A Phase 3 Study of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE)
Start Date
6/17/2025
Completion Date
8/20/2027
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 Criteria
Age Range: 12 years to No maximum
Interventions
zodasiran Injection
Placebo
Conditions
Locations
Research Site 7
Park Ridge, Illinois 60068
United States
Research Site 2
New York, New York 10029
United States
Research Site 1
Cincinnati, Ohio 45227
United States
Research Site 14
Pittsburgh, Pennsylvania 15213
United States
Research Site 13
Camperdown, New South Wales 2050
Australia
Research Site 9
Saint Leonards, New South Wales 2065
Australia
Research Site 21
Heidelberg, Victoria 3084
Australia
Research Site 3
Nedlands, Western Australia 6009
Australia
Research Site 40
Innsbruck, 6020
Austria
Research Site 39
Linz, 4021
Austria
Research Site 42
Vienna, 1090
Austria
Research Site 37
Vienna, 1130
Austria
Research Site 33
La Louvière, 7100
Belgium
Research Site 34
Leuven, 3000
Belgium
Research Site 24
Cerqueira César, São Paulo CEP-05403-000
Brazil
Research Site 5
Vancouver, British Columbia V6Z 2H2
Canada
Research Site 6
Chicoutimi, Quebec G7H 7K9
Canada
Research Site 4
Québec, G1V 4W2
Canada
Research Site 30
Hradec Králové, General E3 500 0
Czechia
Research Site 23
Paris, 75013
France
Research Site 17
Tbilisi, 0159
Georgia
Research Site 18
Tbilisi, 160
Georgia
Research Site 19
Tbilisi, 186
Georgia
Research Site 35
Berlin, 13353
Germany
Research Site 10
Jerusalem, 9112001
Israel
Research Site 15
Tel Litwinsky, 5265601
Israel
Research Site 26
Kanazawa, Ishikawa-ken 920-8641
Japan
Research Site 27
Suita, Osaka 564-8565
Japan
Research Site 20
Fukushima, 960-1295
Japan
Research Site 16
Okayama, 700-8558
Japan
Research Site 22
Saitama, 350-0495
Japan
Research Site 25
Tokyo, 113-8510
Japan
Research Site 12
Christchurch, 8011
New Zealand
Research Site 31
Riyadh, 12713
Saudi Arabia
Research Site 11
Parktown, Johannesburg 2193
South Africa
Research Site 8
Cape Town, 7925
South Africa
Research Site 43
Barcelona, 8907
Spain
Research Site 28
Córdoba, 14004
Spain
Research Site 29
Madrid, 28041
Spain
Research Site 32
Gothenburg, 413 46
Sweden
Research Site 36
Afyonkarahisar, 03200
Turkey (Türkiye)
Research Site 41
Bornova/Izmir, 35100
Turkey (Türkiye)
Research Site 38
Melikgazi/Kayseri, 38030
Turkey (Türkiye)