Zydus PBC

A randomized, double-blind, placebo-controlled phase 2b/3 study to evaluate the safety and efficacy of Saroglitazar Magnesium in subjects with Primary Biliary Cholangitis (PBC). 

Study phase: Other

Study phase (if other): 2b/3

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

18-75 years of age 
Confirmed PBC diagnosis 
Elevated ALP on labs 
No history of cirrhosis with complications, unstable cardiovascular disease, or uncontrolled thyroid disorder 
No use of TZDs, OCA, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide or other systemic corticosteroids 

 

Please contact the study coordinator for additional eligibility information.   

Primary disease category: Liver

Secondary disease categories: Liver

Sponsor: Zydus Therapeutics Inc.

Protocol number: SARO.21.001

Projected enrollment dates: October 2022

Official study title: 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

ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/https://clinicaltrials.gov/ct2/show/NCT05133336