Saroglitazar Magnesium for Primary Biliary Cirrhosis
What You Need to Know Before You Apply
What is the purpose of this trial?
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as Thiazolidinediones, Fibrates, and other specific drugs, at least 12 weeks before screening. If you're on these medications, you may need to stop them before joining the trial.
Who Is on the Research Team?
Deven Parmar
Principal Investigator
Zydus Therapeutics Inc.
Are You a Good Fit for This Trial?
This trial is for individuals who have completed the SARO.21.001 study on primary biliary cholangitis and agreed to follow the protocol. They must not be heavy drinkers, have a MELD score under 15, or suffer from other liver diseases, unstable heart disease, uncontrolled thyroid issues, muscle diseases, or severe illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Saroglitazar Magnesium 1 mg tablet orally once daily for 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Continuation of treatment to evaluate long-term safety and efficacy
What Are the Treatments Tested in This Trial?
Interventions
- Saroglitazar Magnesium
Saroglitazar Magnesium is already approved in India for the following indications:
- Type 2 diabetes mellitus
- Dyslipidemia
- Non-alcoholic fatty liver disease (NAFLD)
- Non-alcoholic steatohepatitis (NASH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zydus Therapeutics Inc.
Lead Sponsor