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A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
NCT05050136 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Volixibat
Study Locations (20)
Florida
- Covenant Metabolic Specialists — Fort Myers
- UF Hepatology Research at CTRB — Gainesville
- UF Health Gastroenterology- Emerson — Jacksonville
- IHS Health — Kissimmee
- Schiff Center for Liver Diseases — Miami
- Advanced Research Institute, Inc — New Port Richey
- Covenant Research and Clinics, LLC — Sarasota
- Tampa General Hospital — Tampa
- Cleveland Clinic Florida — Weston
California
- Southern California Research Center — Coronado
- Cedars Sinai Medical Center — Los Angeles
- UC Davis — Sacramento
Illinois
- Northwestern University — Chicago
- Loyola University Health System - Loyola Outpatient Center — Maywood
Louisiana
- Ochsner Clinic Foundation-Baton Rouge — Baton Rouge
- LSU Health Science Center Shreveport — Shreveport
Colorado
- University of Colorado — Aurora
Connecticut
- Yale University Digestive Diseases — New Haven
Georgia
- Southeast Clinical Research Center — Dalton
Iowa
- University of Iowa Hospitals & Clinics — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2021-09-22 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05050136
The ClinicalTrials.gov registry entry for NCT05050136 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mirum Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05050136 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05050136 about?
NCT05050136 is a clinical study titled "A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis". The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
What is the current status of trial NCT05050136?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2021-09-22. Estimated completion is 2027-07.
What conditions does trial NCT05050136 study?
This clinical trial studies the following conditions: Primary Biliary Cholangitis, PBC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05050136?
The interventions under investigation include: Placebo (DRUG), Volixibat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05050136?
This trial is sponsored by Mirum Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05050136 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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