Search > Primary Biliary Cholangitis
90 Participants NeededMy employer runs this trial

Saroglitazar Magnesium for Primary Biliary Cholangitis

(EPICS-IV Trial)

DP
FS
Overseen ByFarheen Shaikh
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Zydus Therapeutics Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who have been diagnosed with primary biliary cholangitis (PBC) and either did not respond well to, or cannot tolerate, UDCA treatment. Participants must meet certain blood test requirements and provide written consent.

Inclusion Criteria

I have taken ursodeoxycholic acid for at least 12 months, with a stable dose for 6 months, or I stopped taking it due to intolerance at least 3 months ago.
4. Average Alkaline Phosphatase at both screening Visits 1 and 2: \> 1× Upper Limit of Normal and \< 1.67× Upper Limit of Normal, and \< 30% variance between both levels
6. Must have given written informed consent (signed and dated).
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Saroglitazar Magnesium

Trial Overview

The study compares Saroglitazar Magnesium (1 mg) to a placebo in people with PBC who haven't fully benefited from or can't take UDCA. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Saroglitazar Magnesium 1 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Zydus Therapeutics Inc.

Lead Sponsor

Trials
16
Recruited
1,100+

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