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A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Enrollment increased: 400 → 886 participants · Study sites: 0 to 1 · Eligibility criteria expanded, about 14 words · 1 more Show 4 more changesShow less
    • Enrollment increased: 400 → 886 participants
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 14 words
    • Study description expanded, about 73 words
  2. Notable Primary endpoint(s) modified Completion pushed from Aug 30, 2029 to Dec 30, 2032 · Eligibility criteria shortened, about 21 wordsv2 Show 2 more changesShow less
    • Completion pushed from Aug 30, 2029 to Dec 30, 2032
    • Eligibility criteria shortened, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .
Trial Details
NCT Number NCT07581951
Lead Sponsor Haisco Pharmaceutical Group Co., Ltd.
Conditions MASH - Metabolic Dysfunction-Associated Steatohepatitis, NASH (Non-Alcoholic Steatohepatitis)
Enrollment 886 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov