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NCT06825559 · ClinicalTrials.gov registry record · Phase 1
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
A Phase 1 study of Cholestatic Liver Disease, sponsored by Zydus Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT06825559 is a Phase 1 study of Cholestatic Liver Disease that is actively recruiting participants, run by Zydus Therapeutics. The registered enrollment target is 6 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06825559, a Phase 1 study of Cholestatic Liver Disease, is actively recruiting participants, sponsored by Zydus Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Conditions Studied
Interventions
- DRUG Saroglitazar Magnesium 1 mg
Study Locations (1)
Indiana
- Zydus Site US001 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2025-08-05 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06825559
The ClinicalTrials.gov registry entry for NCT06825559 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zydus Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cholestatic Liver Disease appearing as the primary indexed condition, and to 1 intervention - of which Saroglitazar Magnesium 1 mg is the first listed.
NCT06825559 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT06825559 about?
NCT06825559 is a clinical study titled "Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease". Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
What is the current status of trial NCT06825559?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2025-08-05. Estimated completion is 2025-12-31.
What conditions does trial NCT06825559 study?
This clinical trial studies the following conditions: Cholestatic Liver Disease.
What interventions are being tested in trial NCT06825559?
The interventions under investigation include: Saroglitazar Magnesium 1 mg (DRUG).
Who is sponsoring clinical trial NCT06825559?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06825559 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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