Primary Biliary Cholangitis


A phase 2, prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium in patients with primary biliary cholangitis (PBC)

Sponsor: Zydus Discovery DMCC

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03112681

Enrollment status: OPEN

Objective

The sponsor is conducting this study to evaluate the safety, tolerability, and efficacy of the investigational drug saroglitazar magnesium in patients with PBC. This drug is labelled investigational because it has not been approved by the Food and Drug Administration (FDA) for the treatment of PBC.

Inclusion criteria

Exclusion criteria

Study design

Principal investigator: Fred Askari, MD, PhD faskari@med.umich.edu

Study coordinator: Jenna Penterics, (734) 764-4911 or jepenter@med.umich.edu