A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis

Study acronym: PURIFY-TIMI 81
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites expanded: 40 → 56 locations
    • Interventions: YN001/Placebo 0mg (Drug), YN001/Placebo 20mg (Drug), YN001/Placebo 40mg (Drug) to YN001/Placebo 0mg (Drug), YN001/Placebo 20mg (Drug), YN001/Placebo 40mg (Drug)
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 2 of 13 entries
  2. Study sites: 39 to 40v5
  3. Trial sites expanded: 28 → 39 locationsv4
  4. Recruitment opened
    • Start date changed from estimate of Jul 30, 2026 to Jul 31, 2026
    • Site details revised at 28 of 28 sites
    v3
  5. Start date: Apr 30, 2026 to Jul 30, 2026
    • Trial sites expanded: 13 → 28 locations
    v2
  6. Study First Submitted
  • 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.
This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.
Trial Details
NCT Number NCT07521007
Lead Sponsor Beijing Inno Medicine Co., Ltd.
Collaborators: The TIMI Study Group
Conditions
(from sponsor)		 Atherosclerosis, Coronary Artery Disease
Related terms Atherosclerosis, Coronary Artery Disease
Enrollment 456 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov