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) (EPICS-V)

NCT07216235 Phase 3 NOT_YET_RECRUITING

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

Details

Lead sponsor	Zydus Therapeutics Inc.
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	386
Start date	2026-02
Completion	2032-11

Conditions

• Primary Biliary Cholangitis

Interventions

• Saroglitazar magnesium 1 mg
• Placebo

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. — baseline to 48 months
  Time from randomization to the first occurrence of any of the following clinical outcome events: * Liver decompensation * Change in the Model for End-Stage Liver Disease-Na score to ≥15, measured on 2 consecutive occasions, performed at least 2 weeks apart, without the presence of any competing etiologies. * Liver transplant. * Death (liver- and nonliver-related). * Progression to clinically significant portal hypertension, including the variceal related outcomes * Progression to Child-Pugh-Turcotte C, defined as Child-Pugh-Turcotte score ≥10, measured at 2 consecutive time points at least 4 weeks apart with no competing etiologies