Evaluation of the Safety, Efficacy and Pharmacokinetics of BGM0504 in Chinese Adults With Type 2 Diabetes: A Multicentre, Randomised, Controlled and Double-Blind Phase II Trial.

AIM: This study aimed to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy in Chinese adults with T2DM and to preliminarily compare its efficacy and safety with semaglutide through multiple subcutaneous injections. MATERIALS AND METHODS: In this multicentre, randomised, placebo-controlled and semaglutide-positive-controlled trial, 64 Chinese adults with T2DM were randomly assigned to BGM0504 5 mg (n = 12), 10 mg (n = 12), 15 mg (n = 12), placebo (n = 12) or semaglutide 1 mg (n = 16). All participants received their assigned dose once weekly for 12 weeks. The primary endpoint was the change in HbA1c from baseline, and secondary endpoints included fasting plasma glucose (FPG), 2-h plasma glucose (2 h PG) and body weight. Safety was assessed through adverse events, laboratory tests and vital signs. RESULTS: At Week 12, the mean changes in HbA1c from baseline were -1.72% for the 5 mg dose, -1.94% for the 10 mg dose, -2.48% for the 15 mg dose, -1.43% for 1 mg semaglutide and 0.28% for placebo, with the treatment differences versus placebo (LSM) ranging from -1.82% to -2.56% (all p < 0.05). The proportion of participants achieving HbA1c < 6.5% or < 7.0% increased in a dose-dependent manner. BGM0504 also shows a signal for lowering FPG, 2 h PG and body weight (all p < 0.05), with the 15 mg dose showing superior weight reduction to semaglutide. Pharmacokinetics analysis confirmed a linear exposure-response relationship. All doses were well tolerated, with mostly mild adverse events. CONCLUSION: BGM0504 shows a signal reduction for HbA1c, FPG, 2 h PG and body weight in Chinese adults with T2DM. The 12-week treatment with BGM0504 was safe and well-tolerated, with the 15 mg dose showing the most substantial effects.