SHASTA-3
Trial Overview
Official Title
DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PLOZASIRAN IN ADULTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHASTA-3 STUDY)
Study Purpose
To demonstrate the efficacy of plozasiran on reducing fasting serum triglyceride levels.
Diagnosis
Mean triglycerides level ≥ 500 mg/dL; fasting LDL ≤ 130 mg/dLEligibility
- Willing to follow diet counseling and maintain a stable low-fat diet.
Exclusion - Use of siRNA within the last year aimed at treating triglycerides
- Known familial chylomicronemia syndrome
- BMI > 45
- Acute pancreatitis within 4 weeks of screening
Intervention
Plozasiran vs placebo
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Key Participation Requirements
Trial Location(s)
Gender
All
Age
19+
Enrollment Status
Recruiting
Phase
Phase III
Methodist Health System Trial Code
NCT06347003