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Clinical trial

A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)

NCT07216235 is registered in ClinicalTrials.gov with Zydus Therapeutics Inc. as lead sponsor.

NCT NCT07216235
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)
Lead sponsor
Zydus Therapeutics Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
March 24, 2026
Completion date
November 30, 2032
Enrollment
386 (estimated)
Sites
3

Conditions

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

primary biliary cholangitis