[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy, safety and pharmacokinetic characteristics of ZX2021 injection in non-diabetic overweight or obese subjects
主要目的:初步评价不同剂量ZX2021注射液相比于安慰剂在非糖尿病的超重或肥胖受试者中的有效性。
次要目的:评价不同剂量ZX2021注射液相比于安慰剂在非糖尿病的超重或肥胖受试者中的安全性和耐受性;评价不同剂量ZX2021注射液相比于安慰剂在非糖尿病的超重或肥胖受试者中的药代动力学特征;评价不同剂量ZX2021注射液相比于安慰剂在非糖尿病的超重或肥胖受试者中的免疫原性特征。
探索性目的:探索性评价ZX2021注射液对非糖尿病的超重或肥胖受试者的体脂、瘦体重、骨密度等的影响。
[Translation] Primary objective: To preliminarily evaluate the effectiveness of different doses of ZX2021 injection compared with placebo in non-diabetic overweight or obese subjects.
Secondary objective: To evaluate the safety and tolerability of different doses of ZX2021 injection compared with placebo in non-diabetic overweight or obese subjects; to evaluate the pharmacokinetic characteristics of different doses of ZX2021 injection compared with placebo in non-diabetic overweight or obese subjects; to evaluate the immunogenicity characteristics of different doses of ZX2021 injection compared with placebo in non-diabetic overweight or obese subjects.
Exploratory objective: To explore the effects of ZX2021 injection on body fat, lean body mass, bone density, etc. in non-diabetic overweight or obese subjects.