A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS )

• Males or females, between 18 and 75 years of age, inclusive.

• a) Patients on therapeutic doses of Ursodeoxycholic acid (UDCA) for ≥12 months and stable therapy for ≥3 months prior to enrolment.

• OR b) Patients who are unable to tolerate UDCA, and did not receive UDCA for at least 3 months from the date of screening.

• History of confirmed Primary Biliary Cholangitis Diagnosis, based on American Association for the Study of Liver Disease \[AASLD\] and European Association for Study of the Liver \[EASL\] Practice Guidelines; \[Lindor 2009; EASL 2009\], as demonstrated by the presence of at least≥2 of the following 3 diagnostic factors:

‣ History of elevated Alkaline Phosphatase levels for at least 6 months prior to Screening Visit 1

⁃ Positive antimitochondrial antibodies (AMA) titer or if AMA negative or in low titer (\<1:80) PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components \[PDC-E2, 2-oxo-glutaric acid dehydrogenase complex\])

⁃ Liver biopsy consistent with PBC.

• ALP ≥1.67x upper limit of normal (ULN) at Visit 1 and Visit 2 and with \< 30% variance between the levels from Visit 1 to Visit 2.

• Contraception: Female patients must be postmenopausal, surgically sterile, or if premenopausal, agree to use ≥ 1 effective method of contraception during the trial. Effective methods of contraception are considered to be Hormonal (e.g., contraceptive pill, patch, intramuscular implant or injection); or Double barrier method, i.e., (a) condom (male or female) or (b) diaphragm, with spermicide; or Intrauterine device (IUD); or Vasectomy (partner).

• Must provide written informed consent and agree to comply with the trial protocol.