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Clinical Trials in the USA / NCT07037771
Active, not recruiting Phase 3

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

NCT07037771 · tracked via the Priya Life Science USA tracker
Sponsor
Arrowhead Pharmaceuticals
Phase
Phase 3
Started
2025-06-17
Last updated
2026-08-12

Condition(s) studied

Homozygous Familial Hypercholesterolemia

Investigational drug(s) / intervention(s)

zodasiran InjectionPlacebo

zodasiran Injection: ARO-ANG3 Injection

Placebo: sterile normal saline (0.9% NaCl)

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age ≥12 years, non pregnant, non lactating, do not plan to become pregnant during the study * Body weight ≥35 kg at Screening as patients could theoretically be \<35 kg as the study continues. * HoFH based on a supportive genetic test or a clinical diagnosis (total cholesterol \>500 mg/dL\[13 mmol/L\] OR treated LDL-C concentration of ≥300 mg/dL \[≥8 mmol/L\] either accompanied by TGs \<300 mg/dL \[3.4 mmol/L\] AND both parents with documented total cholesterol \>250 mg/dL \[6.5 mmol/L\] OR cutaneous or tendinous xanthoma before 10 years of age) * LDL-C ≥70 mg/dL (1.8 mmol/L). For adolescents 12 to \<18 years of age, screening LDL-C ≥116 mg/dL (3 mmol/L). * Hemoglobin A1c (HbA1c) ≤9.5% * Total bilirubin \<2xULN, unless in previously confirmed cases of Gilbert's syndrome * Alanine aminotransferase or aspartate aminotransferase \<3×ULN * On standard of care, maximally tolerated lipid-lowering therapy to include a maximally tolerated statin, ezetimibe, and a PCSK9 inhibitor Exclusion Criteria: * Use of a hepatocyte-targeted siRNA within 365 days before Day 1 (except inclisiran, which is permitted; administration of inclisiran and study drug must be separated by at least 4 weeks) * Use of an antisense oligonucleotide molecule within 3 months before Day 1 (except inclisiran, which is permitted; administration of inclisiran and study drug must be separated by at least 4 weeks) * Use of evinacumab within 3 months before Day 1. Evinacumab use is prohibited during the study. * Non-response to evinacumab, defined as LDL-C reduction \<15% from baseline after 2 doses * Use of any other investigational agent or device within 30 days or 5 half-lives (whichever is longer) before Day 1 * Use of systemic corticosteroids (unless used as replacement therapy for pituitary/adrenal disease with a stable regimen) * Estimated glomerular filtration rate \<30 mL/min NOTE: Additional Inclusion/exclusion criteria may apply per protocol

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Research Site 7 Park Ridge Illinois
Research Site 2 New York New York
Research Site 1 Cincinnati Ohio
Research Site 14 Pittsburgh Pennsylvania
Research Site 13 Camperdown New South Wales
Research Site 9 Saint Leonards New South Wales
Research Site 21 Heidelberg Victoria
Research Site 3 Nedlands Western Australia
Research Site 40 Innsbruck Austria
Research Site 39 Linz Austria
Research Site 42 Vienna Austria
Research Site 37 Vienna Austria
Research Site 33 La Louvière Belgium
Research Site 34 Leuven Belgium
Research Site 24 Cerqueira César São Paulo
Research Site 5 Vancouver British Columbia
Research Site 6 Chicoutimi Quebec
Research Site 4 Québec Canada
Research Site 30 Hradec Králové Czechia
Research Site 23 Paris France
Research Site 17 Tbilisi Georgia
Research Site 18 Tbilisi Georgia
Research Site 19 Tbilisi Georgia
Research Site 35 Berlin Germany
Research Site 10 Jerusalem Israel
Research Site 15 Tel Litwinsky Israel
Research Site 26 Kanazawa Ishikawa-ken
Research Site 27 Suita Osaka
Research Site 20 Fukushima Japan
Research Site 16 Okayama Japan
Research Site 22 Saitama Japan
Research Site 25 Tokyo Japan
Research Site 12 Christchurch New Zealand
Research Site 31 Riyadh Saudi Arabia
Research Site 11 Parktown Johannesburg
Research Site 8 Cape Town South Africa
Research Site 43 Barcelona Spain
Research Site 28 Córdoba Spain
Research Site 29 Madrid Spain
Research Site 32 Gothenburg Sweden

+ 3 more sites — see the full list on the official registry below.

More Arrowhead Pharmaceuticals trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07037771 on ClinicalTrials.gov ↗ ← All trials in the USA