Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozsiran in Adults With Severe Hypertriglyceridemia
Status: Active_not_recruiting
Location: See all (142) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥500 mg/dL (≥5.65 mmol/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%
• 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)
Locations
United States
Alabama
Research Site 1
Birmingham
Research Site 2
Mobile
California
Research Site 3
Beverly Hills
Research Site 4
Canoga Park
Research Site 5
Huntington Beach
Research Site 6
Lincoln
Research Site 7
Long Beach
Research Site 8
Oxnard
Florida
Research Site 9
Clearwater
Research Site 10
North Miami
Research Site 11
Sarasota
Georgia
Research Site 12
Lawrenceville
Research Site 13
Sugar Hill
Indiana
Research Site 14
Elkhart
Research Site 15
Indianapolis
Research Site 16
South Bend
Kansas
Research Site 17
Overland Park
Research Site 18
Topeka
Louisiana
Research Site 19
Metairie
Maryland
Research Site 20
Annapolis
Mississippi
Research Site 21
Jackson
North Carolina
Research Site 28
Asheboro
Research Site 29
Wilmington
Nebraska
Research Site 22
Fremont
Research Site 23
Norfolk
New Jersey
Research Site 24
Morristown
New York
Research Site 26
New York
Research Site 27
Riverhead
Research Site 25
The Bronx
Ohio
Research Site 30
Beavercreek
Research Site 31
Columbus
Oklahoma
Research Site 32
Oklahoma City
Pennsylvania
Research Site 33
Horsham
Research Site 34
Newport
Research Site 35
Philadelphia
Research Site 36
Philadelphia
South Carolina
Research Site 37
Fort Mill
Research Site 38
Greenville
Tennessee
Research Site 39
Chattanooga
Texas
Research Site 40
Fort Worth
Research Site 41
Houston
Research Site 42
Houston
Research Site 43
Houston
Research Site 44
Sugar Land
Research Site 45
Tomball
Research Site 46
Victoria
Utah
Research Site 47
Bountiful
Research Site 48
St. George
Virginia
Research Site 49
Manassas
Research Site 50
Roanoke
Other Locations
Argentina
Research Site 52
Caba
Research Site 51
Ciudad Autónoma De Buenos Aires
Research Site 54
Córdoba
Research Site 53
Godoy Cruz
Research Site 55
Rosario
Brazil
Research Site 62
Aracaju
Research Site 59
Belo Horizonte
Research Site 56
Brasília
Research Site 57
Campinas
Research Site 63
Recife
Research Site 61
Salvador
Research Site 58
Santo André
Research Site 60
São José Do Rio Preto
Bulgaria
Research Site 64
Byala
Research Site 65
Dimitrovgrad
Research Site 66
Haskovo
Research Site 67
Kyustendil
Research Site 68
Rousse
Research Site 69
Sevlievo
Research Site 70
Sofia
Research Site 71
Sofia
Research Site 72
Sofia
Research Site 73
Sofia
Research Site 74
Sofia
Research Site 75
Sofia
Research Site 76
Sofia
Research Site 77
Stara Zagora
Canada
Research Site 79
Chicoutimi
Research Site 80
Laval
Research Site 78
North Vancouver
Research Site 81
Québec
Research Site 82
Terrebonne
France
Research Site 93
Bayonne
Research Site 94
Lyon
Research Site 91
Marseille
Research Site 90
Paris
Research Site 92
Pessac
Germany
Research Site 98
Berlin
Research Site 95
Deggingen
Research Site 97
Magdeburg
Research Site 96
Wallerfing
Hungary
Research Site 99
Békéscsaba
Research Site 100
Kaposvár
Research Site 101
Miskolc
Research Site 102
Pécs
Research Site 104
Pécs
Research Site 103
Zalaegerszeg
Latvia
Research Site 105
Daugavpils
Research Site 106
Daugavpils
Research Site 107
Daugavpils
Research Site 108
Kuldīga
Research Site 109
Riga
Research Site 110
Riga
Research Site 111
Riga
Research Site 112
Tukums
Lithuania
Research Site 113
Kaunas
Research Site 114
Kaunas
Research Site 115
Kaunas
Research Site 118
Šiauliai
Research Site 116
Vilnius
Research Site 117
Vilnius
New Zealand
Research Site 119
Christchurch
Research Site 120
New Plymouth
Research Site 121
Newtown
Poland
Research Site 122
Bydgoszcz
Research Site 123
Gdynia
Research Site 124
Katowice
Research Site 129
Lodz
Research Site 125
Malbork
Research Site 126
Szczecin
Research Site 130
Torun
Research Site 127
Wroclaw
Research Site 128
Zamość
Slovakia
Research Site 134
Bratislava
Research Site 131
Nové Zámky
Research Site 132
Prešov
Research Site 133
Rožňava
South Africa
Research Site 139
Cape Town
Research Site 140
Cape Town
Research Site 143
Cape Town
Research Site 144
Cape Town
Research Site 145
Cape Town
Research Site 135
Centurion
Research Site 138
Durban
Research Site 136
Krugersdorp
Research Site 146
Mossel Bay
Research Site 142
Plettenberg Bay
Research Site 137
Pretoria
Research Site 141
Somerset West
Spain
Research Site 149
A Coruña
Research Site 147
Madrid
Research Site 148
Seville
Time Frame
Start Date:2024-07-23
Completion Date:2026-09
Participants
Target number of participants:311
Treatments
Experimental: Plozasiran Injection
4 doses of plozasiran (ARO-APOC3) by subcutaneous (sc) injection
Placebo_comparator: Placebo
calculated volume to match active treatment by sc injection