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A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: May 2031 to May 24, 2031 Completion date: Jun 2031 to Jun 28, 2031 · Eligibility criteria shortened, about 12 words · Secondary endpoints: 24 to 26v3 Show 3 more changesShow less
    • Completion date: Jun 2031 to Jun 28, 2031
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints: 24 to 26

    See this version in full on ClinicalTrials.gov ↗

  2. Recruitment opened Start date changed from estimate of May 2026 to May 29, 2026 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of May 2026 to May 29, 2026
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.
Trial Details
NCT Number NCT07551492
Lead Sponsor Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions Atherosclerotic Cardiovascular Disease
Enrollment 9,262 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov