A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment with Cirrhosis Due to Cholestatic Liver Disease
Latest Information Update: 30 Oct 2025
At a glance
- Drugs Saroglitazar (Primary)
- Indications Biliary cirrhosis; Liver disorders
- Focus Pharmacokinetics
- Sponsors Zydus Pharmaceuticals (USA)
Most Recent Events
- 24 Oct 2025 Planned End Date changed from 31 Aug 2025 to 31 Dec 2025.
- 24 Oct 2025 Planned primary completion date changed from 31 Aug 2025 to 31 Dec 2025.
- 24 Oct 2025 Status changed from not yet recruiting to recruiting.