Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

PHASE3Not yet recruitingINTERVENTIONAL

Enrollment

386

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

November 30, 2032

Study Completion Date

November 30, 2032

Conditions

Primary Biliary Cholangitis

Interventions

DRUG

Saroglitazar magnesium 1 mg

Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast

DRUG

Placebo

Matching Placebo once daily, orally each morning before breakfast

All Listed Sponsors

lead

Zydus Therapeutics Inc.

INDUSTRY