A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

ClinicalTrials.gov ID: NCT05050136

Public ClinicalTrials.gov record NCT05050136. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 19, 2026, 9:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis

Study identification

NCT ID: NCT05050136
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Mirum Pharmaceuticals, Inc.; Industry
Enrollment: 260 participants

Conditions and interventions

Conditions

Interventions

Placebo Drug
Volixibat Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 21, 2021
Primary completion: Mar 31, 2027
Completion: Jun 30, 2027
Last update posted: May 13, 2026

2021 – 2027

United States locations

U.S. sites: 44
U.S. states: 22
U.S. cities: 41

Facility	City	State	ZIP	Site status
Southern California Research Center	Coronado	California	92218	Terminated
Cedars Sinai Medical Center	Los Angeles	California	90048	Recruiting
University of California Los Angeles	Los Angeles	California	90095	Recruiting
UC Davis	Sacramento	California	95817	Recruiting
University of Colorado	Aurora	Colorado	80045	Recruiting
Yale University Digestive Diseases	New Haven	Connecticut	06510	Recruiting
Covenant Metabolic Specialists	Fort Myers	Florida	33912	Terminated
UF Hepatology Research at CTRB	Gainesville	Florida	32610	Recruiting
UF Health Gastroenterology- Emerson	Jacksonville	Florida	32209	Terminated
IHS Health	Kissimmee	Florida	34741	Terminated
Schiff Center for Liver Diseases	Miami	Florida	33136	Terminated
Advanced Research Institute, Inc	New Port Richey	Florida	34653	Recruiting
Covenant Research and Clinics, LLC	Sarasota	Florida	34240	Terminated
Tampa General Hospital	Tampa	Florida	33606	Recruiting
Cleveland Clinic Florida	Weston	Florida	33331	Recruiting
Southeast Clinical Research Center	Dalton	Georgia	30720	Terminated
Northwestern University	Chicago	Illinois	60611	Terminated
Loyola University Health System - Loyola Outpatient Center	Maywood	Illinois	60153	Recruiting
University of Iowa Hospitals & Clinics	Iowa City	Iowa	52242	Recruiting
Ochsner Clinic Foundation-Baton Rouge	Baton Rouge	Louisiana	70836	Recruiting
LSU Health Science Center Shreveport	Shreveport	Louisiana	71103	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Beth Israel Deaconess	Boston	Massachusetts	02215	Recruiting
Mayo Clinic	Rochester	Minnesota	55905	Recruiting
Jackson Liver and GI Specialists	Jackson	Mississippi	39216	Terminated
CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan	Omaha	Nebraska	68124	Recruiting
Virtua Center for Liver Disease-Camden	Camden	New Jersey	08103	Recruiting
Montefiore Medical Center	The Bronx	New York	10467	Recruiting
Science 37, Inc (Remote-homebased Telemedicine)	Morrisville	North Carolina	27560	Recruiting
Cleveland Clinic - Main Campus	Cleveland	Ohio	44195	Recruiting
Einstein Healthcare Network - Einstein Medical Center	Philadelphia	Pennsylvania	19141	Recruiting
Methodist Le Bonheur Healthcare	Memphis	Tennessee	38104	Terminated
Galen Medical Group, P.C	Tennessee City	Tennessee	37343	Recruiting
Amel Med LLC	Austin	Texas	78750	Terminated
The Liver Institute at Methodist Dallas Medical Center	Dallas	Texas	75203	Recruiting
Soma Clinical Trials	Denison	Texas	75020	Terminated
Baylor College of Medicine	Houston	Texas	77030	Recruiting
Liver Associates of Texas	Houston	Texas	77030	Recruiting
Impact Research	Waco	Texas	76710	Terminated
University of Utah Health Care	Salt Lake City	Utah	84132	Recruiting
MedStar Health Research Institute	Fairfax	Virginia	22031	Recruiting
Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital	Newport News	Virginia	23602	Terminated
Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond	Richmond	Virginia	23226	Recruiting
Liver Institute Northwest	Seattle	Washington	98105	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 86 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05050136, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 13, 2026 · Synced May 19, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05050136 live on ClinicalTrials.gov.

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