Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

Exclusion Criteria

• •1. Consumption of \>3 units of alcohol per day (\>21 units per week) if male and \>2 units of alcohol per day (\>14 units per week) if female for at least 3 consecutive months in the last 5 years (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
• •2. History or presence of other concomitant liver diseases including:
• •* Hepatitis B or C virus (HCV, HBV) infection
• •* Primary sclerosing cholangitis (PSC)
• •* Alcoholic liver disease
• •* Definite autoimmune liver disease or overlap syndrome
• •* Non-alcoholic steatohepatitis (NASH)
• •3. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, bilirubin \> 2x ULN, ascites, encephalopathy, known esophageal varices or history of variceal bleeding and active or history of hepatorenal syndrome.
• •4. History of any venous thromboembolism, transient ischemic attack (TIA), intracranial hemorrhage, neoplasm, arteriovenous malformation, vasculitis, bleeding disorder, coagulation disorders or screening blood tests that indicate altered coagulability (e.g. platelet count, activated partial thromboplastin time \[aPTT\], partial thromboplastin time \[PTT\] or thrombin time \[TT\] tests).
• •5. Patients with INR \> upper limit of normal (ULN) at visit 1.
• •6. Patients with total bilirubin \> ULN at visit 1 that is not due to Gilbert's syndrome
• •7. Patients with \>30% increase in ALT, total bilirubin, or Internation normalized ratio (INR) between Visit 1 to Visit 2.
• •8. Patients with serum creatinine \>ULN according to the gender at Visit 1.
• •9. Patients with abnormal total creatine kinase (CK) OR lipase OR amylase at Visit 1.
• •10. Unstable cardiovascular disease, including:
• •* unstable angina, (i.e., new or worsening symptoms of coronary heart disease within the past 3 months), acute coronary syndrome within the past 6 months, acute myocardial infarction in the past 3 months or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, within the past 6 months
• •* history of (within prior 3 months) or current unstable cardiac dysrhythmias
• •* uncontrolled hypertension (systolic blood pressure \[BP\] \>160 mmHg and/or diastolic BP \>100 mmHg)
• •* stroke or transient ischemic attack within the prior 6 months
• •11. History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial nonmelanoma skin cancer.
• •12. Contraindications to Saroglitazar magnesium or has any conditions affecting the ability to evaluate the effects of Saroglitazar magnesium.
• •13. Known allergy, sensitivity or intolerance to the study drug, comparator or formulation ingredients.
• •14. Participation in any other clinical study within the previous 3 months of screening.
• •15. Illicit substance abuse within the past 6 months.
• •16. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, human immunodeficiency virus (HIV), coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption).