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

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

Timeline

Start

2025-08-05

Primary completion

2026-12-31

Completion

2026-12-31

Publications

• Background Vuppalanchi R, Cruz MM, Momin T, Shaikh F, Swint K, Patel H, Parmar D. Pharmacokinetic, Safety, and Pharmacodynamic Profiles of Saroglitazar Magnesium in Cholestatic Cirrhosis With Hepatic Impairment and Participants With Renal Impairment. Clin Pharmacol Ther. 2025 Jan;117(1):240-249. doi: 10.1002/cpt.3450. Epub 2024 Oct 2.

Drugs

Indications