Mirum VLX-601 PBC

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