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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: Recruiting Phase 1 study of Cirrhosis and Hepatic Impairment, sponsored by Zydus Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To measure the plasma concentration of Saroglitazar (parent compound) and estimate the AUCt following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function.
Conditions Studied
Interventions
- DRUG Saroglitazar Magnesium 1 mg
- DRUG Saroglitazar Magnesium 2 mg
Study Locations (1)
Indiana
- Zydus US002 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-10-21 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What NCT05045482 shows while recruiting
NCT05045482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 90,408-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cirrhosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05045482's enrollment target sits among peer trials
30 31st of 53 higher than 13 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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