Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

Inclusion Criteria:

• Male or female participant who has a PBC diagnosis as demonstrated by the presenceof ≥2 of the following three diagnostic criteria:

• History of ALP above ULN for at least 6 months

• History of positive antimitochondrial antibody (AMA) titer or positivePBC-specific antinuclear antibody (ANA) titer

• Historical liver biopsy consistent with PBC

• Participant has the following qualifying biochemistry value at Screening:

• ALP ≥1.5 × ULN

• Participant is ≥18 years of age at consent.

• Participant meets all other eligibility criteria outlined in the Clinical StudyProtocol.

Exclusion Criteria:

• Participant meets any one of the following criteria at Screening:

• ALP>10 × ULN

• ALT or AST >5 × ULN

• Hepatitis C treatment within 5 years of Screening, or active hepatitis C asdefined by positive hepatitis C antibody with the presence of hepatitis C virusribonucleic acid; subjects with active hepatitis B (HBV) infection (hepatitis Bsurface antigen [HbsAg] positive) will be excluded. A subject with resolvedhepatitis A at least 3 months prior to the Screening Visit can be screened.

• Primary sclerosing cholangitis and secondary sclerosing cholangitis (eg, due tocholangiolithiasis, ischemia, telangiectasia, vasculitis, infectious diseases)

• Alcoholic liver disease

• History of definite autoimmune hepatitis or PBC/autoimmune hepatitis overlap,defined as both of the following: 1) IgG >2 × ULN and/or positive anti-smoothmuscle antibodies, 2) liver histology revealing moderate or severe periportalor periseptal inflammation

• Nonalcoholic steatohepatitis (NASH)

• Gilbert's Syndrome

• Alpha-1-antitrypsin deficiency, cystic fibrosis, Wilson's disease,hemochromatosis based on historically established diagnosis

• Drug-induced liver injury (DILI) as defined by typical exposure and history

• Known condition that involves bile duct obstruction or cholestasis other thanPBC, eg, vascular diseases (eg, Budd-Chiari syndrome, sinusoidal obstructionsyndrome, congestive hepatopathy), congenital conditions (ductal platemalformations, Caroli syndrome, congenital liver fibrosis), idiopathicductopenia

• Hepatocellular carcinoma

• Participant meets any other exclusion criteria outlined in the Clinical StudyProtocol.