Hokkaido, 006-8555, Japan

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130031, China

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Toranomon Hospital

    Tokyo, 105-8470, Japan

  • Toronto General Hospital

    Toronto, Ontario, M5G 1Z5, Canada

  • UC Davis

    Sacramento, California, 95817, United States

  • UF Health Gastroenterology- Emerson

    Jacksonville, Florida, 32209, United States

  • UF Hepatology Research at CTRB

    Gainesville, Florida, 32610, United States

  • UZ Gent

    Ghent, 9000, Belgium

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Universita Politecnica delle Marche- Ospedali Riuniti

    Ancona, Italy

  • Universitair Ziekenhuis Antwerpe UZA

    Antwerp, 2650, Belgium

  • University Hospital Munster

    Münster, 48149, Germany

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, S016 6YD, United Kingdom

  • University Hospital Tübingen Medical clinic

    Tübingen, 72076, Germany

  • University Hospital Zurich(USZ)

    Zurich, 8091, Switzerland

  • University Hospital, LHSC

    London, Ontario, N6A5A5, Canada

  • University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters

    Birmingham, West Midlands, B15 2GW, United Kingdom

  • University of Alberta

    Edmonton, T6G 2X8, Canada

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

  • University of Utah Health Care

    Salt Lake City, Utah, 84132, United States

  • Universitätsklinikum Frankfurt am Main

    Frankfurt, Germany

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie

    Leipzig, 04103, Germany

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105, Germany

  • Virtua Center for Liver Disease-Camden

    Camden, New Jersey, 08103, United States

  • Yale University Digestive Diseases

    New Haven, Connecticut, 06510, United States

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