Saroglitazar Magnesium for Primary Biliary Cholangitis

(EPICS-III Trial)

Recruiting at 60 trial locations

Overseen By Farheen Shaikh

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Zydus Therapeutics Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests Saroglitazar Magnesium tablets on patients with Primary Biliary Cholangitis to see if it can help their liver work better and reduce inflammation.

Research Team

Deven V Parmar, MD

Principal Investigator

Zydus Therapeutics Inc.

Eligibility Criteria

Adults aged 18-75 with Primary Biliary Cholangitis (PBC) are eligible for this trial. They must have had elevated liver enzyme levels for at least 6 months and either be on a stable dose of Ursodeoxycholic acid or unable to tolerate it. A confirmed PBC diagnosis according to specific guidelines is required, but those with other liver diseases, certain medical conditions, or recent participation in another clinical study cannot join.

Inclusion Criteria

You have been diagnosed with Primary Biliary Cirrhosis

Exclusion Criteria

I do not have unstable heart conditions.

I have been drinking up to 2 drinks a day if male, or 1 if female, for the last 3 months.

I have no health issues that would interfere with Saroglitazar Magnesium treatment.

Treatment Details

Interventions

• Placebo (Drug)
• Saroglitazar Magnesium (PPAR Agonist)

Trial Overview The trial is testing Saroglitazar Magnesium tablets at two different doses (1 mg and 2 mg) against a placebo to treat patients with PBC. The goal is to see if these tablets can help manage the condition better than not taking them.

Participant Groups

Group I: Saroglitazar Magnesium 2 mg Experimental Treatment 2 Interventions

Subjects who received Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast are switched to Saroglitazar Magnesium 1 mg for remaining of the treatment period

Group II: Saroglitazar Magnesium 1 mg Experimental Treatment 1 Intervention

Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (52 weeks).

Group III: Placebo Placebo Group 1 Intervention

Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (52 weeks).

Who Is Running the Clinical Trial?

Zydus Therapeutics Inc.

Lead Sponsor

Trials

16

Recruited

1,100+