HypertriglyceridemiaPhase 3SHASTA-10NCT06822790
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
A Phase 3 study testing Plozasiran Injection in people with Hypertriglyceridemia, run by Arrowhead Pharmaceuticals at 253 sites in 24 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Plozasiran Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 253 sitesin 24 countries
- Study dates
- 9 Apr 2025to Jul 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Subject must be on optimized antidiabetic regimen as defined by the local standards, Investigator, and institutional practices
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
253 sites in 24 countries.
253 sites in 24 countries
United States69 sites
Research Site 12
Annapolis, Maryland, 21401
Research Site 37
Asheboro, North Carolina, 27203
Research Site 21
Bakersfield, California, 93311
Research Site 44
Baltimore, Maryland, 21229
Research Site 22
Beavercreek, Ohio, 45431
Research Site 9
Beverly Hills, California, 90211
Research Site 15
Bountiful, Utah, 84010
Research Site 11
Canoga Park, California, 91303
Research Site 293
Chattanooga, Tennessee, 37411
Research Site 234
Columbus, Ohio, 43214
Research Site 27
El Paso, Texas, 79905
Research Site 43
Elkhart, Indiana, 46514
Research Site 30
Flint, Michigan, 48532
Research Site 238
Fort Mill, South Carolina, 29707
Research Site 160
Fort Worth, Texas, 76132
Research Site 29
Fremont, Nebraska, 68025
Research Site 40
Garden Grove, California, 92844
Research Site 14
Hialeah, Florida, 33016
Research Site 26
Horsham, Pennsylvania, 19044
Research Site 272
Houston, Texas, 77030
Research Site 292
Houston, Texas, 77030
Research Site 73
Houston, Texas, 77061
Research Site 291
Houston, Texas, 77074
Research Site 75
Houston, Texas, 77090
Research Site 24
Houston, Texas, 77095
Research Site 235
Huntington Beach, California, 92648
Research Site 157
Indianapolis, Indiana, 46290
Research Site 33
Jackson, Mississippi, 39202
Research Site 2
Jefferson City, Missouri, 65109
Research Site 236
Lake Forest, California, 92630
Research Site 237
Lawrenceville, Georgia, 30044
Research Site 39
Lincoln, California, 95648
Research Site 72
Long Island City, New York, 11106
Research Site 10
Manassas, Virginia, 20110
Research Site 154
Miami, Florida, 33144
Research Site 1
Miami Lakes, Florida, 33014
Research Site 290
Minneapolis, Minnesota, 55455
Research Site 230
Missouri City, Texas, 77459
Research Site 36
Morehead City, North Carolina, 28557
Research Site 42
Mt. Dora, Florida, 32757
Research Site 233
New York, New York, 10016
Research Site 228
New York, New York, 10029
Research Site 8
Newport, Pennsylvania, 17074
Research Site 76
Norman, Oklahoma, 73072
Research Site 31
Oklahoma City, Oklahoma, 73112
Research Site
Oklahoma City, Oklahoma, 73135
Research Site 32
Olive Branch, Mississippi, 38654
Research Site 3
Omaha, Nebraska, 68144
Research Site 41
Orlando, Florida, 32825
Research Site 28
Overland Park, Kansas, 66211
Research Site 34
Oxnard, California, 93030
Research Site 229
Palm Springs, California, 92262
Research Site 17
Park Ridge, Illinois, 60068
Research Site 231
Philadelphia, Pennsylvania, 19104
Research Site 74
Plano, Texas, 75093
Research Site 275
Redding, California, 96001
Research Site 273
Riverhead, New York, 12401
Research Site 274
Seattle, Washington, 98109
Research Site 232
St Louis, Missouri, 63136
Research Site 35
St. George, Utah, 84790
Research Site 13
Sugar Land, Texas, 77479
Research Site 77
Summit, New Jersey, 07901
Research Site 16
Tamarac, Florida, 33321
Research Site 18
Tampa, Florida, 33614
Research Site 170
Tomball, Texas, 77375
Research Site 23
Topeka, Kansas, 66606
Research Site 294
Vandalia, Ohio, 45377
Research Site 25
Victoria, Texas, 77901
Research Site 169
Wilmington, North Carolina, 28401
China22 sites
Research Site 115
Baotou, Inner Mongolia, 014010
Research Site 104
Beijing, Beijing Municipality, 100034
Research Site 193
Beijing, Beijing Municipality, 100091
Research Site 295
Beijing, 100730
Research Site 191
Bengbu, Anhui, 233004
Research Site 59
Changsha, Hu'nan, 410011
Research Site 108
Changsha, Hu'nan, 410015
Research Site 113
Chengdu, Sichuan, 610072
Research Site 62
Guangzhou, Guangdong, 510000
Research Site 111
Guangzhou, Guangdong, 510180
Research Site 190
Liaocheng, Shandong, 252000
Research Site 63
Liuzhou, Guangxi Zhuang, 545006
Research Site 188
Luoyang, Henan, 471003
Research Site 61
Nanchang, Jiangxi, 330006
Research Site 243
Shanghai, Shanghai Municipality, 200040
Research Site 189
Shanghai, Shanghai Municipality, 200050
Research Site 192
Suzhou, Jiangsu, 215002
Research Site 242
Tianjin, Tianjin Municipality, 300121
Research Site 60
Wenzhou, Zhejiang, 325000
Research Site 261
Wuhan, Hubei, 430060
Research Site 106
Xingtai, Hebei, 054099
Research Site 105
Yuncheng, Shanxi, 44000
Bulgaria18 sites
Research Site 187
Burgas, 8000
Research Site 100
Dimitrovgrad, 6400
Research Site 98
Kardzhali, 6600
Research Site 52
Kyustendil, 2500
Research Site 49
Pleven, 5800
Research Site 185
Plovdiv, 4001
Research Site 50
Plovdiv, 4002
Research Site 94
Rousse, 7013
Research Site 53
Sofia, 1404
Research Site 182
Sofia, 1431
Research Site 186
Sofia, 1431
Research Site 282
Sofia, 1510
Research Site 184
Sofia, 1527
Research Site 260
Sofia, 1582
Research Site 51
Sofia, 1616
Research Site 97
Sofia, 1618
Research Site 283
Sofia, 1756
Research Site 99
Stara Zagora, 6010
Poland16 sites
Research Site 78
Elblag, 82-300
Research Site 247
Gdynia, 81-338
Research Site 81
Katowice, 40-156
Research Site 141
Katowice, 40-752
Research Site 85
Katowice, 40-752
Research Site 83
Krakow, 31-501
Research Site 136
Lodz, 91-363
Research Site 131
Lodz, 94-255
Research Site 79
Lodz, 94-255
Research Site 80
Malbork, 82-200
Research Site 135
Szczecin, 71- 500
Research Site 84
Warsaw, 00-215
Research Site 216
Warsaw, 03-291
Research Site 267
Wroclaw, 53-030
Research Site 215
Zamość, 22-400
Research Site 82
Żarów, 58-130
Brazil15 sites
Research Site 181
Aracaju, Sergipe, 49055-530
Research Site 254
Belém, Pará, 66073-000
Research Site 178
Belo Horizonte, Minas Gerais, 30150-274
Research Site 255
Belo Horizonte, Minas Gerais, 30220-140
Research Site 257
Brasília, Federal District, 70710-100
Research Site 279
Campina Grande do Sul, 83430-000
Research Site 180
Campinas, São Paulo, 13060-080
Research Site 256
Canoas, Rio Grande do Sul, 92425-900
Research Site 296
Paranã, 80730-150
Research Site 259
Salvador, Estado de Bahia, 41810-010
Research Site 281
Salvador, 40170310
Research Site 280
Salvador, 40323-010
Research Site 177
São Paulo, 04266-010
Research Site 179
São Paulo, 05403-900
Research Site 176
Votuporanga, São Paulo, 15500-269
Czechia12 sites
Research Site 65
Hodonín, 69501
Research Site 197
Hradec Králové, 50005
Research Site 264
Náchod, 547 01
Research Site 118
Olomouc, CZ77900
Research Site 119
Prague, 11000
Research Site 66
Prague, 11000
Research Site 244
Prague, 140 21
Research Site 116
Praha 4-Krc, 140 59
Research Site 263
Slaný, 27401
Research Site 198
Teplice, 41501
Research Site 196
Trutnov, 541 01
Research Site 195
Ústí nad Labem, 40113
Argentina11 sites
Research Site 277
Buenos Aires, C1056ABI
Research Site 250
Ciudad Autonoma Buenos Aires, Buenos Aires, C1128AAF
Research Site 172
Ciudad Autonoma Buenos Aires, 1425
Research Site 276
Ciudad Autonoma Buenos Aires, C1417
Research Site 173
Ciudad Autonoma Buenos Aires, C1430CKE
Research Site 278
Córdoba, 5000
Research Site 171
Córdoba, X5000AAW
Research Site 239
Córdoba, X5006CBI
Research Site 240
Córdoba, X5008HHW
Research Site 251
Ramos Mejía, Buenos Aires, B1704ETD
Research Site 249
Rosario, 2000
Canada11 sites
Research Site 6
Chicoutimi, Quebec, G7H 7K9
Research Site 103
Halifax, Nova Scotia, NS B3H 1V7
Research Site 56
Kitchener, N2H5Z8
Research Site 7
London, Ontario, N6A 5K8
Research Site 5
Montreal, Quebec, H2W 1R7
Research Site 4
Québec, Quebec, G1V 4W2
Research Site 19
Québec, G1G5X1
Research Site 55
Sarnia, Ontario, N7T 4X3
Research Site 241
Toronto, Ontario, M5G 2C4
Research Site 20
Victoria, British Columbia, V8T5G4
Research Site 102
Waterloo, Ontario, N2T 0C1
Hungary9 sites
Research Site 204
Budapest, 1033
Research Site 123
Budapest, 1051
Research Site 68
Budapest, 1132
Research Site 265
Budapest, 1152
Research Site 205
Miskolc, 3530
Research Site 67
Pécs, 7623
Research Site 286
Szeged, 6725
Research Site 202
Veszprém, 8200
Research Site 203
Zalaegerszeg, 8900
South Africa8 sites
Research Site 222
Cape Town, Western Cape, 7500
Research Site 220
Cape Town, Western Cape, 7570
Research Site 221
Cape Town, Western Cape, 7925
Research Site 288
Cape Town, 7530
Research Site 219
Krugersdorp, Gauteng, 1739
Research Site 269
Mossel Bay, Western Cape, 6500
Research Site 270
Pretoria, Gauteng, 0181
Research Site 149
Somerset West, Western Cape, 7130
Spain8 sites
Research Site 224
A Coruña, La Coruña, 15006
Research Site 271
Barcelona, 08023
Research Site 223
Barcelona, 08035
Research Site 226
Madrid, 28041
Research Site 289
Santiago de Compostela, 15706
Research Site 150
Seville, 41013
Research Site 225
Valencia, 46010
Research Site 151
Zaragoza, 50009
Belgium7 sites
Research Site 48
Gozée, 6534
Research Site 87
Hasselt, 3500
Research Site 90
Mechelen, 97770
Research Site 46
Namur, 5000
Research Site 89
Namur, 5380
Research Site 175
Roeselare, 8800
Research Site 45
Wetteren, 9230
Italy6 sites
Research Site 245
Bologna, 40138
Research Site 208
Brescia, 25123
Research Site 207
Milan, 20162
Research Site 210
Palermo, 90127
Research Site 206
Roma, 00168
Research Site 209
Rozzano, Milano, 20089
Slovakia6 sites
Research Site 268
Banská Bystrica, 97401
Research Site 147
Bardejov, 08501
Research Site 146
Košice, 04001
Research Site 218
Moldava nad Bodvou, 045 01
Research Site 248
Nitra, 950 01
Research Site 148
Rožňava, 048 01
Latvia5 sites
Research Site 212
Daugavpils, LV-5410
Research Site 124
Daugavpils, LV-5417
Research Site 211
Riga, LV-1002
Research Site 287
Riga, LV-1038
Research Site 69
Riga, LV1063
Lithuania5 sites
Research Site 70
Kaunas, 49387
Research Site 246
Kaunas, 49449
Research Site 213
Kaunas, LT-50177
Research Site 127
Šiauliai, LT-76206
Research Site 214
Vilnius, LT-08661
Romania5 sites
Research Site 142
Bucharest, 010192
Research Site 217
Galati, 800291
Research Site 143
Ploieşti, 100342
Research Site 144
Târgu Mureş, 540136
Research Site 145
Timișoara, 300362
Australia4 sites
Research Site 86
Box Hill, Victoria, 3128
Research Site 253
Clayton, Victoria, 3168
Research Site 252
Heidelberg Heights, Victoria, 3081
Research Site 174
Nedlands, Western Australia, 6009
France3 sites
Research Site 199
Marseille, Bouches-du-Rhône, 13005
Research Site 200
Paris, Paris, 75013
Research Site 120
Pessac, Gironde, 33604
Germany3 sites
Research Site 285
Berlin, 13353
Research Site 284
Deggingen, 73326
Research Site 201
Magdeburg, Saxony-Anhalt, 39120
Japan3 sites
Research Site
Bunkyo-Ku, Tokyo, 113-0033
Research Site
Chiba, 260-8677
Research Site
Shimotsuke-shi, Tochigi, 329-0498
United Kingdom3 sites
Research Site 227
London, Greater London, EC1M 6BQ
Research Site 71
Plymouth, Devon, PL5 3JB
Research Site 153
Torquay, Devon, TQ2 7AA
Croatia2 sites
Research Site 262
Karlovac, 47000
Research Site 194
Zagreb, 10000
New Zealand2 sites
Research Site 128
Christchurch, 08011
Research Site 129
Wellington, 6021
About this study
Official title: 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.
Read more
Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria:
- HbA1c ≤10% within 30 days prior to Day 1
- Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d)
- 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
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.
- Conditions
- Hypertriglyceridemia
- Being tested
- Plozasiran Injection
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plozasiran InjectionDrug
Also called ARO-APOC3
ARO-APOC3 injection
| Study group | Role | What they receive |
|---|---|---|
| Plozasiran Injection | Experimental | 8 doses of plozasiran (ARO-APOC3) administered by subcutaneous (SC) injection Receives: Drug: Plozasiran Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: From first dose of study drug through Month 24
Secondary outcomes (20)
Change from Baseline Over Time in Fasting Serum Triglyceride (TG) Levels
Measured: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting Serum TG Levels
Measured: From first dose of study drug through Month 24
Change from Baseline Over Time in Apolipoprotein CIII (APOC3)
Measured: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in APOC3
Measured: From first dose of study drug through Month 24
Change from Baseline Over Time in Remnant Cholesterol
Measured: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Remnant Cholesterol
Measured: From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Measured: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting non-HDL-C
Measured: From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting High-Density Lipoprotein Cholesterol (HDL-C)
Measured: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting HDL-C
Measured: From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Total Apolipoprotein B (Apo B)
Measured: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting Total Apo B
Measured: From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) using Ultracentrifugation
Measured: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting LDL-C using Ultracentrifugation
Measured: From first dose of study drug through Month 24
Change from Baseline Over Time in Hemoglobin A1c (HbA1c)
Measured: From first dose of study drug through Month 24
Number of Participants With Emergent Apheresis
Measured: From first dose of study drug through Month 24
Adjudicated Major Adverse Cardiovascular Event Rates During the Treatment Period
Measured: From first dose of study drug through Month 24
Incidence of Anti-Drug Antibodies (ADA) to Plozasiran Over Time
Measured: From first dose of study drug through Month 24
Titers of ADA to Plozasiran Over Time
Measured: From first dose of study drug through Month 24
Adjudicated Acute Pancreatitis (AP) Event Rate During the Treatment Period
Measured: From first dose of study drug through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start9 Apr 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 710 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822790
- Sponsor's protocol ID
- AROAPOC3-3006
- Acronym
- SHASTA-10
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No