Phase 3Recruiting
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)
- Sponsor
- Zydus Therapeutics Inc. (Industry)
- Enrolment
- 386 planned
- Conditions
- Primary Biliary Cholangitis
- Interventions
- Saroglitazar magnesium 1 mg; Placebo
- Ages
- adults, older adults
- Registry
- NCT07216235, CTIS2025-524067-20-00
Full record on ClinicalTrials.gov
From the registry
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
Primary outcomes
- To evaluate the effect of saroglitazar magnesium compared to placebo, based on time to the first occurrence of the defined clinical outcome events in participants with PBC.
History
Primary completion expected
Last registry update
Started
Registered