Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
NCT ID: NCT05089084
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
75 participants
INTERVENTIONAL
2022-01-11
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ARO-APOC3 (plozasiran)
4 doses of plozasiran by subcutaneous (sc) injection (randomized period)
8 doses of plozasiran by sc injection (open-label period)
Plozasiran
ARO-APOC3 injection
Placebo
calculated volume to match active treatment by sc injection (randomized period)
Placebo
sterile normal saline (0.9% NaCl)
Interventions
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Plozasiran
ARO-APOC3 injection
Placebo
sterile normal saline (0.9% NaCl)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of FCS
* Willing to follow dietary counseling as per investigator judgement based on local standard of care
* Participants of childbearing potential (males \& females) must use highly-effective contraception during the study and for at least 24 weeks following the last dose of study medication. Males must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
* Women of childbearing potential must have a negative pregnancy test at Screening and cannot be breastfeeding
* Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
Exclusion Criteria
* Diabetes mellitus newly diagnosed within 12 weeks of Screening or where HbA1c ≥ 9.0% at Screening
* Active pancreatitis within 12 weeks before Day 1
* History of acute coronary syndrome event within 24 weeks of Day 1
* History of major surgery within 12 weeks of Day 1
* Uncontrolled hypertension
* On treatment with human immunodeficiency virus (HIV) antiretroviral therapy
* Seropositive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
* New York Heart Association (NYHA) Clas II, III, or IV heart failure
18 Years
ALL
No
Sponsors
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Arrowhead Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
Herman Clinical Research, LLC
Suwanee, Georgia, United States
Ascension St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, United States
Centennial Medical Group
Elkridge, Maryland, United States
Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research
St Louis, Missouri, United States
New York University Langone Medical Center
New York, New York, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
York Clinical Research, LLC
Norfolk, Virginia, United States
Instituto Medico DAMIC
Córdoba, , Argentina
Instituto Modelo de Gastroenterologia
Formosa, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
Austin Health
Melbourne, , Australia
Linear Clinical Research Ltd
Nedlands, , Australia
Medizinische Universitaet Graz
Graz, , Austria
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, , Belgium
University Hospital Ghent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire (CHU) de Liege
Liège, , Belgium
Robarts Research Institute
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Institute de Recherches Cliniques de Montreal
Montreal, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, Quebec, Canada
University Hospital Center Zagreb -Rebro, Department for Metabolic Diseases
Zagreb, , Croatia
AP-HM-Hopital de La Conception
Marseille, Cedez 05, France
AP-HP Hopital Pitie-Salpetriere
Paris, , France
Universitaetsklinikum Jena
Jena, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
University Hospital Galway
Galway, , Ireland
Hadassah Medical Center Ein Karem
Jerusalem, , Israel
Chiba University Hospital
Chiba, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Rinku General Medical Center
Osaka, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Tokyo University Hospital
Tokyo, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
National Institute of Medical Sciences and Nutrition - Salvador Zubiran (INCMNSZ)
Tlalpan, Mexico DF, Mexico
Instituto de Diabetes Obesidad y Nutrición S.C.
Cuernavaca, Morelos, Mexico
Centro Especializado en Diabetes Obesidad y Prevención de entermedades Cardiovasculares (CEDOPEC)
Mexico City, , Mexico
NZCR OPCO Ltd
Auckland, , New Zealand
Middlemore Clinical Trials
Auckland, , New Zealand
New Zealand Clinical Research
Christchurch, , New Zealand
Sultan Qaboos University Hospital
Muscat, , Oman
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Clinical Center of Serbia, Institute of Endocrinology, Diabetes and Metabolic Diseases
Belgrade, , Serbia
Clinical Centre Nis
Niš, , Serbia
National University Hospital
Singapore, , Singapore
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Abente y Lago
A Coruña, , Spain
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Erciyes University Faculty of Medicine
Melikgazi, Kayseri, Turkey (Türkiye)
Ege University Hospital Department Of Infectious Diseases
Izmir, , Turkey (Türkiye)
Countries
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References
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Watts GF, Rosenson RS, Hegele RA, Goldberg IJ, Gallo A, Mertens A, Baass A, Zhou R, Muhsin M, Hellawell J, Leeper NJ, Gaudet D; PALISADE Study Group. Plozasiran for Managing Persistent Chylomicronemia and Pancreatitis Risk. N Engl J Med. 2025 Jan 9;392(2):127-137. doi: 10.1056/NEJMoa2409368. Epub 2024 Sep 2.
Related Links
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Expanded access record
Other Identifiers
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AROAPOC3-3001
Identifier Type: -
Identifier Source: org_study_id
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