Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Hypertriglyceridemia

Status: Active_not_recruiting
Location: See all (221) 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 hypertriglyceridemia (HTG). 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening

• Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)

• Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 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 a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels.

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
Garden Grove
Research Site 6
Huntington Beach
Research Site 7
Lake Forest
Research Site 8
Lincoln
Research Site 9
Long Beach
Research Site 10
Montclair
Research Site 11
Oxnard
Research Site 12
Redding
Research Site 13
Van Nuys
Colorado
Research Site 14
Colorado Springs
Florida
Research Site 15
Clearwater
Research Site 16
Hialeah
Research Site 17
Lake City
Research Site 18
Miami Lakes
Research Site 19
Mt. Dora
Research Site 20
North Miami Beach
Research Site 21
Orlando
Research Site 22
Pensacola
Research Site 23
Sarasota
Research Site 24
Tamarac
Georgia
Research Site 25
Lawrenceville
Research Site 26
Macon
Research Site 27
Savannah
Research Site 28
Sugar Hill
Illinois
Research Site 29
Park Ridge
Indiana
Research Site 30
Elkhart
Research Site 31
Indianapolis
Research Site 32
South Bend
Kansas
Research Site 33
Overland Park
Research Site 34
Topeka
Kentucky
Research Site 35
Louisville
Louisiana
Research Site 36
Zachary
Maryland
Research Site 37
Annapolis
Research Site 38
Baltimore
Michigan
Research Site 39
Flint
Minnesota
Research Site 40
Minneapolis
Missouri
Research Site 42
Jefferson City
Research Site 43
St Louis
Mississippi
Research Site 41
Olive Branch
North Carolina
Research Site 56
Asheboro
Research Site 57
Morehead City
Research Site 58
Wilmington
Research Site 59
Winston-salem
Nebraska
Research Site 44
Norfolk
Research Site 45
Omaha
Research Site 46
Omaha
New Jersey
Research Site 48
Summit
Nevada
Research Site 47
Las Vegas
New York
Research Site 51
New York
Research Site 52
New York
Research Site 53
Riverhead
Research Site 54
Rochester
Research Site 49
The Bronx
Research Site 50
The Bronx
Research Site 55
Vestal
Ohio
Research Site 60
Beavercreek
Research Site 61
Cincinnati
Research Site 62
Columbus
Research Site 63
Columbus
Oklahoma
Research Site 64
Norman
Research Site 65
Oklahoma City
Research Site 66
Oklahoma City
Pennsylvania
Research Site 67
Horsham
Research Site 68
Newport
Research Site 69
Newport
Research Site 70
Philadelphia
Research Site 71
Wilkes-barre
South Carolina
Research Site 72
Fort Mill
Research Site 73
Greenville
Tennessee
Research Site 74
Chattanooga
Research Site 75
Powell
Texas
Research Site 76
El Paso
Research Site 77
Fort Worth
Research Site 78
Houston
Research Site 79
Houston
Research Site 80
Houston
Research Site 81
Houston
Research Site 82
Houston
Research Site 83
Houston
Research Site 84
Houston
Research Site 85
Houston
Research Site 86
Houston
Research Site 87
Laredo
Research Site 88
Missouri City
Research Site 89
Plano
Research Site 90
San Antonio
Research Site 91
Sugar Land
Research Site 92
Tomball
Research Site 93
Victoria
Utah
Research Site 94
Bountiful
Research Site 95
St. George
Virginia
Research Site 96
Manassas
Washington
Research Site 97
Seattle
Other Locations
Argentina
Research Site 100
Caba
Research Site 102
Caba
Research Site 103
Ciudad Autonoma Buenos Aires
Research Site 104
Córdoba
Research Site 106
Córdoba
Research Site 98
Córdoba
Research Site 101
Godoy Cruz
Research Site 105
Rosario
Research Site 99
Rosario
Australia
Research Site 107
Blacktown
Research Site 110
Clayton
Research Site 109
Heidelberg Heights
Research Site 108
Merewether
Bulgaria
Research Site 111
Blagoevgrad
Research Site 112
Burgas
Research Site 113
Byala
Research Site 114
Dimitrovgrad
Research Site 115
Haskovo
Research Site 116
Kyustendil
Research Site 117
Pleven
Research Site 118
Pleven
Research Site 119
Plovdiv
Research Site 120
Plovdiv
Research Site 121
Plovdiv
Research Site 122
Rousse
Research Site 123
Sevlievo
Research Site 124
Sofia
Research Site 125
Sofia
Research Site 126
Sofia
Research Site 127
Sofia
Research Site 128
Sofia
Research Site 129
Sofia
Research Site 130
Sofia
Research Site 131
Sofia
Research Site 132
Sofia
Research Site 133
Sofia
Research Site 134
Sofia
Research Site 135
Sofia
Research Site 137
Sofia
Research Site 136
Stara Zagora
Canada
Research Site 142
Brampton
Research Site 145
Chicoutimi
Research Site 138
Halifax
Research Site 146
Laval
Research Site 149
Montreal
Research Site 140
North Vancouver
Research Site 139
Québec
Research Site 147
Québec
Research Site 148
Québec
Research Site 143
Sarnia
Research Site 141
Victoria
Research Site 144
Waterloo
France
Research Site 166
Lyon
Research Site 164
Marseille
Research Site165
Paris
Research Site 167
Pessac
Germany
Research Site 170
Deggingen
Research Site 168
Magdeburg
Research Site 169
Wallerfing
Hungary
Research Site 171
Békéscsaba
Research Site 175
Budapest
Research Site 179
Budapest
Research Site 180
Budapest
Research Site 183
Budapest
Research Site 184
Budapest
Research Site 182
Kaposvár
Research Site 176
Miskolc
Research Site 172
Pécs
Research Site 177
Pécs
Research Site 178
Szeged
Research Site 173
Veszprém
Research Site 174
Zalaegerszeg
Italy
Research Site 189
Bologna
Research Site 185
Brescia
Research Site 188
Milan
Research Site 187
Palermo
Research Site 186
Rozzano
Poland
Research Site 200
Bydgoszcz
Research Site 202
Bydgoszcz
Research Site 192
Elblag
Research Site 193
Gdynia
Research Site 190
Katowice
Research Site 197
Krakow
Research Site 204
Krakow
Research Site 191
Lodz
Research Site 201
Lodz
Research Site 194
Malbork
Research Site 199
Szczecin
Research Site 207
Torun
Research Site 198
Warsaw
Research Site 205
Warsaw
Research Site 196
Wroclaw
Research Site 206
Wroclaw
Research Site 208
Wroclaw
Research Site 195
Zamość
Research Site 203
Żarów
Slovakia
Research Site 214
Banská Bystrica
Research Site 212
Bardejov
Research Site 216
Bratislava
Research Site 217
Bratislava
Research Site 210
Košice
Research Site 213
Moldava Nad Bodvou
Research Site 209
Nové Zámky
Research Site 211
Prešov
Research Site 215
Rožňava
Research Site 218
Žilina
South Africa
Research Site 219
Cape Town
Research Site 223
Cape Town
Research Site 225
Cape Town
Research Site 227
Cape Town
Research Site 221
Centurion
Research Site 224
Durban
Research Site 222
Krugersdorp
Research Site 226
Pretoria
Research Site 228
Pretoria
Research Site 220
Somerset West
Spain
Research Site 229
A Coruña
Research Site 230
Barcelona
Research Site 234
Barcelona
Research Site 232
Madrid
Research Site 231
Valencia
Research Site 233
Zaragoza
United Kingdom
Research Site 235
London
Research Site 236
Plymouth
Time Frame
Start Date: 2024-05-21
Completion Date: 2026-09
Participants
Target number of participants: 1456
Treatments
Experimental: Plozasiran Injection
4 doses of plozasiran by subcutaneous (sc) injection
Placebo_comparator: Placebo
calculated volume to match active treatment by sc injection
Sponsors
Leads: Arrowhead Pharmaceuticals

This content was sourced from clinicaltrials.gov