A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise. The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
• ☑ Have been diagnosed with type 2 diabetes mellitus (T2DM);
‣ Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
⁃ Be of stable weight (± 5%) for at least 3 months before screening;
⁃ Have HbA1c between ≥7.5% and ≤11.0%；
⁃ Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.