769-P: Bofanglutide (GZR18), a Novel GLP-1RA, Improved Glycemic Control and Cardiometabolic Risk Factors in Chinese Patients with T2D

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Introduction and Objective: This randomized, double-blind, placebo-controlled, dose-escalation phase 2a trial aimed to assess the safety and efficacy of a novel GLP-1 RA, bofanglutide (GZR18), in Chinese adults with T2D. Methods: Thirty-six adults with T2D inadequately controlled with lifestyle management and/or non-compliance with OADs were randomized 3:1 to receive either GZR18 or placebo once-weekly for 23 weeks, with a dose escalating from 1.5 mg to 13 mg. Safety endpoints, including treatment-emergent adverse events (TEAEs) and gastrointestinal AEs, were evaluated. Key efficacy endpoint was HbA1c change from baseline to week 23. Results: By week 23, the GZR18 group exhibited a greater reduction in HbA1c of -1.81 % compared to 0.12 % in the placebo group, along with significant reductions in body weight (-9.25 %), waist circumstance (-5.31 cm), SBP (-15.4 mmHg) and blood lipids. The most common TEAEs were Grade 1-2 gastrointestinal AEs. No hypoglycemia or serious adverse events related to GZR18 were observed. Conclusion: GZR18 was well-tolerated in Chinese patients with T2D, demonstrating significant HbA1c reductions alongside comprehensive benefits for body weight, blood pressure and blood lipid profiles. These findings further support the exploration of GZR18's dosing frequency in the phase 2b trial and cardiometabolic outcomes in future GZR18 clinical trials. Disclosure W. Li: None. M. Liu: None. R. Dong: None. X. Wang: None. J. Zhao: None. L. Zhao: None. A. He: None. T. Xie: None. Y. Li: None. H. Wu: None. S. Carter: None. Z. Gan: None. W. Chen: None.

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