Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10)

A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10 Study)

This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133).

Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of <=10% within 30 days prior to Day 1.

Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria:

1. HbA1c ≤10% within 30 days prior to Day 1
2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d)
3. Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001
4. Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001

All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.

Study Overview

• Status: Recruiting
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Drug: Plozasiran Injection

• Study Type: Interventional
• Enrollment (Estimated): 869
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Medical Monitor; Phone Number: 626-304-3400; Email: plozasiran@arrowheadpharma.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1056ABI
    • Active, not recruiting
    • Research Site 277
  • Ciudad Autonoma Buenos Aires, Argentina, 1425
    • Active, not recruiting
    • Research Site 172
  • Ciudad Autonoma Buenos Aires, Argentina, C1417
    • Active, not recruiting
    • Research Site 276
  • Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
    • Active, not recruiting
    • Research Site 173
  • Córdoba, Argentina, 5000
    • Active, not recruiting
    • Research Site 278
  • Córdoba, Argentina, X5000AAW
    • Active, not recruiting
    • Research Site 171
  • Córdoba, Argentina, X5006CBI
    • Active, not recruiting
    • Research Site 239
  • Córdoba, Argentina, X5008HHW
    • Active, not recruiting
    • Research Site 240
  • Rosario, Argentina, 2000
    • Active, not recruiting
    • Research Site 249
  • Buenos Aires
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1128AAF
      • Active, not recruiting
      • Research Site 250
    • Ramos Mejía, Buenos Aires, Argentina, B1704ETD
      • Active, not recruiting
      • Research Site 251
• Australia
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Active, not recruiting
      • Research Site 86
    • Clayton, Victoria, Australia, 3168
      • Active, not recruiting
      • Research Site 253
    • Heidelberg Heights, Victoria, Australia, 3081
      • Active, not recruiting
      • Research Site 252
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Research Site 174
• Belgium
  • Gozée, Belgium, 6534
    • Active, not recruiting
    • Research Site 48
  • Hasselt, Belgium, 3500
    • Active, not recruiting
    • Research Site 87
  • Mechelen, Belgium, 97770
    • Active, not recruiting
    • Research Site 90
  • Namur, Belgium, 5000
    • Active, not recruiting
    • Research Site 46
  • Namur, Belgium, 5380
    • Active, not recruiting
    • Research Site 89
  • Roeselare, Belgium, 8800
    • Active, not recruiting
    • Research Site 175
  • Wetteren, Belgium, 9230
    • Active, not recruiting
    • Research Site 45
• Brazil
  • Campina Grande do Sul, Brazil, 83430-000
    • Active, not recruiting
    • Research Site 279
  • Paranã, Brazil, 80730-150
    • Active, not recruiting
    • Research Site 296
  • Salvador, Brazil, 40170310
    • Active, not recruiting
    • Research Site 281
  • Salvador, Brazil, 40323-010
    • Active, not recruiting
    • Research Site 280
  • São Paulo, Brazil, 04266-010
    • Active, not recruiting
    • Research Site 177
  • São Paulo, Brazil, 05403-900
    • Active, not recruiting
    • Research Site 179
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41810-010
      • Active, not recruiting
      • Research Site 259
  • Federal District
    • Brasília, Federal District, Brazil, 70710-100
      • Active, not recruiting
      • Research Site 257
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-274
      • Active, not recruiting
      • Research Site 178
    • Belo Horizonte, Minas Gerais, Brazil, 30220-140
      • Active, not recruiting
      • Research Site 255
  • Pará
    • Belém, Pará, Brazil, 66073-000
      • Recruiting
      • Research Site 254
  • Rio Grande do Sul
    • Canoas, Rio Grande do Sul, Brazil, 92425-900
      • Active, not recruiting
      • Research Site 256
    • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
      • Recruiting
      • Research Site 258
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49055-530
      • Active, not recruiting
      • Research Site 181
  • São Paulo
    • Campinas, São Paulo, Brazil, 13060-080
      • Active, not recruiting
      • Research Site 180
    • Votuporanga, São Paulo, Brazil, 15500-269
      • Active, not recruiting
      • Research Site 176
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Active, not recruiting
    • Research Site 187
  • Dimitrovgrad, Bulgaria, 6400
    • Active, not recruiting
    • Research Site 100
  • Kardzhali, Bulgaria, 6600
    • Active, not recruiting
    • Research Site 98
  • Kyustendil, Bulgaria, 2500
    • Active, not recruiting
    • Research Site 52
  • Pleven, Bulgaria, 5800
    • Active, not recruiting
    • Research Site 49
  • Plovdiv, Bulgaria, 4001
    • Active, not recruiting
    • Research Site 185
  • Plovdiv, Bulgaria, 4002
    • Active, not recruiting
    • Research Site 50
  • Rousse, Bulgaria, 7013
    • Active, not recruiting
    • Research Site 94
  • Sofia, Bulgaria, 1404
    • Recruiting
    • Research Site 53
  • Sofia, Bulgaria, 1431
    • Active, not recruiting
    • Research Site 182
  • Sofia, Bulgaria, 1431
    • Active, not recruiting
    • Research Site 186
  • Sofia, Bulgaria, 1510
    • Active, not recruiting
    • Research Site 282
  • Sofia, Bulgaria, 1527
    • Active, not recruiting
    • Research Site 184
  • Sofia, Bulgaria, 1582
    • Active, not recruiting
    • Research Site 260
  • Sofia, Bulgaria, 1616
    • Active, not recruiting
    • Research Site 51
  • Sofia, Bulgaria, 1618
    • Active, not recruiting
    • Research Site 97
  • Sofia, Bulgaria, 1756
    • Active, not recruiting
    • Research Site 283
  • Stara Zagora, Bulgaria, 6010
    • Active, not recruiting
    • Research Site 99
• Canada
  • Kitchener, Canada, N2H5Z8
    • Recruiting
    • Research Site 56
  • Québec, Canada, G1G5X1
    • Active, not recruiting
    • Research Site 19
  • British Columbia
    • Victoria, British Columbia, Canada, V8T5G4
      • Active, not recruiting
      • Research Site 20
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, NS B3H 1V7
      • Active, not recruiting
      • Research Site 103
  • Ontario
    • London, Ontario, Canada, N6A 5K8
      • Recruiting
      • Research Site 7
    • Sarnia, Ontario, Canada, N7T 4X3
      • Active, not recruiting
      • Research Site 55
    • Toronto, Ontario, Canada, M5G 2C4
      • Active, not recruiting
      • Research Site 241
    • Waterloo, Ontario, Canada, N2T 0C1
      • Active, not recruiting
      • Research Site 102
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Active, not recruiting
      • Research Site 6
    • Montreal, Quebec, Canada, H2W 1R7
      • Active, not recruiting
      • Research Site 5
    • Québec, Quebec, Canada, G1V 4W2
      • Active, not recruiting
      • Research Site 4
• China
  • Beijing, China, 100730
    • Active, not recruiting
    • Research Site 295
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Active, not recruiting
      • Research Site 191
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Active, not recruiting
      • Research Site 104
    • Beijing, Beijing Municipality, China, 100091
      • Active, not recruiting
      • Research Site 193
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Research Site 62
    • Guangzhou, Guangdong, China, 510180
      • Active, not recruiting
      • Research Site 111
  • Guangxi Zhuang
    • Liuzhou, Guangxi Zhuang, China, 545006
      • Active, not recruiting
      • Research Site 63
  • Hebei
    • Xingtai, Hebei, China, 054099
      • Active, not recruiting
      • Research Site 106
  • Henan
    • Luoyang, Henan, China, 471003
      • Active, not recruiting
      • Research Site 188
  • Hu'nan
    • Changsha, Hu'nan, China, 410011
      • Active, not recruiting
      • Research Site 59
    • Changsha, Hu'nan, China, 410015
      • Active, not recruiting
      • Research Site 108
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Active, not recruiting
      • Research Site 261
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • Active, not recruiting
      • Research Site 115
  • Jiangsu
    • Suzhou, Jiangsu, China, 215002
      • Active, not recruiting
      • Research Site 192
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Active, not recruiting
      • Research Site 61
  • Shandong
    • Liaocheng, Shandong, China, 252000
      • Active, not recruiting
      • Research Site 190
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Active, not recruiting
      • Research Site 243
    • Shanghai, Shanghai Municipality, China, 200050
      • Active, not recruiting
      • Research Site 189
  • Shanxi
    • Yuncheng, Shanxi, China, 44000
      • Active, not recruiting
      • Research Site 105
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Active, not recruiting
      • Research Site 113
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300121
      • Active, not recruiting
      • Research Site 242
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Active, not recruiting
      • Research Site 60
• Croatia
  • Karlovac, Croatia, 47000
    • Active, not recruiting
    • Research Site 262
  • Zagreb, Croatia, 10000
    • Active, not recruiting
    • Research Site 194
• Czechia
  • Hodonín, Czechia, 69501
    • Active, not recruiting
    • Research Site 65
  • Hradec Králové, Czechia, 50005
    • Active, not recruiting
    • Research Site 197
  • Náchod, Czechia, 547 01
    • Active, not recruiting
    • Research Site 264
  • Olomouc, Czechia, CZ77900
    • Active, not recruiting
    • Research Site 118
  • Prague, Czechia, 11000
    • Active, not recruiting
    • Research Site 119
  • Prague, Czechia, 11000
    • Active, not recruiting
    • Research Site 66
  • Prague, Czechia, 140 21
    • Active, not recruiting
    • Research Site 244
  • Praha 4-Krc, Czechia, 140 59
    • Active, not recruiting
    • Research Site 116
  • Slaný, Czechia, 27401
    • Active, not recruiting
    • Research Site 263
  • Teplice, Czechia, 41501
    • Active, not recruiting
    • Research Site 198
  • Trutnov, Czechia, 541 01
    • Active, not recruiting
    • Research Site 196
  • Ústí nad Labem, Czechia, 40113
    • Active, not recruiting
    • Research Site 195
• France
  • Bouches-du-Rhône
    • Marseille, Bouches-du-Rhône, France, 13005
      • Active, not recruiting
      • Research Site 199
  • Gironde
    • Pessac, Gironde, France, 33604
      • Active, not recruiting
      • Research Site 120
  • Paris
    • Paris, Paris, France, 75013
      • Active, not recruiting
      • Research Site 200
• Germany
  • Berlin, Germany, 13353
    • Active, not recruiting
    • Research Site 285
  • Deggingen, Germany, 73326
    • Active, not recruiting
    • Research Site 284
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39120
      • Active, not recruiting
      • Research Site 201
• Hungary
  • Budapest, Hungary, 1033
    • Active, not recruiting
    • Research Site 204
  • Budapest, Hungary, 1051
    • Active, not recruiting
    • Research Site 123
  • Budapest, Hungary, 1132
    • Active, not recruiting
    • Research Site 68
  • Budapest, Hungary, 1152
    • Active, not recruiting
    • Research Site 265
  • Miskolc, Hungary, 3530
    • Active, not recruiting
    • Research Site 205
  • Pécs, Hungary, 7623
    • Active, not recruiting
    • Research Site 67
  • Szeged, Hungary, 6725
    • Active, not recruiting
    • Research Site 286
  • Veszprém, Hungary, 8200
    • Active, not recruiting
    • Research Site 202
  • Zalaegerszeg, Hungary, 8900
    • Active, not recruiting
    • Research Site 203
• Italy
  • Bologna, Italy, 40138
    • Active, not recruiting
    • Research Site 245
  • Brescia, Italy, 25123
    • Active, not recruiting
    • Research Site 208
  • Milan, Italy, 20162
    • Active, not recruiting
    • Research Site 207
  • Palermo, Italy, 90127
    • Active, not recruiting
    • Research Site 210
  • Roma, Italy, 00168
    • Active, not recruiting
    • Research Site 206
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Active, not recruiting
      • Research Site 209
• Latvia
  • Daugavpils, Latvia, LV-5410
    • Active, not recruiting
    • Research Site 212
  • Daugavpils, Latvia, LV-5417
    • Active, not recruiting
    • Research Site 124
  • Riga, Latvia, LV-1002
    • Active, not recruiting
    • Research Site 211
  • Riga, Latvia, LV-1038
    • Active, not recruiting
    • Research Site 287
  • Riga, Latvia, LV1063
    • Active, not recruiting
    • Research Site 69
• Lithuania
  • Kaunas, Lithuania, 49387
    • Active, not recruiting
    • Research Site 70
  • Kaunas, Lithuania, 49449
    • Active, not recruiting
    • Research Site 246
  • Kaunas, Lithuania, LT-50177
    • Active, not recruiting
    • Research Site 213
  • Vilnius, Lithuania, LT-08661
    • Active, not recruiting
    • Research Site 214
  • Šiauliai, Lithuania, LT-76206
    • Active, not recruiting
    • Research Site 127
• New Zealand
  • Christchurch, New Zealand, 08011
    • Active, not recruiting
    • Research Site 128
  • Wellington, New Zealand, 6021
    • Active, not recruiting
    • Research Site 129
• Poland
  • Elblag, Poland, 82-300
    • Active, not recruiting
    • Research Site 78
  • Gdynia, Poland, 81-338
    • Active, not recruiting
    • Research Site 247
  • Katowice, Poland, 40-156
    • Active, not recruiting
    • Research Site 81
  • Katowice, Poland, 40-752
    • Active, not recruiting
    • Research Site 141
  • Katowice, Poland, 40-752
    • Active, not recruiting
    • Research Site 85
  • Krakow, Poland, 31-501
    • Active, not recruiting
    • Research Site 83
  • Lodz, Poland, 91-363
    • Active, not recruiting
    • Research Site 136
  • Lodz, Poland, 94-255
    • Active, not recruiting
    • Research Site 131
  • Lodz, Poland, 94-255
    • Active, not recruiting
    • Research Site 79
  • Malbork, Poland, 82-200
    • Active, not recruiting
    • Research Site 80
  • Szczecin, Poland, 71- 500
    • Active, not recruiting
    • Research Site 135
  • Warsaw, Poland, 00-215
    • Active, not recruiting
    • Research Site 84
  • Warsaw, Poland, 03-291
    • Active, not recruiting
    • Research Site 216
  • Wroclaw, Poland, 51-314
    • Withdrawn
    • Research Site 133
  • Wroclaw, Poland, 53-030
    • Active, not recruiting
    • Research Site 267
  • Wroclaw, Poland, 53-673
    • Withdrawn
    • Research Site 140
  • Zamość, Poland, 22-400
    • Active, not recruiting
    • Research Site 215
  • Żarów, Poland, 58-130
    • Active, not recruiting
    • Research Site 82
• Romania
  • Bucharest, Romania, 010192
    • Active, not recruiting
    • Research Site 142
  • Galati, Romania, 800291
    • Active, not recruiting
    • Research Site 217
  • Ploieşti, Romania, 100342
    • Active, not recruiting
    • Research Site 143
  • Timișoara, Romania, 300362
    • Active, not recruiting
    • Research Site 145
  • Târgu Mureş, Romania, 540136
    • Active, not recruiting
    • Research Site 144
• Slovakia
  • Banská Bystrica, Slovakia, 97401
    • Active, not recruiting
    • Research Site 268
  • Bardejov, Slovakia, 08501
    • Active, not recruiting
    • Research Site 147
  • Košice, Slovakia, 04001
    • Active, not recruiting
    • Research Site 146
  • Moldava nad Bodvou, Slovakia, 045 01
    • Active, not recruiting
    • Research Site 218
  • Nitra, Slovakia, 950 01
    • Active, not recruiting
    • Research Site 248
  • Rožňava, Slovakia, 048 01
    • Active, not recruiting
    • Research Site 148
• South Africa
  • Cape Town, South Africa, 7530
    • Active, not recruiting
    • Research Site 288
  • Gauteng
    • Krugersdorp, Gauteng, South Africa, 1739
      • Active, not recruiting
      • Research Site 219
    • Pretoria, Gauteng, South Africa, 0181
      • Active, not recruiting
      • Research Site 270
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7570
      • Recruiting
      • Research Site 220
    • Cape Town, Western Cape, South Africa, 7500
      • Active, not recruiting
      • Research Site 222
    • Cape Town, Western Cape, South Africa, 7925
      • Active, not recruiting
      • Research Site 221
    • Mossel Bay, Western Cape, South Africa, 6500
      • Active, not recruiting
      • Research Site 269
    • Somerset West, Western Cape, South Africa, 7130
      • Active, not recruiting
      • Research Site 149
• Spain
  • Barcelona, Spain, 08023
    • Active, not recruiting
    • Research Site 271
  • Barcelona, Spain, 08035
    • Active, not recruiting
    • Research Site 223
  • Madrid, Spain, 28041
    • Active, not recruiting
    • Research Site 226
  • Santiago de Compostela, Spain, 15706
    • Active, not recruiting
    • Research Site 289
  • Seville, Spain, 41013
    • Active, not recruiting
    • Research Site 150
  • Valencia, Spain, 46010
    • Active, not recruiting
    • Research Site 225
  • Zaragoza, Spain, 50009
    • Active, not recruiting
    • Research Site 151
  • La Coruña
    • A Coruña, La Coruña, Spain, 15006
      • Recruiting
      • Research Site 224
• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL5 3JB
      • Active, not recruiting
      • Research Site 71
    • Torquay, Devon, United Kingdom, TQ2 7AA
      • Active, not recruiting
      • Research Site 153
  • Greater London
    • London, Greater London, United Kingdom, EC1M 6BQ
      • Active, not recruiting
      • Research Site 227
• United States
  • California
    • Bakersfield, California, United States, 93311
      • Active, not recruiting
      • Research Site 21
    • Beverly Hills, California, United States, 90211
      • Active, not recruiting
      • Research Site 9
    • Canoga Park, California, United States, 91303
      • Active, not recruiting
      • Research Site 11
    • Garden Grove, California, United States, 92844
      • Active, not recruiting
      • Research Site 40
    • Huntington Beach, California, United States, 92648
      • Active, not recruiting
      • Research Site 235
    • Lake Forest, California, United States, 92630
      • Active, not recruiting
      • Research Site 236
    • Lincoln, California, United States, 95648
      • Active, not recruiting
      • Research Site 39
    • Oxnard, California, United States, 93030
      • Active, not recruiting
      • Research Site 34
    • Palm Springs, California, United States, 92262
      • Active, not recruiting
      • Research Site 229
    • Redding, California, United States, 96001
      • Recruiting
      • Research Site 275
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Withdrawn
      • Research Site 155
    • Hialeah, Florida, United States, 33016
      • Active, not recruiting
      • Research Site 14
    • Miami, Florida, United States, 33144
      • Active, not recruiting
      • Research Site 154
    • Miami Lakes, Florida, United States, 33014
      • Active, not recruiting
      • Research Site 1
    • Mt. Dora, Florida, United States, 32757
      • Active, not recruiting
      • Research Site 42
    • North Miami, Florida, United States, 33162
      • Withdrawn
      • Research Site 38
    • Orlando, Florida, United States, 32825
      • Active, not recruiting
      • Research Site 41
    • Tamarac, Florida, United States, 33321
      • Active, not recruiting
      • Research Site 16
    • Tampa, Florida, United States, 33614
      • Active, not recruiting
      • Research Site 18
  • Georgia
    • Lawrenceville, Georgia, United States, 30044
      • Recruiting
      • Research Site 237
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Active, not recruiting
      • Research Site 17
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Active, not recruiting
      • Research Site 43
    • Indianapolis, Indiana, United States, 46290
      • Active, not recruiting
      • Research Site 157
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Active, not recruiting
      • Research Site 28
    • Topeka, Kansas, United States, 66606
      • Active, not recruiting
      • Research Site 23
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Active, not recruiting
      • Research Site 12
    • Baltimore, Maryland, United States, 21229
      • Active, not recruiting
      • Research Site 44
  • Michigan
    • Flint, Michigan, United States, 48532
      • Active, not recruiting
      • Research Site 30
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • Research Site 290
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Active, not recruiting
      • Research Site 33
    • Olive Branch, Mississippi, United States, 38654
      • Active, not recruiting
      • Research Site 32
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Active, not recruiting
      • Research Site 2
    • St Louis, Missouri, United States, 63136
      • Active, not recruiting
      • Research Site 232
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Active, not recruiting
      • Research Site 29
    • Omaha, Nebraska, United States, 68144
      • Active, not recruiting
      • Research Site 3
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Active, not recruiting
      • Research Site 77
  • New York
    • Long Island City, New York, United States, 11106
      • Recruiting
      • Research Site 72
    • New York, New York, United States, 10016
      • Active, not recruiting
      • Research Site 233
    • New York, New York, United States, 10029
      • Active, not recruiting
      • Research Site 228
    • Riverhead, New York, United States, 12401
      • Active, not recruiting
      • Research Site 273
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Active, not recruiting
      • Research Site 37
    • Morehead City, North Carolina, United States, 28557
      • Active, not recruiting
      • Research Site 36
    • Wilmington, North Carolina, United States, 28401
      • Recruiting
      • Research Site 169
  • Ohio
    • Beavercreek, Ohio, United States, 45431
      • Active, not recruiting
      • Research Site 22
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • Research Site 234
    • Vandalia, Ohio, United States, 45377
      • Recruiting
      • Research Site 294
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Active, not recruiting
      • Research Site 76
    • Oklahoma City, Oklahoma, United States, 73112
      • Active, not recruiting
      • Research Site 31
  • Pennsylvania
    • Horsham, Pennsylvania, United States, 19044
      • Active, not recruiting
      • Research Site 26
    • Newport, Pennsylvania, United States, 17074
      • Active, not recruiting
      • Research Site 8
    • Philadelphia, Pennsylvania, United States, 19104
      • Active, not recruiting
      • Research Site 231
  • South Carolina
    • Fort Mill, South Carolina, United States, 29707
      • Active, not recruiting
      • Research Site 238
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • Recruiting
      • Research Site 293
  • Texas
    • El Paso, Texas, United States, 79905
      • Active, not recruiting
      • Research Site 27
    • Fort Worth, Texas, United States, 76132
      • Active, not recruiting
      • Research Site 160
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • Research Site 272
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • Research Site 292
    • Houston, Texas, United States, 77061
      • Active, not recruiting
      • Research Site 73
    • Houston, Texas, United States, 77074
      • Active, not recruiting
      • Research Site 291
    • Houston, Texas, United States, 77090
      • Active, not recruiting
      • Research Site 75
    • Houston, Texas, United States, 77095
      • Active, not recruiting
      • Research Site 24
    • Missouri City, Texas, United States, 77459
      • Active, not recruiting
      • Research Site 230
    • Plano, Texas, United States, 75093
      • Active, not recruiting
      • Research Site 74
    • San Antonio, Texas, United States, 78230
      • Withdrawn
      • Research Site 168
    • Sugar Land, Texas, United States, 77479
      • Active, not recruiting
      • Research Site 13
    • Tomball, Texas, United States, 77375
      • Active, not recruiting
      • Research Site 170
    • Victoria, Texas, United States, 77901
      • Active, not recruiting
      • Research Site 25
  • Utah
    • Bountiful, Utah, United States, 84010
      • Active, not recruiting
      • Research Site 15
    • St. George, Utah, United States, 84790
      • Active, not recruiting
      • Research Site 35
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Active, not recruiting
      • Research Site 10
  • Washington
    • Seattle, Washington, United States, 98109
      • Active, not recruiting
      • Research Site 274

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed consent prior to the performance of any study-specific procedures
• Completed all required study visits per protocol in the parent study
• Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after the End of Study (EOS) or the last dose of plozasiran, whichever is later. Male subjects must agree to use a condom during the study and for at least 90 days after the EOS or last dose of plozasiran whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days after the EOS or last dose of plozasiran, whichever is later. Female subjects of childbearing potential on hormonal contraceptives must be stable on medication for >1 menstrual cycle prior to Day 1.
• Subjects 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)
• If the subject has a medical history of clinical atherosclerotic cardiovascular disease (ASCVD) or elevated 10-year ASCVD risk (eg, ≥7.5% per American Heart Association/American College of Cardiology [AHA/ACC] risk calculator for subjects ≥40 years of age or Framingham risk score calculator for subjects under the age of 40), the subject must be on appropriate lipid-lowering therapy as per local standard of care (ie, including moderate-to-high intensity statin, as indicated).

If the subject has diabetes:

1. Subject must be on optimized antidiabetic regimen as defined by the local standards, Investigator, and institutional practices
2. Subject must have no events of diabetic ketoacidosis, diabetic decompensation/ hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks of the Day 1 visit - Willing to follow diet counseling and maintain a stable low-fat diet

Subjects in the USA and Canada who completed protocol AROAPOC3-2003 meeting all eligibility criteria (with the exception of inclusion criteria #9 which is not applicable to these subjects) who also meet the following additional criteria may enroll in this trial:

• HbA1c ≤10% within 30 days prior to Day 1
• Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND either (c) or (d) below:
• Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001

• Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001

  • Subjects who previously met all eligibility requirements for AROAPOC3-3003, or AROAPOC3-3004 and were not permitted to proceed to randomization per Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. These subjects must meet all eligibility criteria prior to enrollment (with the exception of inclusion criteria #2 and #8 which are not applicable to these subjects) and have an HbA1c ≤10% within 30 days of Day 1.

Exclusion Criteria:

• Subject was permanently discontinued from receiving plozasiran in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or due to HbA1c elevation that did not respond to antidiabetic regimen
• Subject withdrew consent for continued study treatment in the parent study
• Known hypersensitivity to the active substance or to any of the excipients of plozasiran
• Known hypersensitivity to the active substance or to any of the excipients of plozasiran
• Any new condition or worsening of existing condition or any other situation that in the Investigator's judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at an additional safety risk
• Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.
• Poorly controlled glycemia (ie, HbA1c >10%) based upon the most recent HbA1c level reported in the parent trial prior to Day 1
• Acute pancreatitis within 4 weeks prior to Day 1
• Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides within 365 days before Day 1 (except plozasiran or inclisiran, which are permitted). Administration of inclisiran must be separated from administration of plozasiran by at least 4 weeks throughout the treatment period
• 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 PK, whichever is longer.
• Use of an investigational agent (other than plozasiran) or device within 30 days or within 5 half-lives, based on plasma PK, whichever is longer, prior to Day 1 (V1) or current participation in an interventional investigational study.
• Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days prior to Day 1. Individuals with stable well-controlled atrial arrhythmias will be allowed to participate in the study.
• Uncontrolled hypertension (ie, seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg) at Day 1; subject may be re-evaluated when hypertension is controlled.

Note: Other inclusion/exclusion criteria may apply per protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plozasiran Injection; 8 doses of plozasiran (ARO-APOC3) administered by subcutaneous (SC) injection	Drug: Plozasiran Injection; ARO-APOC3 injection; Other Names: ARO-APOC3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)	From first dose of study drug through Month 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline Over Time in Fasting Serum Triglyceride (TG) Levels	From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting Serum TG Levels	From first dose of study drug through Month 24
Change from Baseline Over Time in Apolipoprotein CIII (APOC3)	From first dose of study drug through Month 24
Percent Change from Baseline Over Time in APOC3	From first dose of study drug through Month 24
Change from Baseline Over Time in Remnant Cholesterol	From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Remnant Cholesterol	From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Non-High-Density Lipoprotein Cholesterol (non-HDL-C)	From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting non-HDL-C	From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting High-Density Lipoprotein Cholesterol (HDL-C)	From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting HDL-C	From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Total Apolipoprotein B (Apo B)	From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting Total Apo B	From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) using Ultracentrifugation	From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting LDL-C using Ultracentrifugation	From first dose of study drug through Month 24
Change from Baseline Over Time in Hemoglobin A1c (HbA1c)	From first dose of study drug through Month 24
Number of Participants With Emergent Apheresis	From first dose of study drug through Month 24
Adjudicated Major Adverse Cardiovascular Event Rates During the Treatment Period	From first dose of study drug through Month 24
Incidence of Anti-Drug Antibodies (ADA) to Plozasiran Over Time	From first dose of study drug through Month 24
Titers of ADA to Plozasiran Over Time	From first dose of study drug through Month 24
Adjudicated Acute Pancreatitis (AP) Event Rate During the Treatment Period	From first dose of study drug through Month 24

Collaborators and Investigators

• Sponsor: Arrowhead Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertriglyceridemia; plozasiran
• Other Study ID Numbers: AROAPOC3-3006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No