NCT07216235

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 386 (estimated)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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)

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-01
• Primary completion: 2032-11-01
• Completion: 2032-11-01
• First posted: 2025-10-14
• Last updated: 2026-02-18

Regulatory

• FDA-regulated drug study