Clinical Trial

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Name: Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis — clinical trial record (NCT06427395)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Active, Not Recruiting Phase 3

View on ClinicalTrials.gov →

Summary

Protocol Amendment History 2 changes

critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-13

notable Enrollment reduced: 150 -> 102 participants 2026-05-13

Trial Details

NCT Number	NCT06427395
Lead Sponsor	Zydus Therapeutics Inc.
Conditions	Primary Biliary Cholangitis
Enrollment	102 participants
Start Date	2024-07-16
Primary Completion	2027-04-18 (estimated)
Study Completion	2027-07-18 (estimated)
Updated on ClinicalTrials.gov	2026-05-12