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Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Sponsor: Arrowhead Pharmaceuticals
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.
Official title: Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozsiran in Adults With Severe Hypertriglyceridemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
311
Start Date
2024-07-23
Completion Date
2026-09-10
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Plozasiran Injection
ARO-APOC3 Injection
Placebo
sterile normal saline (0.9% NaCl)
Locations (149)
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, Germany
Research Site 99
Békéscsaba, Hungary
Research Site 100
Kaposvár, Hungary