CVI Pharmaceuticals (Shanghai) Co Ltd

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.

Primary purpose: To study the safety of CVI-LM001 after multiple administrations in subjects with hyperlipidemia through a randomized, double-blind, placebo-controlled parallel trial. Secondary purpose: To study the pharmacokinetic characteristics and drug effects of CVI-LM001 after multiple administrations in subjects with hyperlipidemia, and to provide a basis for formulating the experimental plan for Phase II clinical trials.