Study of Plozasiran in Adults With Severe Hypertriglyceridemia
NCT ID: NCT06347016
Last Updated: 2025-10-24
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
311 participants
INTERVENTIONAL
2024-07-23
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
* 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%
* Must be on standard of care lipid-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 (except inclisiran, which is permitted)
* 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
* 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 Site 1
Birmingham, Alabama, United States
Research Site 2
Mobile, Alabama, United States
Research Site 3
Beverly Hills, California, United States
Research Site 4
Canoga Park, California, United States
Research Site 5
Huntington Beach, California, United States
Research Site 6
Lincoln, California, United States
Research Site 7
Long Beach, California, United States
Research Site 8
Oxnard, California, United States
Research Site 9
Clearwater, Florida, United States
Research Site 10
North Miami, Florida, United States
Research Site 11
Sarasota, Florida, United States
Research Site 12
Lawrenceville, Georgia, United States
Research Site 13
Sugar Hill, Georgia, United States
Research Site 14
Elkhart, Indiana, United States
Research Site 15
Indianapolis, Indiana, United States
Research Site 16
South Bend, Indiana, United States
Research Site 17
Overland Park, Kansas, United States
Research Site 18
Topeka, Kansas, United States
Research Site 19
Metairie, Louisiana, United States
Research Site 20
Annapolis, Maryland, United States
Research Site 21
Jackson, Mississippi, United States
Research Site 22
Fremont, Nebraska, United States
Research Site 23
Norfolk, Nebraska, United States
Research Site 24
Morristown, New Jersey, United States
Research Site 26
New York, New York, United States
Research Site 27
Riverhead, New York, United States
Research Site 25
The Bronx, New York, United States
Research Site 28
Asheboro, North Carolina, United States
Research Site 29
Wilmington, North Carolina, United States
Research Site 30
Beavercreek, Ohio, United States
Research Site 31
Columbus, Ohio, United States
Research Site 32
Oklahoma City, Oklahoma, United States
Research Site 33
Horsham, Pennsylvania, United States
Research Site 34
Newport, Pennsylvania, United States
Research Site 35
Philadelphia, Pennsylvania, United States
Research Site 36
Philadelphia, Pennsylvania, United States
Research Site 37
Fort Mill, South Carolina, United States
Research Site 38
Greenville, South Carolina, United States
Research Site 39
Chattanooga, Tennessee, United States
Research Site 40
Fort Worth, Texas, United States
Research Site 41
Houston, Texas, United States
Research Site 42
Houston, Texas, United States
Research Site 43
Houston, Texas, United States
Research Site 44
Sugar Land, Texas, United States
Research Site 45
Tomball, Texas, United States
Research Site 46
Victoria, Texas, United States
Research Site 47
Bountiful, Utah, United States
Research Site 48
St. George, Utah, United States
Research Site 49
Manassas, Virginia, United States
Research Site 50
Roanoke, Virginia, United States
Research Site 52
CABA, Buenos Aires, Argentina
Research Site 51
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Research Site 54
Córdoba, Córdoba Province, Argentina
Research Site 53
Godoy Cruz, Mendoza Province, Argentina
Research Site 55
Rosario, Santa Fe Province, Argentina
Research Site 61
Salvador, Estado de Bahia, Brazil
Research Site 56
Brasília, Federal District, Brazil
Research Site 59
Belo Horizonte, Minas Gerais, Brazil
Research Site 62
Aracaju, Sergipe, Brazil
Research Site 57
Campinas, São Paulo, Brazil
Research Site 58
Santo André, São Paulo, Brazil
Research Site 60
São José do Rio Preto, São Paulo, Brazil
Research Site 63
Recife, , Brazil
Research Site 64
Byala, , Bulgaria
Research Site 65
Dimitrovgrad, , Bulgaria
Research Site 66
Haskovo, , Bulgaria
Research Site 67
Kyustendil, , Bulgaria
Research Site 68
Rousse, , Bulgaria
Research Site 69
Sevlievo, , Bulgaria
Research Site 76
Sofia, , Bulgaria
Research Site 70
Sofia, , Bulgaria
Research Site 73
Sofia, , Bulgaria
Research Site 71
Sofia, , Bulgaria
Research Site 75
Sofia, , Bulgaria
Research Site 72
Sofia, , Bulgaria
Research Site 74
Sofia, , Bulgaria
Research Site 77
Stara Zagora, , Bulgaria
Research Site 78
North Vancouver, British Columbia, Canada
Research Site 79
Chicoutimi, Quebec, Canada
Research Site 80
Laval, Quebec, Canada
Research Site 81
Québec, Quebec, Canada
Research Site 82
Terrebonne, Quebec, Canada
Research Site 83
Brno, , Czechia
Research Site 84
Náchod, , Czechia
Research Site 85
Olomouc, , Czechia
Research Site 86
Prague, , Czechia
Research Site 88
Slaný, , Czechia
Research Site 89
Teplice, , Czechia
Research Site 87
Trutnov, , Czechia
Research Site 91
Marseille, Bouches-du-Rhône, France
Research Site 92
Pessac, Gironde, France
Research Site 93
Bayonne, Pyrenees Atlantiques, France
Research Site 94
Lyon, Rhone, France
Research Site 90
Paris, , France
Research Site 95
Deggingen, Baden-Wurttemberg, Germany
Research Site 96
Wallerfing, Bavaria, Germany
Research Site 97
Magdeburg, Saxony-Anhalt, Germany
Research Site 98
Berlin, State of Berlin, Germany
Research Site 99
Békéscsaba, , Hungary
Research Site 100
Kaposvár, , Hungary
Research Site 101
Miskolc, , Hungary
Research Site 102
Pécs, , Hungary
Research Site 104
Pécs, , Hungary
Research Site 103
Zalaegerszeg, , Hungary
Research Site 107
Daugavpils, , Latvia
Research Site 105
Daugavpils, , Latvia
Research Site 106
Daugavpils, , Latvia
Research Site 108
Kuldīga, , Latvia
Research Site 109
Riga, , Latvia
Research Site 110
Riga, , Latvia
Research Site 111
Riga, , Latvia
Research Site 112
Tukums, , Latvia
Research Site 115
Kaunas, , Lithuania
Research Site 113
Kaunas, , Lithuania
Research Site 114
Kaunas, , Lithuania
Research Site 118
Šiauliai, , Lithuania
Research Site 116
Vilnius, , Lithuania
Research Site 117
Vilnius, , Lithuania
Research Site 119
Christchurch, , New Zealand
Research Site 120
New Plymouth, , New Zealand
Research Site 121
Newtown, , New Zealand
Research Site 122
Bydgoszcz, , Poland
Research Site 123
Gdynia, , Poland
Research Site 124
Katowice, , Poland
Research Site 129
Lodz, , Poland
Research Site 125
Malbork, , Poland
Research Site 126
Szczecin, , Poland
Research Site 130
Torun, , Poland
Research Site 127
Wroclaw, , Poland
Research Site 128
Zamość, , Poland
Research Site 134
Bratislava, , Slovakia
Research Site 131
Nové Zámky, , Slovakia
Research Site 132
Prešov, , Slovakia
Research Site 133
Rožňava, , Slovakia
Research Site 135
Centurion, Gauteng, South Africa
Research Site 136
Krugersdorp, Gauteng, South Africa
Research Site 137
Pretoria, Gauteng, South Africa
Research Site 138
Durban, KwaZulu-Natal, South Africa
Research Site 144
Cape Town, Western Cape, South Africa
Research Site 139
Cape Town, Western Cape, South Africa
Research Site 140
Cape Town, Western Cape, South Africa
Research Site 143
Cape Town, Western Cape, South Africa
Research Site 145
Cape Town, Western Cape, South Africa
Research Site 146
Mossel Bay, Western Cape, South Africa
Research Site 142
Plettenberg Bay, Western Cape, South Africa
Research Site 141
Somerset West, Western Cape, South Africa
Research Site 149
A Coruña, La Coruña, Spain
Research Site 147
Madrid, , Spain
Research Site 148
Seville, , Spain
Countries
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Other Identifiers
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2023-509301-80
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AROAPOC3-3004
Identifier Type: -
Identifier Source: org_study_id
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