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Clinical trial

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

NCT07424677 is registered in ClinicalTrials.gov with Zydus Therapeutics Inc. as lead sponsor.

NCT NCT07424677
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Zydus Therapeutics Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
August 11, 2026
Completion date
November 30, 2028
Enrollment
90 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

primary biliary cholangitis