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NCT06427395 · ClinicalTrials.gov registry record · Phase 3

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

A Phase 3 study of Primary Biliary Cholangitis, sponsored by Zydus Therapeutics.

Recruiting
Registry status
Phase 3
Development phase
150
Enrollment target
20
Study locations

NCT06427395 is a Phase 3 study of Primary Biliary Cholangitis that is actively recruiting participants, run by Zydus Therapeutics. The registered enrollment target is 150 participants, below the 188-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT06427395, a Phase 3 study of Primary Biliary Cholangitis, is actively recruiting participants, sponsored by Zydus Therapeutics.

RECRUITING
Registry status
Phase 3
Development phase
150 participants
Enrollment target
20
Study locations

Study Summary

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Conditions Studied

Primary Biliary Cholangitis

Interventions

  • DRUG Saroglitazar Magnesium 1 mg

Study Locations (20)

California

  • Zydus US013 - Los Angeles
  • Zydus US011 - Pasadena
  • Zydus US043 - Sacramento

Florida

  • Zydus US027 - Jacksonville
  • Zydus US006 - Lakewood Rch
  • Zydus US005 - Miami

Buenos Aires

  • Zydus AR001 - Ciudad Autónoma de Buenos Aires
  • Zydus AR007 - Ciudad Autónoma de Buenos Aires
  • Zydus AR006 - Ciudad Autónoma de Buenos Aires

Virginia

  • Zydus US016 - Charlottesville
  • Zydus US039 - Richmond

Colorado

  • Zydus US022 - Aurora

Connecticut

  • Zydus US037 - New Haven

Georgia

  • Zydus US020 - Marietta

Indiana

  • Zydus US001 - Indianapolis

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-07-16
Est. Completion 2027-07-18
Phase Phase 3

Sponsor

Zydus Therapeutics

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06427395

The ClinicalTrials.gov registry entry for NCT06427395 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 188-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (20% lower). The listed sponsor is Zydus Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 1 intervention - of which Saroglitazar Magnesium 1 mg is the first listed.

NCT06427395 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Buenos Aires.

Frequently Asked Questions

What is clinical trial NCT06427395 about?

NCT06427395 is a clinical study titled "Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis". Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

What is the current status of trial NCT06427395?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2024-07-16. Estimated completion is 2027-07-18.

What conditions does trial NCT06427395 study?

This clinical trial studies the following conditions: Primary Biliary Cholangitis.

What interventions are being tested in trial NCT06427395?

The interventions under investigation include: Saroglitazar Magnesium 1 mg (DRUG).

Who is sponsoring clinical trial NCT06427395?

This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06427395 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.