[Translation] A double-blind, placebo-controlled, Phase III study evaluating the efficacy and safety of plozasiran in adult patients with severe hypertriglyceridemia (SHASTA-3 study).
主要目的:证明Plozasiran在降低空腹血清TG水平方面的疗效。 次要目的:达到TG水平降低目标的受试者比例;评价Plozasiran在裁定的腹部临床事件发生率方面的疗效。
安全性目的:评价Plozasiran的安全性和耐受性;评价裁定的重大心血管不良事件发生率;评价试验用药品的免疫原性)评价Plozasiran对肝脏脂肪含量的影响。 探索性目的:证明Plozasiran在血脂相关指标变化方面的疗效; 评价Plozasiran对血液中心血管代谢疾病相关炎症和探索性血清生物标志物的影响。
[Translation] Primary objective: To demonstrate the efficacy of Plozasiran in reducing fasting serum TG levels. Secondary objectives: The proportion of subjects who achieved the target TG level reduction; To evaluate the efficacy of Plozasiran in the incidence of adjudicated abdominal clinical events.
Safety objectives: To evaluate the safety and tolerability of Plozasiran; To evaluate the incidence of adjudicated major adverse cardiovascular events; To evaluate the immunogenicity of the trial drug) To evaluate the effect of Plozasiran on liver fat content. Exploratory objectives: To demonstrate the efficacy of Plozasiran in changes in lipid-related indicators; To evaluate the effects of Plozasiran on inflammation and exploratory serum biomarkers related to cardiovascular and metabolic diseases in the blood.