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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
Awards & highlights

EPICS-III Trial Summary

This trial is testing a new drug for the treatment of PBC, a disease affecting the bile ducts.

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.Check my eligibility
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.See study design
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.

EPICS-III Trial Eligibility Criteria

Inclusion Criteria

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

EPICS-III Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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®

EPICS-III 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).

Find a Location

Who is running the clinical trial?

Zydus Therapeutics Inc.Lead Sponsor
13 Previous Clinical Trials
1,009 Total Patients Enrolled
Deven V Parmar, MDStudy DirectorZydus Therapeutics Inc.
1 Previous Clinical Trials
124 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05133336 — Phase 2 & 3
Primary Biliary Cirrhosis Research Study Groups: Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 1 mg, Placebo
Primary Biliary Cirrhosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05133336 — Phase 2 & 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05133336 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are included in the total sample size for this research project?

"Yes, this is an ongoing trial that was originally posted on April 1st, 2022 and last updated less than a month ago. The goal is to have 192 patients enrolled at a single site."

Answered by AI

Could I possibly qualify to take part in this experiment?

"This clinical trial is currently looking for 192 participants that have been diagnosed with cholangitis and fall within the age range of 18 to 75."

Answered by AI

Does this research project have an age limit?

"The age limit for this trial is 75 years old, and all candidates must be of legal age (18+)."

Answered by AI

Can patients currently enroll in this trial?

"Yes, this is an active trial that was posted on April 1st, 2020 and last updated a month ago. The goal is to find 192 participants from a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Zydus US022
Zydus US005
Other
Zydus US002
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I do have clover chirosis n I'm looking for ways so I can try n live longer.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis
2022. "Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05133336.
All > Tandem > Primary Biliary Cirrhosis
~7 spots leftby Jun 2024
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