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Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later across 2 updates Dec 31, 2025 → Dec 31, 2026
See other at-risk trials from Zydus Therapeutics Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 31, 2026 to Dec 31, 2026v7
  2. Primary and study completion pushed from Dec 31, 2025 to Jul 31, 2026v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Aug 31, 2025 to Dec 31, 2025
    • Start date changed from estimate of Aug 31, 2025 to Aug 5, 2025
    • Site details revised
    v5
  4. Start date: May 31, 2025 to Aug 31, 2025v4
  5. Study site revised
    • Study title shortened, about 10 words
    v3
  6. Start date: Mar 31, 2025 to May 31, 2025
    • Study sites: 0 to 1
    • Secondary endpoints revised (11)
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06825559
Lead Sponsor Zydus Therapeutics Inc.
Conditions
(from sponsor)		 Cholestatic Liver Disease
Related terms Liver Cirrhosis, Biliary
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov