NCT05133336

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)

Detailed description

A Multicenter, Randomized, Double-blind, Placebo controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Saroglitazar Magnesium 1 mg	Subjects randomized to Saroglitazar Magnesium 1 mg arm will receive Saroglitazar Magnesium 1 mg treatment for the entire treatment period up to Week 52.
DRUG	Saroglitazar Magnesium 2 mg	Subjects randomized to Saroglitazar Magnesium 2 mg arm are switched to Saroglitazar Magnesium 1 mg treatment up to Week 52
DRUG	Placebo	Subjects randomized to placebo arm will receive placebo treatment for the entire treatment period up to Week 52.

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-04-30
• Completion: 2025-05-07
• First posted: 2021-11-24
• Last updated: 2025-06-15

Locations

57 sites across 4 countries: United States, Argentina, Iceland, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study