Saroglitazar Magnesium for Primary Biliary Cholangitis (EPICS-III Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Verified Trial

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.

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

Treatment Details

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.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Saroglitazar Magnesium 2 mgExperimental Treatment2 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 mgExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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