What side effects are associated with this type of intervention?

Common treatments for Primary Biliary Cirrhosis (PBC) include obeticholic acid, fibrates, and PPAR agonists like Saroglitazar Magnesium. Obeticholic acid can cause pruritus, fatigue, and abdominal pain. Fibrates, such as fenofibrate, may lead to gastrointestinal disturbances, elevated liver enzymes, and muscle pain. PPAR agonists, including Saroglitazar Magnesium, may have side effects like weight gain, edema, and potential cardiovascular risks. It is important to monitor liver function and other potential adverse effects during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Primary Biliary Cirrhosis (PBC), including ursodeoxycholic acid (UDCA) and obeticholic acid. UDCA is a bile acid that helps to improve bile flow and reduce liver damage. Obeticholic acid, a farnesoid X receptor (FXR) agonist, works by reducing bile acid production and inflammation. While these treatments are not PPAR-α and PPAR-γ agonists like Saroglitazar Magnesium, they target pathways involved in bile acid metabolism and liver inflammation, which are crucial in managing PBC.

What other types of research exist?

Promising novel alternatives to Saroglitazar Magnesium for Primary Biliary Cirrhosis patients include Pemafibrate, a selective peroxisome proliferator-activated receptor alpha modulator (SPPARM-α), and Bezafibrate, which has shown efficacy in clinical trials. Both drugs are used in combination with ursodeoxycholic acid (UDCA) for patients with an incomplete response to UDCA alone.

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

Verified Trial

Phase 2 & 3

Recruiting

Research Sponsored by Zydus Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

You have been diagnosed with Primary Biliary Cirrhosis

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to weeks 4, 8,16, 24 and 52

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Saroglitazar Magnesium may include changes in liver enzymes, fatigue, gastrointestinal issues like nausea or diarrhea, possible allergic reactions, and muscle pain or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to weeks 4, 8,16, 24 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to weeks 4, 8,16, 24 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to weeks 4, 8,16, 24 and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To measure biochemical response of Saroglitazar Magnesium Optimal Dose (1 or 2 mg) relative to Placebo based on the composite endpoints of Alkaline Phosphatase (ALP) and total bilirubin

Secondary study objectives

To analyze the treatment-related adverse events/Serious adverse events (as assessed by CTCAE V 5.0 or higher) of Saroglitazar Magnesium 1 mg/Optimal Dose (1 or 2 mg) and Saroglitazar Magnesium 2 mg/Optimal Dose (1 or 2 mg) relative to Placebo.

To assess the change in Pruritus using 5-Domains (5-D) itch scale following treatment with Saroglitazar Magnesium 1 mg/Optimal Dose (1 or 2 mg) and Saroglitazar Magnesium 2 mg/Optimal Dose (1 or 2 mg) relative to Placebo

To assess the change in Pruritus using Patient Global Impression of Change scale following treatment with Saroglitazar Magnesium 1 mg/Optimal Dose (1 or 2 mg) and Saroglitazar Magnesium 2 mg/Optimal Dose (1 or 2 mg) relative to Placebo

+16 more

Other study objectives

To evaluate the effect of Saroglitazar Magnesium Optimal Dose (1 or 2 mg) relative to Placebo with changes in 7α-hydroxy-4-cholesten-3-one (C4)

To evaluate the effect of Saroglitazar Magnesium Optimal Dose (1 or 2 mg) relative to Placebo with changes in fibroblast growth factor 19

To evaluate the effect of Saroglitazar Magnesium Optimal Dose (1 or 2 mg) relative to Placebo with respect to change in controlled attenuation parameter (CAP) assessed by Fibroscan®

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Saroglitazar Magnesium 2 mgExperimental Treatment1 Intervention

Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (52 weeks).

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Saroglitazar Magnesium 2 mg

2020

Completed Phase 1

~100

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Primary Biliary Cirrhosis (PBC) include Ursodeoxycholic Acid (UDCA), Obeticholic Acid, and fibrates such as Bezafibrate. UDCA works by reducing the toxicity of bile acids, thereby protecting liver cells and improving bile flow. Obeticholic Acid, a potent farnesoid X receptor agonist, helps regulate bile acid synthesis and reduces liver inflammation. Fibrates, including Bezafibrate, activate peroxisome proliferator-activated receptors (PPARs), which improve lipid metabolism and reduce liver inflammation. Saroglitazar Magnesium, a PPAR-α and PPAR-γ agonist, similarly targets these pathways to enhance lipid metabolism and reduce inflammation. These mechanisms are crucial for PBC patients as they help slow disease progression, improve liver function, and alleviate symptoms.

Fibrate treatment for primary biliary cirrhosis.A novel treatment for refractory primary biliary cirrhosis?