A Phase 2 interventional study of Volixibat and Placebo in Primary Biliary Cholangitis and PBC, sponsored by Mirum Pharmaceuticals, Inc.. Active, not recruiting at 130 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Mirum Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's enrollment of 333 is above the median of 60 across 151 interventional studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Mirum Pharmaceuticals, Inc. is the lead sponsor of 40 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive volixibat 20mg twice daily.
Drug: Volixibat
Participants randomized to this arm will receive volixibat 80mg twice daily.
Drug: Volixibat
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Drug: Placebo
Participants randomized to this arm will receive volixibat 20mg twice daily.
Drug: Volixibat
Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.
Drug: Placebo
Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.
Also known as: SHP626
Capsules matched to study drug without the active pharmaceutical ingredient
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire
The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.
Time frame: Baseline to week 28
Proportion of participants with itch response using the Adult ItchRO
Time frame: Baseline to week 28
Incidence of adverse events
Time frame: Baseline to week 28
Changes in alkaline phosphatase
Time frame: Baseline to week 28
Changes in total bilirubin
Time frame: Baseline to week 28
Changes in serum bile acid levels
Time frame: Baseline to week 28
Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40)
PBC-40 questionnaire is scored on a scale of 40 to 200, with higher scores indicating poorer quality of life
Time frame: Baseline to week 28
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue questionnaire
The PROMIS® Fatigue questionnaire is a 5-point response scale. Respondents endorse each item using a 5-point response scale: Never, Rarely, Sometimes, Often, and Always.
Time frame: Baseline to week 28
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance questionnaire
The PROMIS® Sleep Disturbance in an 8-item measure that assesses quality of sleep, sleep depth, and restoration associated with sleep. It is a 5-point response scale, the specific response options vary by items. The first 4 items use response options that range from Not at all to Very much. The next 3 items use response options that range from Never to Always. The final item assesses sleep quality ranging from Very poor to Very good.
Time frame: Baseline to week 28
Showing the first 100 of 130 sites across 15 countries. Choose a country and city above to see the rest.
Started Sep 2021 (actual). Primary completion is estimated for Jan 2027, 64 months after the start.
Of 21 phase 2 interventional studies under Liver Cirrhosis, Biliary, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 34. This study's planned 64 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Volixibat