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This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continued to meet eligibility criteria had the option to be enrolled into this study. Eligible enrolled participants initially received open-label ARO-APOC3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARO-APOC3 | Experimental | 1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARO-APOC3 | Drug | ARO-APOC3 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Through 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Fasting Triglycerides (TG) Over Time | Through 24 months | |
| Percent Change from Baseline in Fasting TG Over Time | Through 24 months | |
| Change from Baseline in Apolipoprotein (Apo) C-III Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site 1 | Beverly Hills | California | 90211 | United States | ||
| Clinical Research Site 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42291067 | Derived | Ballantyne CM, Baass A, Rosenson RS, Hegele RA, Nicholls SJ, Vasas S, Clifton P, Lucas KJ, Pall D, Zhou R, Leeper NJ, Hellawell J, Aiyer L, Watts GF, Gaudet D. Use of plozasiran across a spectrum of hypertriglyceridemia: Long-term efficacy and safety data from the open-label extension period of SHASTA-2 and MUIR Trials. Am J Prev Cardiol. 2026 Mar 24;27:101523. doi: 10.1016/j.ajpc.2026.101523. eCollection 2026 Jun. |
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| Through 24 months |
| Percent Change from Baseline in ApoC-III Over Time | Through 24 months |
| Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time | Through 24 months |
| Percent Change from Baseline in Fasting Non-HDL-C Over Time | Through 24 months |
| Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time | Through 24 months |
| Percent Change from Baseline in Fasting HDL-C Over Time | Through 24 months |
| Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time | Through 24 months |
| Percent Change from Baseline in Fasting Total ApoB Over Time | Through 24 months |
| Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation | Through 24 months |
| Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation | Through 24 months |
| Northridge |
| California |
| 91325 |
| United States |
| Clinical Research Site 3 | Palm Springs | California | 92292 | United States |
| Clincal Research Site 4 | Boca Raton | Florida | 33434 | United States |
| Clinical Research Site 5 | Fort Lauderdale | Florida | 33308 | United States |
| Clinical Research Site 8 | Miami | Florida | 33155 | United States |
| Clinical Research Site 6 | Miami | Florida | 33173 | United States |
| Clinical Research Site 9 | Miami Springs | Florida | 33166 | United States |
| Clinical Research Site 10 | Pembroke Pines | Florida | 33024 | United States |
| Clinical Research Site 11 | Port Orange | Florida | 32127 | United States |
| Clinical Research Site 12 | Dunwoody | Georgia | 30338 | United States |
| Clinical Research Site 13 | Minneapolis | Minnesota | 55455 | United States |
| Clinical Research Site 14 | Tupelo | Mississippi | 38801 | United States |
| Clinical Research Site 15 | Omaha | Nebraska | 68114 | United States |
| Clinical Research Site 16 | Las Vegas | Nevada | 89121 | United States |
| Clinical Research Site 17 | Long Island City | New York | 11106 | United States |
| Clinical Research Site 18 | New Windsor | New York | 12553 | United States |
| Clinical Research Site 19 | New York | New York | 10029 | United States |
| Clinical Research Site 20 | Morehead City | North Carolina | 28557 | United States |
| Clinical Research Site 21 | Fargo | North Dakota | 58104 | United States |
| Clinical Research Site 22 | Marion | Ohio | 43302 | United States |
| Clinical Research Site 23 | Maumee | Ohio | 43537 | United States |
| Clinical Research Site 24 | Oklahoma City | Oklahoma | 73135 | United States |
| Clinical Research Site 25 | Greenville | South Carolina | 29607 | United States |
| Clinical Research Site 26 | Chattanooga | Tennessee | 37421 | United States |
| Clinical Research Site 29 | Houston | Texas | 77002 | United States |
| Clinical Research Site 27 | Houston | Texas | 77030 | United States |
| Clinical Research Site 28 | Houston | Texas | 77099 | United States |
| Clinical Research Site 30 | San Antonio | Texas | 78249 | United States |
| Clinical Research Site 31 | Manassas | Virginia | 20110 | United States |
| Clinical Research Site 32 | Camperdown | New South Wales | 2050 | Australia |
| Clinical Research Site 33 | Milton | Queensland | 4068 | Australia |
| Clinical Research Site 34 | Sippy Downs | Queensland | 4556 | Australia |
| Clinical Research Site 35 | Adelaide | South Australia | 5000 | Australia |
| Clinical Research Site 36 | Clayton | Victoria | 3168 | Australia |
| Clinical Research Site 37 | Joondalup | Washington | 6027 | Australia |
| Clinical Research Site 38 | Nedlands | Washington | 6009 | Australia |
| Clinical Research Site 39 | Concord | Ontario | L4K4M2 | Canada |
| Clinical Research Site 40 | London | Ontario | N6A 5A5 | Canada |
| Clinical Research Site 41 | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Clinical Research Site 43 | Montreal | Quebec | H2W 1R7 | Canada |
| Clinical Research Site 44 | Québec | Quebec | G1G 3Z4 | Canada |
| Clinical Research Site 46 | Balatonfüred | H-8230 | Hungary |
| Clinical Research Site 47 | Békéscsaba | 5600 | Hungary |
| Clinical Research Site 48 | Debrecen | 4032 | Hungary |
| Clinical Research Site 49 | Gyöngyös | 3200 | Hungary |
| Clinical Research Site 50 | Komárom | H-2900 | Hungary |
| Clinical Research Site 51 | Nyíregyháza | 4400 | Hungary |
| Clinical Research Site 53 | Amsterdam | 1105 AZ | Netherlands |
| Clinical Research Site 54 | Sneek | 8601 ZR | Netherlands |
| Clinical Research Site 55 | Zwijndrecht | 3331LZ | Netherlands |
| Clinical Research Site 58 | Papatoetoe | Aukland | 2025 | New Zealand |
| Clinical Research Site 56 | Christchurch | 8011 | New Zealand |
| Clinical Research Site 57 | Christchurch | 8013 | New Zealand |
| Clinical Research Site 59 | Bydgoszcz | 85-605 | Poland |
| Clinical Research Site 64 | Lodz | 93-338 | Poland |
| Clinical Research Site 63 | Lodz | 94 046 | Poland |
| Clinical Research Site 60 | Oświęcim | 32-600 | Poland |
| Clinical Research Site 61 | Poznan | 61-655 | Poland |
| Clinical Research Site 62 | Rzeszów | 35-055 | Poland |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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