A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium on Normalization of Alkaline Phosphatase Levels in Patients With Primary Biliary Cholangitis and an Incomplete Response or Intolerance to Ursodeoxycholic Acid

Inclusion Criteria: 1. Adults between 18 and 80 years of age (both inclusive at screening) 2. History of confirmed Primary Biliary Cholangitis diagnosis 3. Ursodeoxycholic acid treatment for at least 12 months and a stable dose for at least 6 months prior to first screening visit OR intolerant to Ursodeoxycholic acid (last dose of Ursodeoxycholic acid at least 3 months prior to first screening visit). 4. Average Alkaline Phosphatase at both screening Visits 1 and 2: \> 1× Upper Limit of Normal and \< 1.67× Upper Limit of Normal, and \< 30% variance between both levels 5. Total bilirubin ≤ 2 x…