[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy and safety of HRS-7249 and SHR-1918 in patients with severe hypertriglyceridemia at high risk of acute pancreatitis.
主要目的
评价HRS-7249、SHR-1918与安慰剂相比,在急性胰腺炎高风险的重度高甘油三酯血症患者中降低TG的有效性和预防AP的有效性。
次要目的
评价HRS-7249、SHR-1918与安慰剂相比,在急性胰腺炎高风险的重度高甘油三酯血症患者中对发生AP的影响;
评价HRS-7249、SHR-1918与安慰剂相比,在急性胰腺炎高风险的重度高甘油三酯血症患者中改善其他血脂指标的有效性;
评价HRS-7249、SHR-1918与安慰剂相比,在急性胰腺炎高风险的重度高甘油三酯血症患者中的群体药代动力学和药效学特征;
评价HRS-7249、SHR-1918与安慰剂相比,在急性胰腺炎高风险的重度高甘油三酯血症患者中的免疫原性。
[Translation] Primary Objectives:
Evaluate the efficacy of HRS-7249 and SHR-1918, compared with placebo, in reducing triglycerides and preventing acute pancreatitis (AP) in patients with severe hypertriglyceridemia at high risk.
Secondary Objectives:
Evaluate the effect of HRS-7249 and SHR-1918, compared with placebo, on the occurrence of AP in patients with severe hypertriglyceridemia at high risk of acute pancreatitis;
Evaluate the efficacy of HRS-7249 and SHR-1918, compared with placebo, in improving other lipid parameters in patients with severe hypertriglyceridemia at high risk of acute pancreatitis;
Evaluate the population pharmacokinetic and pharmacodynamic characteristics of HRS-7249 and SHR-1918, compared with placebo, in patients with severe hypertriglyceridemia at high risk of acute pancreatitis;
Evaluate the immunogenicity of HRS-7249 and SHR-1918, compared with placebo, in patients with severe hypertriglyceridemia at high risk of acute pancreatitis.