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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: Recruiting Phase 1 study of Cholestatic Liver Disease, sponsored by Zydus Therapeutics.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Maximum plasma concentration (Cmax)
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 |
What NCT06825559 shows while recruiting
NCT06825559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cholestatic Liver Disease
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 NCT06825559's enrollment target sits among peer trials
6 1975th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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