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A Phase 3 Study of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE)

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Enrollment increased: 60 → 70 participants
    • Site details revised at 43 of 43 sites
    v12
  2. Study sites: 42 to 43v11
  3. Trial sites expanded: 35 → 42 locationsv10
  4. Trial sites expanded: 32 → 35 locations
    • Trial sites expanded: 22 → 32 locations
    v9
  5. Study sites: 22 to 32v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 16 to 22
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints revised (14)
    v7
  2. Study sites: 8 to 16
    • Eligibility criteria expanded, about 40 words
    v6
  3. Study sites: 2 to 8v5
  4. Study sites: 1 to 2v4
  5. Study title expanded, about 1 wordv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 16, 2025 to Jun 17, 2025
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints revised (14)
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of zodasiran subcutaneous (SC) injection in subjects 12 years of age and older with genetically or clinically diagnosed Homozygous familial hypercholesterolemia (HoFH). After completion of the double blind (DB) treatment period subjects will be eligible to continue in the optional open-label extension (OLE) period of the study. All placebo subjects who opt to continue will transition to active drug during the OLE Period.
Trial Details
NCT Number NCT07037771
Lead Sponsor Arrowhead Pharmaceuticals
Conditions
(from sponsor)		 Homozygous Familial Hypercholesterolemia
Related terms Homozygous Familial Hypercholesterolemia
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov