Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis

Inclusion Criteria:

• Must have provided written informed consent;

• Age 18-75 years;

• BMI 17-28 kg/m2

• Male or female with a diagnosis of PBC, by at least two of the following criteria:

• History of AP above ULN for at least six months;

• Positive AMA titers (>1/40 on immunofluorescence or M2 positive by enzymelinked immunosorbent assay (ELISA) or positive PBC-specific antinuclearantibodies;

• Documented liver biopsy result consistent with PBC.

• Incomplete response to UDCA defined by Xi'an criteria (ALP >2.5× ULN, AST>2×ULN orTBIL>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test inALP or TBIL.

Exclusion Criteria:

• History or presence of other concomitant liver diseases.

• ALT/AST > 5×ULN, TBIL > 3×ULN.

• If female: known pregnancy, or has a positive urine pregnancy test (confirmed by apositive serum pregnancy test), or lactating.

• Allergic to fenofibrate or ursodeoxycholic acid.

• Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole,rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.

• Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractoryascites.

• Patients with a history of severe cardiac, cerebrovascular, renal, respiratorydisease or functional failure, and psychiatric disorders (including those due toalcohol and drug abuse).

• Creatinine >1.5×ULN and creatinine clearance <60 ml/min.

• Currently using statins (such as pravastatin, fluvastatin, and simvastatin), otherfibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar tofenofibrate (like ketoprofen).

• Planned to receive an organ transplant or an organ transplant recipient.

• Needing Liver transplantation within 1 year according to the Mayo Rick score.

• Any other condition(s) that would compromise the safety of the subject or compromisethe quality of the clinical study, as judged by the Investigator.