[Translation] A randomized, double-blind, placebo-controlled, parallel-group Phase II clinical study to evaluate the safety, tolerability, PK/PD characteristics and efficacy of BGM0504 injection after multiple doses in non-diabetic overweight or obese subjects
主要目的:评估BGM0504 注射液在非糖尿病的超重或肥胖受试者中滴定给药后目标剂量连续给药 4 周的安全性、 耐受性及PK/PD特征(第一阶段) 。
次要目的:评估BGM0504 注射液在非糖尿病的超重或肥胖受试者中皮下注射连续给药 20 周用于体重控制的安全性、 有效性及免疫原性特征(第二阶段)。
[Translation] Primary objective: To evaluate the safety, tolerability and PK/PD characteristics of BGM0504 injection in non-diabetic overweight or obese subjects after titration and continuous administration of target dose for 4 weeks (Phase I).
Secondary objective: To evaluate the safety, efficacy and immunogenicity of BGM0504 injection in non-diabetic overweight or obese subjects for weight control by subcutaneous injection for 20 weeks (Phase II).