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NCT05045482 · ClinicalTrials.gov registry record · Phase 1

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

A Phase 1 study of Cirrhosis and Hepatic Impairment, sponsored by Zydus Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT05045482 is a Phase 1 study of Cirrhosis and Hepatic Impairment that is actively recruiting participants, run by Zydus Therapeutics. The registered enrollment target is 30 participants, below the 90,408-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05045482, a Phase 1 study of Cirrhosis and Hepatic Impairment, is actively recruiting participants, sponsored by Zydus Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease

Interventions

  • DRUG Saroglitazar Magnesium 1 mg
  • DRUG Saroglitazar Magnesium 2 mg

Study Locations (1)

Indiana

  • Zydus US002 - Indianapolis

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2021-10-21
Est. Completion 2026-03-31
Phase Phase 1

Sponsor

Zydus Therapeutics

15 total trials

What the Registry Record Tells You About NCT05045482

The ClinicalTrials.gov registry entry for NCT05045482 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90,408-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The listed sponsor is Zydus Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Saroglitazar Magnesium 1 mg is the first listed.

NCT05045482 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT05045482 about?

NCT05045482 is a clinical study titled "Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease". A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease

What is the current status of trial NCT05045482?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-10-21. Estimated completion is 2026-03-31.

What conditions does trial NCT05045482 study?

This clinical trial studies the following conditions: Cirrhosis, Hepatic Impairment, Cholestatic Liver Disease.

What interventions are being tested in trial NCT05045482?

The interventions under investigation include: Saroglitazar Magnesium 1 mg (DRUG), Saroglitazar Magnesium 2 mg (DRUG).

Who is sponsoring clinical trial NCT05045482?

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

Where is trial NCT05045482 being conducted?

This trial has 1 study location across Indiana. 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.