[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of multiple subcutaneous injections of SHR-1918 injection combined with lipid-lowering drugs in the stable treatment of hyperlipidemia patients with poor blood lipid control
主要研究目的:
评价与安慰剂相比,多次皮下注射SHR-1918注射液治疗16周后,高脂血症患者LDL-C相对于基线变化的百分比。
次要研究目的:
评价与安慰剂相比,多次皮下注射SHR-1918注射液治疗16周后,高脂血症患者TG相对于基线变化的百分比;
评价多次皮下注射SHR-1918在高脂血症患者中的安全性、药代动力学和药效学特征和免疫原性。
[Translation] Primary study objectives:
To evaluate the percentage change of LDL-C from baseline in patients with hyperlipidemia after 16 weeks of treatment with multiple subcutaneous injections of SHR-1918 injection compared with placebo.
Secondary study objectives:
To evaluate the percentage change of TG from baseline in patients with hyperlipidemia after 16 weeks of treatment with multiple subcutaneous injections of SHR-1918 injection compared with placebo;
To evaluate the safety, pharmacokinetic and pharmacodynamic characteristics and immunogenicity of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia.