SHASTA-3/4
SHASTA-3 and SHASTA-4 — Double-blind, Placebo-controlled, Phase 3 Studies to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 757 patients with severe hypertriglyceridaemia, plozasiran every 3 months was compared with placebo on the change in fasting triglycerides at 12 months.
N
757
Schéma
Two identically designed multinational, randomised, double-blind (quadruple-masked), placebo-controlled, parallel-group phase 3 trials; 2:1 allocation to plozasiran or placebo; four quarterly subcutaneous injections over a 12-month double-blind period, then post-treatment evaluation or open-label extension; randomisation stratified by baseline triglyceride level and acute pancreatitis within 5 years; primary completion June 2026.
Critère
Placebo-adjusted percent change in fasting serum triglycerides from baseline to month 12