Phase 3Active, not recruiting
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10)
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10 Study)
- Sponsor
- Arrowhead Pharmaceuticals (Industry)
- Enrolment
- 710 enrolled
- Conditions
- Hypertriglyceridemia
- Interventions
- Plozasiran Injection
- Ages
- adults, older adults
- Registry
- NCT06822790
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
History
Primary completion expected
Last registry update
Started
Registered