NCT05045482

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease

Detailed description

Hepatic impairment study in subjects with cirrhosis secondary to cholestatic disease at a single and multiple once daily doses of Saroglitazar Magnesium needs to be conducted per discussion with FDA. Thus, an extension study has been added.

Conditions

• Hepatic Impairment
• Cirrhosis
• Cholestatic Liver Disease

Interventions

Type	Name	Description
DRUG	Saroglitazar Magnesium 1 mg	Group-8: Total of 18 subjects will be enrolled in the Group-8. Group 8A (n=6, consist of mild hepatic impairment subjects); Group 8B (n=6, consist of moderate hepatic impairment), Group 8C (n=3, consist of severe hepatic impairment and Group 8D (n=3, consist of control subjects with normal hepatic functions).
DRUG	Saroglitazar Magnesium 2 mg	Group-9: Total of 12 subjects will be enrolled in the Group-9. Group 9A (n=3, consist of mild hepatic impairment subjects); Group 9B (n=3, consist of moderate hepatic impairment), Group 9C (n=3, consist of severe hepatic impairment and Group 9D (n=3, consist of control subjects with normal hepatic functions).

Timeline

• Start date: 2021-10-21
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2021-09-16
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study