drugset / Trial / NCT07037771

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

NCT07037771 ↗

Phase 3 Recruiting 60 enrolled Arrowhead Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2025-06-17
Primary completion
2027-08-20
Completion
2027-08-20

Drugs

EvaluationDrugModalityDoseRoute
Subject zodasiran Small interfering RNA (siRNA) — Subcutaneous