[Translation] A randomized, double-blind, multiple-dose, placebo-controlled phase II clinical study on the efficacy and safety of CVI-LM001 tablets in subjects with hypercholesterolemia
主要目的:在原发性高血脂受试者中初步评估不同剂量组CVI-LM001和安慰剂相比,在12周的治疗后LDL-C 较基 线的下降率;初步评估不同剂量组CVI-LM001的安全性和耐受性。 次要目的:在原发性高血脂受试者中,初步评估不同剂量组CVI-LM001与安慰剂相比对以下各项因素的影响 :治疗第 2、4、8、12 周的 TC、TG、HDL-C、non-HDL-C 、ApoB、ApoA1、Lp(a)、hsCRP、PCSK9较基线变化率;第2、4、8周的LDL-C下降率。
[Translation] Primary objective: To preliminarily evaluate the reduction rate of LDL-C from baseline after 12 weeks of treatment in subjects with primary hyperlipidemia in different dose groups of CVI-LM001 compared with placebo; to preliminarily evaluate the safety and tolerability of CVI-LM001 in different dose groups. Secondary objective: To preliminarily evaluate the effects of CVI-LM001 in different dose groups compared with placebo on the following factors in subjects with primary hyperlipidemia: the change rate of TC, TG, HDL-C, non-HDL-C, ApoB, ApoA1, Lp(a), hsCRP, PCSK9 from baseline at 2, 4, 8, and 12 weeks of treatment; the reduction rate of LDL-C at 2, 4, and 8 weeks.