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Completed Phase 1 Interventional

Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function

ClinicalTrials.gov ID: NCT04469920

Public ClinicalTrials.gov record NCT04469920. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 9:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of Pharmacokinetics and Safety of Saroglitazar Magnesium in Participants with Normal Hepatic Function and with Hepatic Impairment, Cholestatic Liver Disease, NASH with Advanced Fibrosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function

Study identification

NCT ID
NCT04469920
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Zydus Therapeutics Inc.
Industry
Enrollment
98 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 16, 2020 (Actual)
Primary completion
Mar 21, 2022 (Actual)
Completion
Mar 21, 2022 (Actual)
Last update posted
Sep 20, 2024

2020 – 2022

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Indiana University School of Medicine Indianapolis Indiana 46202 —
American Research Corporation at Texas Liver Institute San Antonio Texas 78215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04469920, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 20, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04469920 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →