Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
NCT ID: NCT06347003
Last Updated: 2025-10-27
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
446 participants
INTERVENTIONAL
2024-07-22
2026-09-30
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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Plozasiran Injection
4 doses of plozasiran (ARO-APOC3) by subcutaneous (sc) injection
Plozasiran Injection
ARO-APOC3 Injection
Placebo
calculated volume to match active treatment by sc injection
Placebo
sterile normal saline (0.9% NaCl)
Interventions
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Plozasiran Injection
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
* Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L)
* Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
* Fasting low density lipoprotein-cholesterol (LDL-C) ≤130 mg/dL (≤3.37 mmol/L) at screening
* Screening HbA1C ≤9.0%
* Willing to follow diet counseling and maintain a stable low-fat diet
* Must be on standard of care lipid and TG lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug)
Exclusion Criteria
* Use of any other hepatocyte-targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer
* Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes
* Acute pancreatitis within 4 weeks prior to screening
* Body mass index \>45kg/m\^2
18 Years
ALL
No
Sponsors
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Arrowhead Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Research Center 1
Garden Grove, California, United States
Research Center 2
Lake Forest, California, United States
Research Center 3
Montclair, California, United States
Research Center 4
Panorama City, California, United States
Research Center 5
Redding, California, United States
Research Center 6
Colorado Springs, Colorado, United States
Research Center 7
Hialeah, Florida, United States
Research Center 8
Lake City, Florida, United States
Research Center 9
Miami Lakes, Florida, United States
Research Center 10
Mt. Dora, Florida, United States
Research Center 11
Orlando, Florida, United States
Research Center 12
Pensacola, Florida, United States
Research Center 13
Tamarac, Florida, United States
Research Center 14
Tampa, Florida, United States
Research Center 15
Macon, Georgia, United States
Research Center 16
Savannah, Georgia, United States
Research Center 17
Park Ridge, Illinois, United States
Research Center 18
Eunice, Louisiana, United States
Research Center 19
Baltimore, Maryland, United States
Research Center 20
Flint, Michigan, United States
Research Center 21
Minneapolis, Minnesota, United States
Research Center 22
Olive Branch, Mississippi, United States
Research Center 23
Jefferson City, Missouri, United States
Research Center 24
St Louis, Missouri, United States
Research Center 26
Omaha, Nebraska, United States
Research Center 25
Omaha, Nebraska, United States
Research Center 27
Las Vegas, Nevada, United States
Research Center 29
Long Island City, New York, United States
Research Center 30
New York, New York, United States
Research Center 31
Rochester, New York, United States
Research Center 28
The Bronx, New York, United States
Research Center 32
Vestal, New York, United States
Research Center 33
Morehead City, North Carolina, United States
Research Center 34
Winston-Salem, North Carolina, United States
Research Center 35
Cincinnati, Ohio, United States
Research Center 36
Columbus, Ohio, United States
Research Center 37
Norman, Oklahoma, United States
Research Center 38
Oklahoma City, Oklahoma, United States
Research Center 39
Powell, Tennessee, United States
Research Center 40
El Paso, Texas, United States
Research Center 47
Houston, Texas, United States
Research Center 45
Houston, Texas, United States
Research Center 46
Houston, Texas, United States
Research Center 42
Houston, Texas, United States
Research Center 44
Houston, Texas, United States
Research Center 43
Houston, Texas, United States
Research Center 41
Houston, Texas, United States
Research Center 48
Laredo, Texas, United States
Research Center 49
Missouri City, Texas, United States
Research Center 50
Plano, Texas, United States
Research Center 51
San Antonio, Texas, United States
Research Center 52
Seattle, Washington, United States
Research Center 8
Ramos Mejía, Buenos Aires, Argentina
Research Center 10
San Isidro, Buenos Aires, Argentina
Research Center 7
Temperley, Buenos Aires, Argentina
Research Center 4
Córdoba, Córdoba Province, Argentina
Research Center 9
Córdoba, Córdoba Province, Argentina
Research Center 5
Córdoba, Córdoba Province, Argentina
Research Center 3
Córdoba, Córdoba Province, Argentina
Research Center 6
Buenos Aires, , Argentina
Research Center 2
Buenos Aires, , Argentina
Research Center 1
Buenos Aires, , Argentina
Research Center 1
Blacktown, New South Wales, Australia
Research Center 4
Concord, New South Wales, Australia
Research Center 5
Merewether, New South Wales, Australia
Research Center 2
Box Hill, Victoria, Australia
Research Center 7
Clayton, Victoria, Australia
Research Center 3
Heidelberg, Victoria, Australia
Research Center 6
Crawley, Western Australia, Australia
Research Center 4
Gozée, , Belgium
Research Center 6
Hasselt, , Belgium
Research Center 3
Mechelen, , Belgium
Research Center 2
Namur, , Belgium
Research Center 5
Roeselare, , Belgium
Research Center 1
Wetteren, , Belgium
Research Center 10
Vitória, Espírito Santo, Brazil
Research Center 12
Salvador, Estado de Bahia, Brazil
Research Center 13
Salvador, Estado de Bahia, Brazil
Research Center 14
Salvador, Estado de Bahia, Brazil
Research Center 5
Belo Horizonte, Minas Gerais, Brazil
Research Center 8
Campina Grande do Sul, Paraná, Brazil
Research Center 2
Curitiba, Paraná, Brazil
Research Center 4
Belém, Pará, Brazil
Research Center 6
Porto Alegre, Rio Grande do Sul, Brazil
Research Center 9
Porto Alegre, Rio Grande do Sul, Brazil
Research Center 1
Campinas, São Paulo, Brazil
Research Center 7
São Paulo, São Paulo, Brazil
Research Center 11
São Paulo, São Paulo, Brazil
Research Center 3
Votuporanga, São Paulo, Brazil
Research Center 8
Burgas, Burgas, Bulgaria
Research Center 11
Rousse, Ruse, Bulgaria
Research Center 15
Sofia, Sofia, Bulgaria
Research Center 7
Sofia, Sofia, Bulgaria
Research Center 12
Blagoevgrad, , Bulgaria
Research Center 10
Kardzhali, , Bulgaria
Research Center 1
Pleven, , Bulgaria
Research Center 3
Pleven, , Bulgaria
Research Center 4
Plovdiv, , Bulgaria
Research Center 2
Plovdiv, , Bulgaria
Research Center 9
Plovdiv, , Bulgaria
Research Center 13
Sofia, , Bulgaria
Research Center 6
Sofia, , Bulgaria
Research Center 5
Sofia, , Bulgaria
Research Center 14
Sofia, , Bulgaria
Research Center 3
Victoria, British Columbia, Canada
Research Center 1
Brampton, Ontario, Canada
Research Center 8
London, Ontario, Canada
Research Center 2
Sarnia, Ontario, Canada
Research Center 5
Waterloo, Ontario, Canada
Research Center 6
Montreal, Quebec, Canada
Research Center 4
Québec, Quebec, Canada
Research Center 7
Halifax, , Canada
Research Center 11
Bengbu, Anhui, China
Research Center 23
Beijing, Beijing Municipality, China
Research Center 22
Beijing, Beijing Municipality, China
Research Center 7
Guangzhou, Guangdong, China
Research Center 19
Guanzhou, Guangdong, China
Research Center 8
Liuzhou, Guangxi Zhuang, China
Research Center 13
Xingtai, Hebei, China
Research Center 6
Luoyang, Henan, China
Research Center 21
Wuhan, Hubei, China
Research Center 4
Changsha, Hunan, China
Research Center 18
Changsha, Hunan, China
Research Center 16
Baotou, Inner Mongolia, China
Research Center 10
Suzhou, Jiangsu, China
Research Center 9
Shanghai, Shanghai Municipality, China
Research Center 12
Shanghai, Shanghai Municipality, China
Research Center 2
Yuncheng, Shanxi, China
Research Center 17
Chengdu, Sichuan, China
Research Center 20
Tianjin, Tianjin Municipality, China
Research Center 1
Beijing, Xicheng, China
Research Center 15
Wenzhou, Zhejiang, China
Research Center 5
Hangzhou, , China
Research Center 3
Liaocheng, , China
Research Center 14
Nanchang, , China
Research Center 1
Zagreb, City of Zagreb, Croatia
Research Center 2
Krapinske Toplice, , Croatia
Research Center 3
Zagreb, , Croatia
Research Center 4
Zagreb, , Croatia
Research Center 8
Prague, Prague, Czechia
Research Center 4
Prague, Prague, Czechia
Research Center 3
Hodonín, , Czechia
Research Center 6
Hradec Králové, , Czechia
Research Center 1
Ostrava, , Czechia
Research Center 7
Praha 1-Nove Mesto, , Czechia
Research Center 5
Praha 4-Krc, , Czechia
Research Center 2
Uherské Hradiště, , Czechia
Research Center 9
Ústí nad Labem, , Czechia
Research Center 1
Budapest, , Hungary
Research Center 4
Budapest, , Hungary
Research Center 2
Budapest, , Hungary
Research Center 6
Budapest, , Hungary
Research Center 3
Szeged, , Hungary
Research Center 5
Veszprém, , Hungary
Research Center 3
Rozzano, Milano, Italy
Research Center 2
Palermo, Sicily, Italy
Research Center 6
Bologna, , Italy
Research Center 5
Brescia, , Italy
Research Center 4
Milan, , Italy
Research Center 1
Roma, , Italy
Research Center 15
Żarów, Swidnica, Poland
Research Center 7
Bydgoszcz, , Poland
Research Center 11
Elblag, , Poland
Research Center 10
Katowice, , Poland
Research Center 13
Krakow, , Poland
Research Center 17
Krakow, , Poland
Research Center 8
Krakow, , Poland
Research Center 12
Lodz, , Poland
Research Center 18
Warsaw, , Poland
Research Center 9
Warsaw, , Poland
Research Center 16
Wroclaw, , Poland
Research Center 14
Wroclaw, , Poland
Research Center 3
Brasov, Brașov County, Romania
Research Center 1
Bucharest, București, Romania
Research Center 2
Cluj-Napoca, Cluj, Romania
Research Center 6
Alba Iulia, Jud. Alba, Romania
Research Center 4
Ploieşti, Jud. Prahova, Romania
Research Center 5
Timișoara, Timiș County, Romania
Research Center 8
Deva, , Romania
Research Center 7
Galati, , Romania
Research Center 9
Târgu Mureş, , Romania
Research Center 4
Banská Bystrica, Banská Bystrica Region, Slovakia
Research Center 1
Košice, Košice Region, Slovakia
Research Center 3
Moldava nad Bodvou, Košice Region, Slovakia
Research Center 6
Bardejov, , Slovakia
Research Center 5
Bratislava, , Slovakia
Research Center 2
Žilina, Žilina Region, Slovakia
Research Center 2
Barcelona, , Spain
Research Center 3
Barcelona, , Spain
Research Center 1
Valencia, , Spain
Research Center 4
Zaragoza, , Spain
Research Center 3
Torpoint, Cornwall, United Kingdom
Research Center 5
Torquay, Devon, United Kingdom
Research Center 2
Plymouth, Devpn, United Kingdom
Research Center 1
London, , United Kingdom
Research Center 4
London, , United Kingdom
Countries
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Other Identifiers
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2023-509300-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AROAPOC3-3003
Identifier Type: -
Identifier Source: org_study_id
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