clinical trial · NCT07424677
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy
Primary Biliary CholangitisSaroglitazar Magnesium 1 mgPlacebo
brief summary
Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy
started
Jun 1, 2026
primary completion
Jul 1, 2028
completion
Nov 1, 2028
last updated
May 12, 2026
detailed description
A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy of Saroglitazar Magnesium 1 mg on normalization of ALP in patients having ALP \> ULN to \< 1.67xULN and on Ursodeoxycholic Acid for 12 months or intolerant to Ursodeoxycholic Acid.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol