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Langsigtet sikkerhed og effektivitet af Plozasiran hos voksne med hypertriglyceridæmi (SHASTA-10)

29. september 2026 opdateret af: Arrowhead Pharmaceuticals

En fase 3 åben-label-udvidelsesundersøgelse for at evaluere den langsigtede sikkerhed og effektivitet af Plozasiran hos voksne med hypertriglyceridæmi (Shasta-10-undersøgelse)

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

710

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1056ABI
        • Research Site 277
      • Ciudad Autonoma Buenos Aires, Argentina, 1425
        • Research Site 172
      • Ciudad Autonoma Buenos Aires, Argentina, C1417
        • Research Site 276
      • Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
        • Research Site 173
      • Córdoba, Argentina, 5000
        • Research Site 278
      • Córdoba, Argentina, X5000AAW
        • Research Site 171
      • Córdoba, Argentina, X5006CBI
        • Research Site 239
      • Córdoba, Argentina, X5008HHW
        • Research Site 240
      • Rosario, Argentina, 2000
        • Research Site 249
    • Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1128AAF
        • Research Site 250
      • Ramos Mejía, Buenos Aires, Argentina, B1704ETD
        • Research Site 251
  • Australien
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Research Site 86
      • Clayton, Victoria, Australien, 3168
        • Research Site 253
      • Heidelberg Heights, Victoria, Australien, 3081
        • Research Site 252
    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
        • Research Site 174
  • Belgien
      • Gozée, Belgien, 6534
        • Research Site 48
      • Hasselt, Belgien, 3500
        • Research Site 87
      • Mechelen, Belgien, 97770
        • Research Site 90
      • Namur, Belgien, 5000
        • Research Site 46
      • Namur, Belgien, 5380
        • Research Site 89
      • Roeselare, Belgien, 8800
        • Research Site 175
      • Wetteren, Belgien, 9230
        • Research Site 45
  • Brasilien
      • Campina Grande do Sul, Brasilien, 83430-000
        • Research Site 279
      • Paranã, Brasilien, 80730-150
        • Research Site 296
      • Salvador, Brasilien, 40170310
        • Research Site 281
      • Salvador, Brasilien, 40323-010
        • Research Site 280
      • São Paulo, Brasilien, 04266-010
        • Research Site 177
      • São Paulo, Brasilien, 05403-900
        • Research Site 179
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasilien, 41810-010
        • Research Site 259
    • Federal District
      • Brasília, Federal District, Brasilien, 70710-100
        • Research Site 257
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilien, 30150-274
        • Research Site 178
      • Belo Horizonte, Minas Gerais, Brasilien, 30220-140
        • Research Site 255
    • Pará
      • Belém, Pará, Brasilien, 66073-000
        • Research Site 254
    • Rio Grande do Sul
      • Canoas, Rio Grande do Sul, Brasilien, 92425-900
        • Research Site 256
    • Sergipe
      • Aracaju, Sergipe, Brasilien, 49055-530
        • Research Site 181
    • São Paulo
      • Campinas, São Paulo, Brasilien, 13060-080
        • Research Site 180
      • Votuporanga, São Paulo, Brasilien, 15500-269
        • Research Site 176
  • Bulgarien
      • Burgas, Bulgarien, 8000
        • Research Site 187
      • Dimitrovgrad, Bulgarien, 6400
        • Research Site 100
      • Kardzhali, Bulgarien, 6600
        • Research Site 98
      • Kyustendil, Bulgarien, 2500
        • Research Site 52
      • Pleven, Bulgarien, 5800
        • Research Site 49
      • Plovdiv, Bulgarien, 4001
        • Research Site 185
      • Plovdiv, Bulgarien, 4002
        • Research Site 50
      • Rousse, Bulgarien, 7013
        • Research Site 94
      • Sofia, Bulgarien, 1404
        • Research Site 53
      • Sofia, Bulgarien, 1431
        • Research Site 182
      • Sofia, Bulgarien, 1431
        • Research Site 186
      • Sofia, Bulgarien, 1510
        • Research Site 282
      • Sofia, Bulgarien, 1527
        • Research Site 184
      • Sofia, Bulgarien, 1582
        • Research Site 260
      • Sofia, Bulgarien, 1616
        • Research Site 51
      • Sofia, Bulgarien, 1618
        • Research Site 97
      • Sofia, Bulgarien, 1756
        • Research Site 283
      • Stara Zagora, Bulgarien, 6010
        • Research Site 99
  • Canada
      • Kitchener, Canada, N2H5Z8
        • Research Site 56
      • Québec, Canada, G1G5X1
        • Research Site 19
    • British Columbia
      • Victoria, British Columbia, Canada, V8T5G4
        • Research Site 20
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, NS B3H 1V7
        • Research Site 103
    • Ontario
      • London, Ontario, Canada, N6A 5K8
        • Research Site 7
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site 55
      • Toronto, Ontario, Canada, M5G 2C4
        • Research Site 241
      • Waterloo, Ontario, Canada, N2T 0C1
        • Research Site 102
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Research Site 6
      • Montreal, Quebec, Canada, H2W 1R7
        • Research Site 5
      • Québec, Quebec, Canada, G1V 4W2
        • Research Site 4
  • Det Forenede Kongerige
    • Devon
      • Plymouth, Devon, Det Forenede Kongerige, PL5 3JB
        • Research Site 71
      • Torquay, Devon, Det Forenede Kongerige, TQ2 7AA
        • Research Site 153
    • Greater London
      • London, Greater London, Det Forenede Kongerige, EC1M 6BQ
        • Research Site 227
  • Forenede Stater
    • California
      • Bakersfield, California, Forenede Stater, 93311
        • Research Site 21
      • Beverly Hills, California, Forenede Stater, 90211
        • Research Site 9
      • Canoga Park, California, Forenede Stater, 91303
        • Research Site 11
      • Garden Grove, California, Forenede Stater, 92844
        • Research Site 40
      • Huntington Beach, California, Forenede Stater, 92648
        • Research Site 235
      • Lake Forest, California, Forenede Stater, 92630
        • Research Site 236
      • Lincoln, California, Forenede Stater, 95648
        • Research Site 39
      • Oxnard, California, Forenede Stater, 93030
        • Research Site 34
      • Palm Springs, California, Forenede Stater, 92262
        • Research Site 229
      • Redding, California, Forenede Stater, 96001
        • Research Site 275
    • Florida
      • Hialeah, Florida, Forenede Stater, 33016
        • Research Site 14
      • Miami, Florida, Forenede Stater, 33144
        • Research Site 154
      • Miami Lakes, Florida, Forenede Stater, 33014
        • Research Site 1
      • Mt. Dora, Florida, Forenede Stater, 32757
        • Research Site 42
      • Orlando, Florida, Forenede Stater, 32825
        • Research Site 41
      • Tamarac, Florida, Forenede Stater, 33321
        • Research Site 16
      • Tampa, Florida, Forenede Stater, 33614
        • Research Site 18
    • Georgia
      • Lawrenceville, Georgia, Forenede Stater, 30044
        • Research Site 237
    • Illinois
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Research Site 17
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46514
        • Research Site 43
      • Indianapolis, Indiana, Forenede Stater, 46290
        • Research Site 157
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66211
        • Research Site 28
      • Topeka, Kansas, Forenede Stater, 66606
        • Research Site 23
    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • Research Site 12
      • Baltimore, Maryland, Forenede Stater, 21229
        • Research Site 44
    • Michigan
      • Flint, Michigan, Forenede Stater, 48532
        • Research Site 30
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Research Site 290
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
        • Research Site 33
      • Olive Branch, Mississippi, Forenede Stater, 38654
        • Research Site 32
    • Missouri
      • Jefferson City, Missouri, Forenede Stater, 65109
        • Research Site 2
      • St Louis, Missouri, Forenede Stater, 63136
        • Research Site 232
    • Nebraska
      • Fremont, Nebraska, Forenede Stater, 68025
        • Research Site 29
      • Omaha, Nebraska, Forenede Stater, 68144
        • Research Site 3
    • New Jersey
      • Summit, New Jersey, Forenede Stater, 07901
        • Research Site 77
    • New York
      • Long Island City, New York, Forenede Stater, 11106
        • Research Site 72
      • New York, New York, Forenede Stater, 10016
        • Research Site 233
      • New York, New York, Forenede Stater, 10029
        • Research Site 228
      • Riverhead, New York, Forenede Stater, 12401
        • Research Site 273
    • North Carolina
      • Asheboro, North Carolina, Forenede Stater, 27203
        • Research Site 37
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Research Site 36
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Research Site 169
    • Ohio
      • Beavercreek, Ohio, Forenede Stater, 45431
        • Research Site 22
      • Columbus, Ohio, Forenede Stater, 43214
        • Research Site 234
      • Vandalia, Ohio, Forenede Stater, 45377
        • Research Site 294
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73072
        • Research Site 76
      • Oklahoma City, Oklahoma, Forenede Stater, 73135
        • Research Site
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Research Site 31
    • Pennsylvania
      • Horsham, Pennsylvania, Forenede Stater, 19044
        • Research Site 26
      • Newport, Pennsylvania, Forenede Stater, 17074
        • Research Site 8
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Research Site 231
    • South Carolina
      • Fort Mill, South Carolina, Forenede Stater, 29707
        • Research Site 238
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37411
        • Research Site 293
    • Texas
      • El Paso, Texas, Forenede Stater, 79905
        • Research Site 27
      • Fort Worth, Texas, Forenede Stater, 76132
        • Research Site 160
      • Houston, Texas, Forenede Stater, 77030
        • Research Site 272
      • Houston, Texas, Forenede Stater, 77030
        • Research Site 292
      • Houston, Texas, Forenede Stater, 77061
        • Research Site 73
      • Houston, Texas, Forenede Stater, 77074
        • Research Site 291
      • Houston, Texas, Forenede Stater, 77090
        • Research Site 75
      • Houston, Texas, Forenede Stater, 77095
        • Research Site 24
      • Missouri City, Texas, Forenede Stater, 77459
        • Research Site 230
      • Plano, Texas, Forenede Stater, 75093
        • Research Site 74
      • Sugar Land, Texas, Forenede Stater, 77479
        • Research Site 13
      • Tomball, Texas, Forenede Stater, 77375
        • Research Site 170
      • Victoria, Texas, Forenede Stater, 77901
        • Research Site 25
    • Utah
      • Bountiful, Utah, Forenede Stater, 84010
        • Research Site 15
      • St. George, Utah, Forenede Stater, 84790
        • Research Site 35
    • Virginia
      • Manassas, Virginia, Forenede Stater, 20110
        • Research Site 10
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Research Site 274
  • Frankrig
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, Frankrig, 13005
        • Research Site 199
    • Gironde
      • Pessac, Gironde, Frankrig, 33604
        • Research Site 120
    • Paris
      • Paris, Paris, Frankrig, 75013
        • Research Site 200
  • Italien
      • Bologna, Italien, 40138
        • Research Site 245
      • Brescia, Italien, 25123
        • Research Site 208
      • Milan, Italien, 20162
        • Research Site 207
      • Palermo, Italien, 90127
        • Research Site 210
      • Roma, Italien, 00168
        • Research Site 206
    • Milano
      • Rozzano, Milano, Italien, 20089
        • Research Site 209
  • Japan
      • Chiba, Japan, 260-8677
        • Research Site
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 329-0498
        • Research Site
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-0033
        • Research Site
  • Kina
      • Beijing, Kina, 100730
        • Research Site 295
    • Anhui
      • Bengbu, Anhui, Kina, 233004
        • Research Site 191
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100034
        • Research Site 104
      • Beijing, Beijing Municipality, Kina, 100091
        • Research Site 193
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
        • Research Site 62
      • Guangzhou, Guangdong, Kina, 510180
        • Research Site 111
    • Guangxi Zhuang
      • Liuzhou, Guangxi Zhuang, Kina, 545006
        • Research Site 63
    • Hebei
      • Xingtai, Hebei, Kina, 054099
        • Research Site 106
    • Henan
      • Luoyang, Henan, Kina, 471003
        • Research Site 188
    • Hu'nan
      • Changsha, Hu'nan, Kina, 410011
        • Research Site 59
      • Changsha, Hu'nan, Kina, 410015
        • Research Site 108
    • Hubei
      • Wuhan, Hubei, Kina, 430060
        • Research Site 261
    • Inner Mongolia
      • Baotou, Inner Mongolia, Kina, 014010
        • Research Site 115
    • Jiangsu
      • Suzhou, Jiangsu, Kina, 215002
        • Research Site 192
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • Research Site 61
    • Shandong
      • Liaocheng, Shandong, Kina, 252000
        • Research Site 190
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200040
        • Research Site 243
      • Shanghai, Shanghai Municipality, Kina, 200050
        • Research Site 189
    • Shanxi
      • Yuncheng, Shanxi, Kina, 44000
        • Research Site 105
    • Sichuan
      • Chengdu, Sichuan, Kina, 610072
        • Research Site 113
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300121
        • Research Site 242
    • Zhejiang
      • Wenzhou, Zhejiang, Kina, 325000
        • Research Site 60
  • Kroatien
      • Karlovac, Kroatien, 47000
        • Research Site 262
      • Zagreb, Kroatien, 10000
        • Research Site 194
  • Letland
      • Daugavpils, Letland, LV-5410
        • Research Site 212
      • Daugavpils, Letland, LV-5417
        • Research Site 124
      • Riga, Letland, LV-1002
        • Research Site 211
      • Riga, Letland, LV-1038
        • Research Site 287
      • Riga, Letland, LV1063
        • Research Site 69
  • Litauen
      • Kaunas, Litauen, 49387
        • Research Site 70
      • Kaunas, Litauen, 49449
        • Research Site 246
      • Kaunas, Litauen, LT-50177
        • Research Site 213
      • Vilnius, Litauen, LT-08661
        • Research Site 214
      • Šiauliai, Litauen, LT-76206
        • Research Site 127
  • New Zealand
      • Christchurch, New Zealand, 08011
        • Research Site 128
      • Wellington, New Zealand, 6021
        • Research Site 129
  • Polen
      • Elblag, Polen, 82-300
        • Research Site 78
      • Gdynia, Polen, 81-338
        • Research Site 247
      • Katowice, Polen, 40-156
        • Research Site 81
      • Katowice, Polen, 40-752
        • Research Site 141
      • Katowice, Polen, 40-752
        • Research Site 85
      • Krakow, Polen, 31-501
        • Research Site 83
      • Lodz, Polen, 91-363
        • Research Site 136
      • Lodz, Polen, 94-255
        • Research Site 131
      • Lodz, Polen, 94-255
        • Research Site 79
      • Malbork, Polen, 82-200
        • Research Site 80
      • Szczecin, Polen, 71- 500
        • Research Site 135
      • Warsaw, Polen, 00-215
        • Research Site 84
      • Warsaw, Polen, 03-291
        • Research Site 216
      • Wroclaw, Polen, 53-030
        • Research Site 267
      • Zamość, Polen, 22-400
        • Research Site 215
      • Żarów, Polen, 58-130
        • Research Site 82
  • Rumænien
      • Bucharest, Rumænien, 010192
        • Research Site 142
      • Galati, Rumænien, 800291
        • Research Site 217
      • Ploieşti, Rumænien, 100342
        • Research Site 143
      • Timișoara, Rumænien, 300362
        • Research Site 145
      • Târgu Mureş, Rumænien, 540136
        • Research Site 144
  • Slovakiet
      • Banská Bystrica, Slovakiet, 97401
        • Research Site 268
      • Bardejov, Slovakiet, 08501
        • Research Site 147
      • Košice, Slovakiet, 04001
        • Research Site 146
      • Moldava nad Bodvou, Slovakiet, 045 01
        • Research Site 218
      • Nitra, Slovakiet, 950 01
        • Research Site 248
      • Rožňava, Slovakiet, 048 01
        • Research Site 148
  • Spanien
      • Barcelona, Spanien, 08023
        • Research Site 271
      • Barcelona, Spanien, 08035
        • Research Site 223
      • Madrid, Spanien, 28041
        • Research Site 226
      • Santiago de Compostela, Spanien, 15706
        • Research Site 289
      • Seville, Spanien, 41013
        • Research Site 150
      • Valencia, Spanien, 46010
        • Research Site 225
      • Zaragoza, Spanien, 50009
        • Research Site 151
    • La Coruña
      • A Coruña, La Coruña, Spanien, 15006
        • Research Site 224
  • Sydafrika
      • Cape Town, Sydafrika, 7530
        • Research Site 288
    • Gauteng
      • Krugersdorp, Gauteng, Sydafrika, 1739
        • Research Site 219
      • Pretoria, Gauteng, Sydafrika, 0181
        • Research Site 270
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7500
        • Research Site 222
      • Cape Town, Western Cape, Sydafrika, 7570
        • Research Site 220
      • Cape Town, Western Cape, Sydafrika, 7925
        • Research Site 221
      • Mossel Bay, Western Cape, Sydafrika, 6500
        • Research Site 269
      • Somerset West, Western Cape, Sydafrika, 7130
        • Research Site 149
  • Tjekkiet
      • Hodonín, Tjekkiet, 69501
        • Research Site 65
      • Hradec Králové, Tjekkiet, 50005
        • Research Site 197
      • Náchod, Tjekkiet, 547 01
        • Research Site 264
      • Olomouc, Tjekkiet, CZ77900
        • Research Site 118
      • Prague, Tjekkiet, 11000
        • Research Site 119
      • Prague, Tjekkiet, 11000
        • Research Site 66
      • Prague, Tjekkiet, 140 21
        • Research Site 244
      • Praha 4-Krc, Tjekkiet, 140 59
        • Research Site 116
      • Slaný, Tjekkiet, 27401
        • Research Site 263
      • Teplice, Tjekkiet, 41501
        • Research Site 198
      • Trutnov, Tjekkiet, 541 01
        • Research Site 196
      • Ústí nad Labem, Tjekkiet, 40113
        • Research Site 195
  • Tyskland
      • Berlin, Tyskland, 13353
        • Research Site 285
      • Deggingen, Tyskland, 73326
        • Research Site 284
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Tyskland, 39120
        • Research Site 201
  • Ungarn
      • Budapest, Ungarn, 1033
        • Research Site 204
      • Budapest, Ungarn, 1051
        • Research Site 123
      • Budapest, Ungarn, 1132
        • Research Site 68
      • Budapest, Ungarn, 1152
        • Research Site 265
      • Miskolc, Ungarn, 3530
        • Research Site 205
      • Pécs, Ungarn, 7623
        • Research Site 67
      • Szeged, Ungarn, 6725
        • Research Site 286
      • Veszprém, Ungarn, 8200
        • Research Site 202
      • Zalaegerszeg, Ungarn, 8900
        • Research Site 203

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Plozasiran Injection

8 doses of plozasiran (ARO-APOC3) administered by subcutaneous (SC) injection
Medicin: Plozasiran Injection

ARO-APOC3 injection

Andre navne:
  • ARO-APOC3

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Antal deltagere med behandling af bivirkninger
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24

Sekundære resultatmål

Resultatmål
Tidsramme
Skift fra baseline over tid i fastende serum triglycerid (TG) niveauer
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Procentændring fra baseline over tid i faste serum TG -niveauer
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Skift fra baseline over tid i apolipoprotein CIII (APOC3)
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Procentændring fra baseline over tid i APOC3
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Skift fra baseline over tid i restkolesterol
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Procentændring fra baseline over tid i restkolesterol
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Ændring fra baseline over tid i fastende lipoprotein-kolesterol med ikke-høj densitet (ikke-HDL-C)
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Procentændring fra baseline over tid i fastende ikke-HDL-C
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Ændring fra baseline over tid i fastende lipoproteinkolesterol med høj densitet (HDL-C)
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Procentændring fra baseline over tid i faste HDL-C
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Skift fra baseline over tid i faste total apolipoprotein B (APO B)
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Procentændring fra baseline over tid i fastende total apo B
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Skift fra baseline over tid i fastende lipoprotein-kolesterol med lav densitet (LDL-C) ved hjælp af ultracentrifugering
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Procentændring fra baseline over tid i fastende LDL-C ved hjælp af ultracentrifugering
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Skift fra baseline over tid i hæmoglobin A1C (HBA1C)
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Antal deltagere med opstående aferesis
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Bedømmede store bivirkninger på kardiovaskulære hændelser i behandlingsperioden
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Forekomst af anti-narkotikarantistoffer (ADA) til Plozasiran over tid
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Titere af ADA til Plozasiran over tid
Tidsramme: Fra første dosis af studiemedicin gennem måned 24
Fra første dosis af studiemedicin gennem måned 24
Rate for afgjort akut pankreatitis (AP) hændelse under behandlingsperioden
Tidsramme: Fra første dosis af undersøgelsesmedicin til og med måned 24
Fra første dosis af undersøgelsesmedicin til og med måned 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Arrowhead Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. april 2025

Primær færdiggørelse (Anslået)

1. juli 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

7. februar 2025

Først indsendt, der opfyldte QC-kriterier

7. februar 2025

Først opslået (Faktiske)

12. februar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AROAPOC3-3006

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner