Calendario›ARWR›Plozasiran Injection · SHASTA-10
Plozasiran Injection · SHASTA-10
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
Ensayo de ARROWHEAD PHARMACEUTICALS, INC. en Hipertrigliceridemia.
Más ensayos de: Hipertrigliceridemia.
- Fase
- Fase 3
- Estado
- En marcha, sin reclutar
- Participantes
- 710
- Centros
- 253
- Fin del objetivo primario
- jul 2028
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2025.
Lo que ha cambiado
Movimientos registrados desde que PivotalWire vigila este ensayo. Un retraso no se anuncia: se ve comparando, y esto es la comparación ya hecha.
| Visto | Qué se mueve | Cambio |
|---|---|---|
| 2 oct 2026 | Estado | Reclutando pacientes → En marcha, sin reclutar |
Qué mide
Numero de participantes con acontecimientos adversos surgidos del tratamiento (TEAE) (From first dose of study drug through Month 24) (del registro, en inglés)
Qué se prueba
Los participantes recibirán plozasiran por vía subcutánea aproximadamente cada 3 meses durante 24 meses.
Lo que dice el documentoAll 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.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis 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.
Más ensayos de ARWR
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Plozasiran Injection · SHASTA-3 | Fase 3 | En marcha, sin reclutar | jun 2026 (real) |
| Plozasiran Injection · SHASTA-4 | Fase 3 | En marcha, sin reclutar | jun 2026 (real) |
| ARO-DIMERPA | Fase 1/2 | Reclutando pacientes | sep 2026 (prevista, ya pasada: sin actualizar en el registro) |
| ARO-ATXN2 Injection | Fase 1 | En marcha, sin reclutar | dic 2026 (prevista) |
| ARO-ALK7 | Fase 1/2 | Reclutando pacientes | feb 2027 (prevista) |
| ARO-MAPT-SC | Fase 1/2 | Reclutando pacientes | jun 2027 (prevista) |
Todos los de ARWR, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06822790), actualizada en sep 2026.