RecruitingPhase 3NCT07037771

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

Phase 3 Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE)


Sponsor

Arrowhead Pharmaceuticals

Enrollment

60 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called zodasiran Injection for people with homozygous familial hypercholesterolemia. The study is currently recruiting participants at 43 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGzodasiran Injection

ARO-ANG3 Injection

DRUGPlacebo

sterile normal saline (0.9% NaCl)


Locations(43)

Research Site 7

Park Ridge, Illinois, United States

Research Site 2

New York, New York, United States

Research Site 1

Cincinnati, Ohio, United States

Research Site 14

Pittsburgh, Pennsylvania, United States

Research Site 13

Camperdown, New South Wales, Australia

Research Site 9

Saint Leonards, New South Wales, Australia

Research Site 21

Heidelberg, Victoria, Australia

Research Site 3

Nedlands, Western Australia, 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, Brazil

Research Site 5

Vancouver, British Columbia, Canada

Research Site 6

Chicoutimi, Quebec, Canada

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, Japan

Research Site 27

Suita, Osaka, Japan

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, South Africa

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

Research Site 36

Afyonkarahisar, Turkey (Türkiye)

Research Site 41

Bornova/Izmir, Turkey (Türkiye)

Research Site 38

Melikgazi/Kayseri, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT07037771


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