['primary biliary cholangitis (pbc)']
['elafibranor 80 mg', 'elafibranor 120 mg', 'placebo']

        Inclusion Criteria:

          1. Must have provided written informed consent

          2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of
             the following 3 diagnostic factors:

               -  History of elevated ALP levels for at least 6 months prior to Day 0
                  (randomization visit)

               -  Positive Anti-Mitochondrial Antibodies (AMA) titers (> 1/40 on immunofluorescence
                  or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive
                  PBC-specific antinuclear antibodies

               -  Liver biopsy consistent with PBC

          3. ALP >= 1.67x upper limit of normal (ULN)

          4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening
             visit

          5. Contraception: Females participating in this study must be of non-childbearing
             potential or must be using highly efficient contraception for the full duration of the
             study and for 1 month after the end of treatment.

        Exclusion Criteria:

          1. History or presence of other concomitant liver diseases

          2. Screening creatine phosphokinase (CPK) > upper limits of normal (ULN)

          3. Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) > 5 ULN

          4. Screening total bilirubin > 2 ULN

          5. Screening serum creatinine > 1.5 mg/dl

          6. Significant renal disease, including nephritic syndrome, chronic kidney disease
             (defined as patients with markers of kidney damage or estimated glomerular filtration
             rate [eGFR] of less than 60 mL/min/1.73 m^2).

          7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)

          8. Platelet count <150 X 10^3/microliter

          9. Albumin <3.5 g/dL

         10. Presence of clinical complications of PBC or clinically significant hepatic
             decompensation

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

         12. Known history of human immunodeficiency virus (HIV) infection

         13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
      