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Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Sponsor: Arrowhead Pharmaceuticals
Summary
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.
Official title: Phase 3 Single-Arm Open-Label Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent Participants (Age 12 to <18 Years) With Homozygous Familial Hypercholesterolemia (SPRUCE)
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-03
Completion Date
2029-05
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Zodasiran
By sc injection