Saroglitazar Magnesium in Primary Biliary Cholangitis

Summary

This study focuses on individuals who are 18-75 years old and have a confirmed diagnosis of primary biliary cholangitis (PBC). PBC is a progressive inflammatory disease leading to destruction of the bile ducts and scarring of the liver. The purpose of the study is to explore the treatment effect of an investigational drug called saroglitazar magnesium (saroglitazar) as a possible treatment for PBC. Previous studies suggest that saroglitazar may improve liver enzymes and lipid profiles in people with PBC. Researchers will evaluate the effectiveness and safety of saroglitazar’s optimal dose and placebo (inactive substance) in patients with PBC.


Inclusion Criteria

  • Males or females, between 18 and 75 years of age, both inclusive at screening.
  • Subjects on Ursodeoxycholic acid (UDCA) for at least 12 months at a therapeutic dose (at least 13 mg/kg per day) and a stable dose for 6 months prior to Screening Visit and having ALP ≥ 1.67 x ULN.
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Study Location(s)

Beverly

More about this Clinical Trial

Full 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

Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

II/III

IRB Number

STUDY00002021

ClinicalTrials.gov ID

NCT05133336

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

II/III

IRB Number

SARO-21-001

ClinicalTrials.gov ID

NCT05133336

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?