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

NCT ID NCT05050136

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

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

    RECRUITING

    Vancouver, British Columbia, V6Z 2K5, Canada

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, 24127, Italy

  • Advanced Research Institute, Inc

    RECRUITING

    New Port Richey, Florida, 34653, United States

  • Amel Med LLC

    TERMINATED

    Austin, Texas, 78750, United States

  • Amstedam University Medical Centers

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • Azienda Ospedale-Università di Padova

    RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    RECRUITING

    Palermo, 90127, Italy

  • Azienda Ospedaliero Universitaria Di Modena

    RECRUITING

    Modena, 41126, Italy

  • Azienda Ospedaliero Universitaria Pisana (AOUP)

    RECRUITING

    Pisa, 56124, Italy

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, 10050, China

  • Beijing Youan Hospital, Capital Medical University

    RECRUITING

    Beijing, 100069, China

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

    RECRUITING

    Belfast, BT12 6BA, United Kingdom

  • Beth Israel Deaconess

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital

    TERMINATED

    Newport News, Virginia, 23602, United States

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

    RECRUITING

    Richmond, Virginia, 23226, United States

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

    RECRUITING

    Omaha, Nebraska, 68124, United States

  • CHU Grenoble - Hôpital MICHALLON

    RECRUITING

    Grenoble, 38043, France

  • CHU de NICE- Hospital L'Archet 2

    RECRUITING

    Nice, 06202, France

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

    RECRUITING

    Montreal, H2X 0A9, Canada

  • Carmel Medical Center

    RECRUITING

    Haifa, 3434104, Israel

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centro de Pesquisa Clínica da Bahiana Saúde

    RECRUITING

    Salvador, Estado de Bahia, 40290-000, Brazil

  • Centro de Pesquisas Clínicas do HC/UFMG-EBSERH

    RECRUITING

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Cleveland Clinic - Main Campus

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

    RECRUITING

    Santa Fe, 3000, Argentina

  • Covenant Metabolic Specialists

    TERMINATED

    Fort Myers, Florida, 33912, United States

  • Covenant Research and Clinics, LLC

    TERMINATED

    Sarasota, Florida, 34240, United States

  • Ehime University Hospital

    RECRUITING

    Ehime, 791-0295, Japan

  • Einstein Healthcare Network - Einstein Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19141, United States

  • Ente Ospedaliero Cantonale

    RECRUITING

    Lugano, 6900, Switzerland

  • Erasmus medical center

    RECRUITING

    Rotterdam, Netherlands

  • Fondazione Ca Granda

    TERMINATED

    Milan, 20122, Italy

  • Fondazione IRCCS San Gerardo dei Tintori

    RECRUITING

    Monza, 20900, Italy

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Fundação Oswaldo Ramos

    RECRUITING

    São Paulo, 04038-002, Brazil

  • Galen Medical Group, P.C

    RECRUITING

    Tennessee City, Tennessee, 37343, United States

  • Galilee Medical Center

    RECRUITING

    Nahariya, 2210001, Israel

  • Glenny Corp S.A

    RECRUITING

    CABA, 1430, Argentina

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

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

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

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hillel Yaffe Medical Center

    TERMINATED

    Hadera, 3810101, Israel

  • Hopital Claude Huriez-Digestive system disease clinic

    RECRUITING

    Lille, 59037, France

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Das Clínicas Da Ufg

    RECRUITING

    Goiânia, Goiás, 74605-050, Brazil

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Paul Brousse- APHP

    RECRUITING

    Villejuif, 94800, France

  • Hospital Provincial Del Centenario

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

  • Hospital Saint Antoine

    RECRUITING

    Paris, 75012, France

  • Hospital Universitari Parc Tauli

    RECRUITING

    Barcelona, 08208, Spain

  • Hospital Universitari Vall d' Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitário Clementino Fraga Filho - Secretaria de Hepatologia

    RECRUITING

    Rio de Janeiro, 21941-617, Brazil

  • Hospital de Alta Complejidad En Red El Cruce

    RECRUITING

    San Juan Bautista, Buenos Aires, 1888, Argentina

  • Hospital de Clínicas de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035903, Brazil

  • IHS Health

    TERMINATED

    Kissimmee, Florida, 34741, United States

  • Impact Research

    TERMINATED

    Waco, Texas, 76710, United States

  • Instituto de Educação, Pesquisa e Gestão em Saúde

    RECRUITING

    Rio de Janeiro, 22775-001, Brazil

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Italy

  • Jackson Liver and GI Specialists

    TERMINATED

    Jackson, Mississippi, 39216, United States

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Klinikum Chemnitz gGmbH

    RECRUITING

    Chemnitz, 09116, Germany

  • LSU Health Science Center Shreveport

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Liver Associates of Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • Liver Institute Northwest

    RECRUITING

    Seattle, Washington, 98105, United States

  • Loyola University Health System - Loyola Outpatient Center

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • McMaster University Medical Center

    RECRUITING

    Hamilton, Ontario, L8S 4K1, Canada

  • MedStar Health Research Institute

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Medizinische Hochschule Hannover (MHH)

    RECRUITING

    Hanover, 30625, Germany

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, 350028, China

  • Methodist Le Bonheur Healthcare

    TERMINATED

    Memphis, Tennessee, 38104, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • National Hospital Organization Nagasaki Medical Center

    RECRUITING

    Ōmura, Nagasaki, 856-8562, Japan

  • Northwestern University

    TERMINATED

    Chicago, Illinois, 60611, United States

  • Nottingham University Hospitals NHS Trust

    RECRUITING

    Nottingham, United Kingdom

  • Nouvel Hospital Civil

    RECRUITING

    Strasbourg, 67091, France

  • Ochsner Clinic Foundation-Baton Rouge

    RECRUITING

    Baton Rouge, Louisiana, 70836, United States

  • Osaka Rosai Hospital

    RECRUITING

    Osaka, 591-8025, Japan

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

    RECRUITING

    Magdeburg, 39120, Germany

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Radboudumc

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Rambam Medical Center

    RECRUITING

    Haifa, 3109601, Israel

  • Royal Free Hospital NHS Foundation Trust

    RECRUITING

    London, NW3 2QZ, United Kingdom

  • Schiff Center for Liver Diseases

    TERMINATED

    Miami, Florida, 33136, United States

  • Science 37, Inc (Remote-homebased Telemedicine)

    RECRUITING

    Morrisville, North Carolina, 27560, United States

  • Shaare Zedek Medical Center

    TERMINATED

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 52621, Israel

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

    RECRUITING

    Hangzhou, 310009, China

  • Soma Clinical Trials

    TERMINATED

    Denison, Texas, 75020, United States

  • Southeast Clinical Research Center

    TERMINATED

    Dalton, Georgia, 30720, United States

  • Southern California Research Center

    TERMINATED

    Coronado, California, 92218, United States

  • St. Josefs-Hospital Wiesbaden

    ACTIVE_NOT_RECRUITING

    Wiesbaden, 65189, Germany

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • Teine Keijinkai Hospital

    RECRUITING

    Hokkaido, 006-8555, Japan

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130031, China

  • The Liver Institute at Methodist Dallas Medical Center

    RECRUITING

    Dallas, Texas, 75203, United States

  • The Tel Aviv Sourasky Medical Center

    TERMINATED

    Tel Aviv, 6423906, Israel

  • Toranomon Hospital

    RECRUITING

    Tokyo, 105-8470, Japan

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 1Z5, Canada

  • UC Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • UF Health Gastroenterology- Emerson

    TERMINATED

    Jacksonville, Florida, 32209, United States

  • UF Hepatology Research at CTRB

    RECRUITING

    Gainesville, Florida, 32610, United States

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

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

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Universita Politecnica delle Marche- Ospedali Riuniti

    RECRUITING

    Ancona, Italy

  • Universitair Ziekenhuis Antwerpe UZA

    RECRUITING

    Antwerp, 2650, Belgium

  • University Hospital Munster

    RECRUITING

    Münster, 48149, Germany

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, Hampshire, S016 6YD, United Kingdom

  • University Hospital Tübingen Medical clinic

    RECRUITING

    Tübingen, 72076, Germany

  • University Hospital Zurich(USZ)

    RECRUITING

    Zurich, 8091, Switzerland

  • University Hospital, LHSC

    RECRUITING

    London, Ontario, N6A5A5, Canada

  • University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters

    RECRUITING

    Birmingham, West Midlands, B15 2GW, United Kingdom

  • University of Alberta

    RECRUITING

    Edmonton, T6G 2X8, Canada

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospitals & Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Utah Health Care

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Universitätsklinikum Frankfurt am Main

    RECRUITING

    Frankfurt, Germany

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

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Schleswig-Holstein

    RECRUITING

    Kiel, 24105, Germany

  • Virtua Center for Liver Disease-Camden

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Yale University Digestive Diseases

    RECRUITING

    New Haven, Connecticut, 06510, United States

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