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Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
Sponsor: Arrowhead Pharmaceuticals
Summary
The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 (plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Familial Chylomicronemia Syndrome
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2021-12-14
Completion Date
2026-04
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
Plozasiran
ARO-APOC3 subcutaneous (SC) injection
Placebo
sterile normal saline (0.9% NaCl) SC injection
Locations (58)
Clinical Site 1
Boca Raton, Florida, United States
Clinical Site 2
Suwanee, Georgia, United States
Clinical Site 3
Indianapolis, Indiana, United States
Clinical Site 4
Elkridge, Maryland, United States
Clinical Site 5
St Louis, Missouri, United States
Clinical Site 7
New York, New York, United States
Clinical Site 6
New York, New York, United States
Clinical Site 8
Austin, Texas, United States
Clinical Site 9
Norfolk, Virginia, United States
Clinical Site 10
Córdoba, Argentina
Clinical Site 11
Formosa, Argentina
Clinical Site 14
Camperdown, New South Wales, Australia
Clinical Site 15
St Leonards, New South Wales, Australia
Clinical Site 16
Melbourne, Victoria, Australia
Clinical Site 12
Melbourne, Australia
Clinical Site 13
Nedlands, Australia
Clinical Site 17
Graz, Austria
Clinical Site 18
Edegem, Belgium
Clinical Site 19
Ghent, Belgium
Clinical Site 20
Leuven, Belgium
Clinical Site 21
Liège, Belgium
Clinical Site 22
London, Ontario, Canada
Clinical Site 23
Toronto, Ontario, Canada
Clinical Site 24
Chicoutimi, Quebec, Canada
Clinical Site 25
Montreal, Quebec, Canada
Clinical Site 26
Québec, Quebec, Canada
Clinical Site 27
Zagreb, Croatia
Clinical Site 29
Marseille, Cedez 05, France
Clinical Site 28
Paris, France
Clinical Site 30
Jena, Germany
Clinical Site 31
Leipzig, Germany
Clinical Site 32
Galway, Ireland
Clinical Site 33
Jerusalem, Israel
Clinical Site 34
Chiba, Japan
Clinical Site 35
Ishikawa, Japan
Clinical Site 36
Osaka, Japan
Clinical Site 37
Tochigi, Japan
Clinical Site 38
Tokyo, Japan
Clinical Site 39
Tokyo, Japan
Clinical Site 41
Tlalpan, Mexico DF, Mexico
Clinical Site 42
Cuernavaca, Morelos, Mexico
Clinical Site 40
Mexico City, Mexico
Clinical Site 44
Auckland, New Zealand
Clinical Site 43
Auckland, New Zealand
Clinical Site 45
Christchurch, New Zealand
Clinical Site 46
Muscat, Oman
Clinical Site 47
Lodz, Poland
Clinical Site 48
Belgrade, Serbia
Clinical Site 49
Niš, Serbia
Clinical Site 50
Singapore, Singapore
Clinical Site 51
Gwangju, South Korea
Clinical Site 52
Seoul, South Korea
Clinical Site 53
A Coruña, Spain
Clinical Site 54
Granada, Spain
Clinical Site 55
Madrid, Spain
Clinical Site 56
Santiago de Compostela, Spain
Clinical Site 58
Melikgazi, Kayseri, Turkey (Türkiye)
Clinical Site 57
Izmir, Turkey (Türkiye)