Plozasiran: ARO-APOC3 injection
Placebo: sterile normal saline (0.9% NaCl)
This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Los Angeles | California | Recruiting |
| Clinical Research Site 4 | Santa Clarita | California | Recruiting |
| Research Site | New Haven | Connecticut | Recruiting |
| Clinical Research Site 6 | Springfield | Illinois | Recruiting |
| Research Site | Indianapolis | Indiana | Recruiting |
| Research Site | Kansas City | Kansas | Recruiting |
| Research Site | Ann Arbor | Michigan | Recruiting |
| Research Site | St Louis | Missouri | Recruiting |
| Clinical Research Site 5 | North Platte | Nebraska | Recruiting |
| Research Site | New York | New York | Recruiting |
| Clinical Research Site 3 | Greensboro | North Carolina | Recruiting |
| Research Site | Wilmington | North Carolina | Recruiting |
| Clinical Research Site 7 | Philadelphia | Pennsylvania | Recruiting |
| Research Site | Pittsburgh | Pennsylvania | Recruiting |
| Clinical Research Site 1 | Mesquite | Texas | Recruiting |
| Clinical Research Site 2 | San Antonio | Texas | Recruiting |
| Research Site | Seattle | Washington | Recruiting |
| Research Site | Ramos Mejía | Buenos Aires | Recruiting |
| Research Site | Córdoba | Córdoba Province | Recruiting |
| Research Site | Córdoba | Córdoba Province | Recruiting |
| Research Site | Rosario | Santa Fe Province | Recruiting |
| Research Site | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Research Site | Graz | Austria | Recruiting |
| Research Site | Linz | Austria | Recruiting |
| Research Site | Vienna | Austria | Recruiting |
| Research Site | Fortaleza | Ceará | Recruiting |
| Research Site | Belo Horizonte | Minas Gerais | Recruiting |
| Research Site | Belo Horizonte | Minas Gerais | Recruiting |
| Research Site | Belo Horizonte | Minas Gerais | Recruiting |
| Research Site | Curitiba | Paraná | Recruiting |
| Research Site | Porto Alegre | Rio Grande do Sul | Recruiting |
| Research Site | Porto Alegre | Rio Grande do Sul | Recruiting |
| Research Site | Pôrto Alegre | Rio Grande do Sul | Recruiting |
| Research Site | São Paulo | São Paulo | Recruiting |
| Research Site | São Paulo | São Paulo | Not Yet Recruiting |
| Research Site | São Paulo | Brazil | Recruiting |
| Research Site | Burgas | Bulgaria | Recruiting |
| Research Site | Pleven | Bulgaria | Recruiting |
| Research Center | Plovdiv | Bulgaria | Recruiting |
| Research Site | Plovdiv | Bulgaria | Recruiting |
+ 81 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06880770 on ClinicalTrials.gov ↗ ← All trials in China