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Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia

Study acronym: SPRUCE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 17% 12 → 10 participants
See other at-risk trials from Arrowhead Pharmaceuticals

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Study sites: 0 to 2
  2. Start date: Aug 2026 to Oct 2026
    • Enrollment reduced: 12 → 10 participants
    • Secondary endpoints: details revised at 2 of 20 entries
    • Eligibility criteria shortened, about 2 words
  3. Start date: Mar 2026 to Aug 2026
    • Study completion moved earlier from May 2029 to Aug 2028
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will evaluate the efficacy and safety of zodasiran subcutaneous (sc) injection in participants 12 to \<18 years of age with genetically or clinically diagnosed homozygous familial hypercholesterolemia (HoFH) and low-density lipoprotein cholesterol (LDL-C) ≥116 milligrams per deciliter (mg/dL) on maximally tolerated lipid-lowering therapy.
Trial Details
NCT Number NCT07473843
Lead Sponsor Arrowhead Pharmaceuticals
Conditions
(from sponsor)		 Homozygous Familial Hypercholesterolemia
Related terms Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dyslipidemias, Genetic Diseases, Inborn, Homozygous Familial Hypercholesterolemia, Hyperlipidemias, Hyperlipoproteinemia Type II, Hyperlipoproteinemias, Lipid Metabolism Disorders, Lipid Metabolism, Inborn Errors, Metabolic Diseases, Metabolism, Inborn Errors, Nutritional and Metabolic Diseases
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov