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
  • Ciudad Autonoma Buenos Aires, Argentina, 1425
    • Recruiting
    • Research Site 172
  • Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
    • Recruiting
    • Research Site 173
  • Córdoba, Argentina, X5000AAW
    • Recruiting
    • Research Site 171
  • Córdoba, Argentina, X5006CBI
    • Recruiting
    • Research Site 239
  • Córdoba, Argentina, X5008HHW
    • Recruiting
    • Research Site 240
  • Rosario, Argentina, 2000
    • Recruiting
    • Research Site 249
  • Buenos Aires
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1128AAF
      • Recruiting
      • Research Site 250
    • Ramos Mejía, Buenos Aires, Argentina, B1704ETD
      • Recruiting
      • Research Site 251
• Australia
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Recruiting
      • Research Site 86
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Research Site 253
    • Heidelberg Heights, Victoria, Australia, 3081
      • Recruiting
      • Research Site 252
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Research Site 174
• Belgium
  • Gozée, Belgium, 6534
    • Recruiting
    • Research Site 48
  • Gozée, Belgium, 6534
    • Recruiting
    • Research Site 91
  • Hasselt, Belgium, 3500
    • Recruiting
    • Research Site 87
  • Mechelen, Belgium, 2800
    • Recruiting
    • Research Site 47
  • Mechelen, Belgium, 97770
    • Recruiting
    • Research Site 90
  • Namur, Belgium, 5000
    • Recruiting
    • Research Site 46
  • Namur, Belgium, 5380
    • Recruiting
    • Research Site 89
  • Roeselare, Belgium, 8800
    • Recruiting
    • Research Site 175
  • Wetteren, Belgium, 9230
    • Recruiting
    • Research Site 45
  • Wetteren, Belgium, 9230
    • Recruiting
    • Research Site 88
• Brazil
  • São Paulo, Brazil, 04266-010
    • Recruiting
    • Research Site 177
  • São Paulo, Brazil, 05403-900
    • Recruiting
    • Research Site 179
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41810-010
      • Recruiting
      • Research Site 259
  • Federal District
    • Brasília, Federal District, Brazil, 70710-100
      • Recruiting
      • Research Site 257
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-274
      • Recruiting
      • Research Site 178
    • Belo Horizonte, Minas Gerais, Brazil, 30220-140
      • 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
      • Recruiting
      • Research Site 256
    • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
      • Recruiting
      • Research Site 258
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49055-530
      • Recruiting
      • Research Site 181
  • São Paulo
    • Campinas, São Paulo, Brazil, 13060-080
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      • Research Site 180
    • Votuporanga, São Paulo, Brazil, 15500-269
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      • Research Site 176
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Recruiting
    • Research Site 187
  • Dimitrovgrad, Bulgaria, 6400
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    • Research Site 100
  • Kardzhali, Bulgaria, 6600
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    • Research Site 54
  • Kardzhali, Bulgaria, 6600
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    • Research Site 98
  • Kyustendil, Bulgaria, 2500
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    • Research Site 52
  • Kyustendil, Bulgaria, 2500
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    • Research Site 96
  • Pleven, Bulgaria, 5800
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    • Research Site 49
  • Pleven, Bulgaria, 5800
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    • Research Site 92
  • Plovdiv, Bulgaria, 4002
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    • Research Site 50
  • Plovdiv, Bulgaria, 4002
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    • Research Site 93
  • Plovdiv, Bulgaria, 4001
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    • Research Site 185
  • Rousse, Bulgaria, 7013
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    • Research Site 94
  • Sofia, Bulgaria, 1404
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    • Research Site 53
  • Sofia, Bulgaria, 1616
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    • Research Site 51
  • Sofia, Bulgaria, 1616
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    • Research Site 95
  • Sofia, Bulgaria, 1618
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    • Research Site 97
  • Sofia, Bulgaria, 1431
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    • Research Site 182
  • Sofia, Bulgaria, 1431
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    • Research Site 183
  • Sofia, Bulgaria, 1431
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    • Research Site 186
  • Sofia, Bulgaria, 1527
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    • Research Site 184
  • Sofia, Bulgaria, 1582
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    • Research Site 260
  • Stara Zagora, Bulgaria, 6010
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    • Research Site 99
• Canada
  • Kitchener, Canada, N2H5Z8
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    • Research Site 56
  • Québec, Canada, G1G5X1
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    • Research Site 19
  • British Columbia
    • Victoria, British Columbia, Canada, V8T5G4
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      • Research Site 20
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, NS B3H 1V7
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      • Research Site 103
  • Ontario
    • London, Ontario, Canada, N6A 5K8
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      • Research Site 7
    • Sarnia, Ontario, Canada, N7T 4X3
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      • Research Site 101
    • Sarnia, Ontario, Canada, N7T 4X3
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      • Research Site 55
    • Toronto, Ontario, Canada, M5G 2C4
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      • Research Site 241
    • Waterloo, Ontario, Canada, N2T 0C1
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      • Research Site 102
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
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      • Research Site 6
    • Montreal, Quebec, Canada, H2W 1R7
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      • Research Site 5
    • Québec, Quebec, Canada, G1V 4W2
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      • Research Site 4
• China
  • Anhui
    • Bengbu, Anhui, China, 233004
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      • Research Site 191
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
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    • Beijing, Beijing Municipality, China, 100034
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    • Beijing, Beijing Municipality, China, 100091
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  • Guangdong
    • Guangzhou, Guangdong, China, 510000
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      • Research Site 62
    • Guangzhou, Guangdong, China, 510080
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      • Research Site 112
    • Guangzhou, Guangdong, China, 510180
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      • Research Site 111
  • Guangxi Zhuang
    • Liuzhou, Guangxi Zhuang, China, 545006
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      • Research Site 114
    • Liuzhou, Guangxi Zhuang, China, 545006
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      • Research Site 63
  • Hebei
    • Xingtai, Hebei, China, 054099
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      • Research Site 106
  • Henan
    • Luoyang, Henan, China, 471003
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      • Research Site 188
  • Hu'nan
    • Changsha, Hu'nan, China, 410011
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      • Research Site 107
    • Changsha, Hu'nan, China, 410011
      • Recruiting
      • Research Site 59
    • Changsha, Hu'nan, China, 410015
      • Recruiting
      • Research Site 108
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Research Site 261
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • Recruiting
      • Research Site 115
    • Baotou, Inner Mongolia, China, 14010
      • Recruiting
      • Research Site 64
  • Jiangsu
    • Suzhou, Jiangsu, China, 215002
      • Recruiting
      • Research Site 192
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • Research Site 110
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • Research Site 61
  • Shandong
    • Liaocheng, Shandong, China, 252000
      • Recruiting
      • Research Site 190
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200050
      • Recruiting
      • Research Site 189
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Research Site 243
  • Shanxi
    • Yuncheng, Shanxi, China, 44000
      • Recruiting
      • Research Site 105
    • Yuncheng, Shanxi, China, 44000
      • Recruiting
      • Research Site 58
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Recruiting
      • Research Site 113
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300121
      • Recruiting
      • Research Site 242
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • Research Site 109
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • Research Site 60
• Croatia
  • Karlovac, Croatia, 47000
    • Recruiting
    • Research Site 262
  • Zagreb, Croatia, 10000
    • Recruiting
    • Research Site 194
• Czechia
  • Hodonín, Czechia, 69501
    • Recruiting
    • Research Site 117
  • Hodonín, Czechia, 69501
    • Recruiting
    • Research Site 65
  • Hradec Králové, Czechia, 50005
    • Recruiting
    • Research Site 197
  • Náchod, Czechia, 547 01
    • Recruiting
    • Research Site 264
  • Olomouc, Czechia, CZ77900
    • Recruiting
    • Research Site 118
  • Prague, Czechia, 11000
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    • Research Site 119
  • Prague, Czechia, 11000
    • Recruiting
    • Research Site 66
  • Prague, Czechia, 140 21
    • Recruiting
    • Research Site 244
  • Praha 4-Krc, Czechia, 140 59
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    • Research Site 116
  • Slaný, Czechia, 27401
    • Recruiting
    • Research Site 263
  • Teplice, Czechia, 41501
    • Recruiting
    • Research Site 198
  • Trutnov, Czechia, 541 01
    • Recruiting
    • Research Site 196
  • Ústí nad Labem, Czechia, 40113
    • Recruiting
    • Research Site 195
• France
  • Bouches-du-Rhône
    • Marseille, Bouches-du-Rhône, France, 13005
      • Recruiting
      • Research Site 199
  • Gironde
    • Pessac, Gironde, France, 33604
      • Recruiting
      • Research Site 120
  • Paris
    • Paris, Paris, France, 75013
      • Recruiting
      • Research Site 200
• Germany
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39120
      • Recruiting
      • Research Site 201
• Hungary
  • Budapest, Hungary, 1051
    • Recruiting
    • Research Site 123
  • Budapest, Hungary, 1132
    • Recruiting
    • Research Site 122
  • Budapest, Hungary, 1132
    • Recruiting
    • Research Site 68
  • Budapest, Hungary, 1033
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    • Research Site 204
  • Budapest, Hungary, 1152
    • Recruiting
    • Research Site 265
  • Miskolc, Hungary, 3530
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    • Research Site 205
  • Pécs, Hungary, 7623
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    • Research Site 121
  • Pécs, Hungary, 7623
    • Recruiting
    • Research Site 67
  • Veszprém, Hungary, 8200
    • Recruiting
    • Research Site 202
  • Zalaegerszeg, Hungary, 8900
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    • Research Site 203
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Research Site 245
  • Brescia, Italy, 25123
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    • Research Site 208
  • Milan, Italy, 20162
    • Recruiting
    • Research Site 207
  • Palermo, Italy, 90127
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    • Research Site 210
  • Roma, Italy, 00168
    • Recruiting
    • Research Site 206
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Research Site 209
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Recruiting
    • Research Site 124
  • Daugavpils, Latvia, LV-5410
    • Recruiting
    • Research Site 212
  • Riga, Latvia, LV1063
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    • Research Site 125
  • Riga, Latvia, LV1063
    • Recruiting
    • Research Site 69
  • Riga, Latvia, LV-1002
    • Recruiting
    • Research Site 211
• Lithuania
  • Kaunas, Lithuania, 49387
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    • Research Site 126
  • Kaunas, Lithuania, 49387
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    • Research Site 70
  • Kaunas, Lithuania, LT-50177
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    • Research Site 213
  • Kaunas, Lithuania, 49449
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    • Research Site 246
  • Vilnius, Lithuania, LT-08661
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    • Research Site 214
  • Vilnius, Lithuania, LT-08661
    • Recruiting
    • Research Site 266
  • Šiauliai, Lithuania, LT-76206
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    • Research Site 127
• New Zealand
  • Christchurch, New Zealand, 08011
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    • Research Site 128
  • Wellington, New Zealand, 6021
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    • Research Site 129
• Poland
  • Elblag, Poland, 82-300
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    • Research Site 130
  • Elblag, Poland, 82-300
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    • Research Site 78
  • Gdynia, Poland, 81-338
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    • Research Site 247
  • Katowice, Poland, 40-156
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    • Research Site 134
  • Katowice, Poland, 40-156
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    • Research Site 81
  • Katowice, Poland, 40-752
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    • Research Site 141
  • Katowice, Poland, 40-752
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    • Research Site 85
  • Krakow, Poland, 31-501
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    • Research Site 138
  • Krakow, Poland, 31-501
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    • Research Site 83
  • Lodz, Poland, 91-363
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    • Research Site 136
  • Lodz, Poland, 94-255
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    • Research Site 131
  • Lodz, Poland, 94-255
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    • Research Site 79
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  • Szczecin, Poland, 71- 500
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    • Research Site 135
  • Warsaw, Poland, 00-215
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  • Warsaw, Poland, 00-215
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  • Wroclaw, Poland, 51-314
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    • Research Site 133
  • Wroclaw, Poland, 53-673
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    • Research Site 140
  • Wroclaw, Poland, 53-030
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  • Zamość, Poland, 22-400
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  • Żarów, Poland, 58-130
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    • Research Site 137
  • Żarów, Poland, 58-130
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• Romania
  • Bucharest, Romania, 010192
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    • Research Site 142
  • Galati, Romania, 800291
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    • Research Site 217
  • Ploieşti, Romania, 100342
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    • Research Site 143
  • Timișoara, Romania, 300362
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    • Research Site 145
  • Târgu Mureş, Romania, 540136
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    • Research Site 144
• Slovakia
  • Banská Bystrica, Slovakia, 97401
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    • Research Site 268
  • Bardejov, Slovakia, 08501
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  • Košice, Slovakia, 04001
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  • Moldava nad Bodvou, Slovakia, 045 01
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    • Research Site 218
  • Nitra, Slovakia, 950 01
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    • Research Site 248
  • Rožňava, Slovakia, 048 01
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    • Research Site 148
• South Africa
  • Gauteng
    • Krugersdorp, Gauteng, South Africa, 1739
      • Recruiting
      • Research Site 219
    • Pretoria, Gauteng, South Africa, 0181
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      • Research Site 270
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
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      • Research Site 222
    • Cape Town, Western Cape, South Africa, 7570
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    • Cape Town, Western Cape, South Africa, 7925
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    • Mossel Bay, Western Cape, South Africa, 6500
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      • Research Site 269
    • Somerset West, Western Cape, South Africa, 7130
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• Spain
  • Barcelona, Spain, 08035
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  • Barcelona, Spain, 08023
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  • Madrid, Spain, 28041
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  • Seville, Spain, 41013
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  • Valencia, Spain, 46010
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  • Zaragoza, Spain, 50009
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  • La Coruña
    • A Coruña, La Coruña, Spain, 15006
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• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL5 3JB
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      • Research Site 152
    • Plymouth, Devon, United Kingdom, PL5 3JB
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      • Research Site 71
    • Torquay, Devon, United Kingdom, TQ2 7AA
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  • Greater London
    • London, Greater London, United Kingdom, EC1M 6BQ
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      • Research Site 227
• United States
  • California
    • Bakersfield, California, United States, 93311
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    • Beverly Hills, California, United States, 90211
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    • Huntington Beach, California, United States, 92648
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  • Florida
    • Fort Lauderdale, Florida, United States, 33308
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    • Miami, Florida, United States, 33144
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    • Elkhart, Indiana, United States, 46514-2487
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    • Overland Park, Kansas, United States, 66211
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    • Annapolis, Maryland, United States, 21401
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  • Michigan
    • Flint, Michigan, United States, 48532
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  • Missouri
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    • St Louis, Missouri, United States, 63136
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    • Summit, New Jersey, United States, 07901
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    • Long Island City, New York, United States, 11106
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  • North Carolina
    • Asheboro, North Carolina, United States, 27203
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  • Ohio
    • Beavercreek, Ohio, United States, 45431
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  • Oklahoma
    • Norman, Oklahoma, United States, 73072
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    • Norman, Oklahoma, United States, 73072
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    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • Research Site 31
  • Pennsylvania
    • Horsham, Pennsylvania, United States, 19044
      • Recruiting
      • Research Site 26
    • Newport, Pennsylvania, United States, 17074
      • Recruiting
      • Research Site 8
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Research Site 231
  • South Carolina
    • Fort Mill, South Carolina, United States, 29707
      • Recruiting
      • Research Site 238
  • Texas
    • El Paso, Texas, United States, 19044
      • Recruiting
      • Research Site 27
    • Fort Worth, Texas, United States, 76132
      • Recruiting
      • Research Site 160
    • Houston, Texas, United States, 77095
      • Recruiting
      • Research Site 24
    • Houston, Texas, United States, 77061
      • Recruiting
      • Research Site 158
    • Houston, Texas, United States, 77061
      • Recruiting
      • Research Site 73
    • Houston, Texas, United States, 77090
      • Recruiting
      • Research Site 163
    • Houston, Texas, United States, 77090
      • Recruiting
      • Research Site 75
    • Houston, Texas, United States, 77030
      • Recruiting
      • Research Site 272
    • Missouri City, Texas, United States, 77459
      • Recruiting
      • Research Site 230
    • Plano, Texas, United States, 75093
      • Recruiting
      • Research Site 161
    • Plano, Texas, United States, 75093
      • Recruiting
      • Research Site 74
    • San Antonio, Texas, United States, 78230
      • Recruiting
      • Research Site 168
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Research Site 13
    • Tomball, Texas, United States, 77375
      • Recruiting
      • Research Site 170
    • Victoria, Texas, United States, 77901
      • Recruiting
      • Research Site 25
  • Utah
    • Bountiful, Utah, United States, 84010
      • Recruiting
      • Research Site 15
    • St. George, Utah, United States, 84790
      • Recruiting
      • Research Site 35
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Recruiting
      • Research Site 10
  • Washington
    • Seattle, Washington, United States, 98109
      • 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): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 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