Borui Xinchuang Biomedical Technology (Wuxi) Co., Ltd

Main purpose: 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 doses for 4 weeks (Phase 1). Secondary purpose: To evaluate the safety, efficacy and immunogenicity characteristics of BGM0504 injection administered subcutaneously for 20 weeks in non-diabetic overweight or obese subjects for weight control (Phase 2).

Main purpose: To evaluate the safety and tolerability of subcutaneous injection of BGM0504 injection in patients with type 2 diabetes mellitus for multiple administrations. Secondary objective: To evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of BGM0504 injection in patients with type 2 diabetes mellitus after multiple subcutaneous injections. Preliminary comparison of the efficacy and safety of BGM0504 injection and semaglutide injection in patients with type 2 diabetes by multiple subcutaneous injections.

Main purpose: To evaluate the safety and tolerability of single administration of BGM0504 injection in healthy volunteers and gradual administration once a week to the target dose; to evaluate the single administration and daily administration of BGM0504 injection in healthy volunteers Pharmacokinetic characteristics of weekly administration to target dose. Secondary purpose: To preliminarily evaluate the pharmacodynamic characteristics of BGM0504 injection in healthy volunteers after single administration and weekly administration to the target dose.