Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

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 CPK > ULN

3. Screening ALT or 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 m2).

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)