Clinical Trial

Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated July 28, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Protocol Amendment History 2 changes
notable Primary completion pushed: 2025-12-31 -> 2026-07-31 2026-07-29
minor Completion pushed: 2025-12-31 -> 2026-07-31 2026-07-29
Trial Details
NCT Number NCT06825559
Lead Sponsor Zydus Therapeutics Inc.
Conditions Cholestatic Liver Disease
Enrollment 6 participants
Start Date 2025-08-05
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28