752-P: Efficacy and Safety of Bofanglutide (GZR18), a Biweekly GLP-1RA, Compared with Semaglutide in Chinese Patients with T2D

Introduction and Objective: Efforts have focused on developing GLP-1 RAs with less frequent dosing to improve patient acceptance and adherence in managing T2D. This randomized, open-label, phase 2b trial aimed to evaluate the efficacy and safety of a novel bi-weekly (Q2W) GLP-1 RA, bofanglutide (GZR18), compared to once-weekly (QW) semaglutide (SEMA, Ozempic®) in Chinese patients with T2D. Methods: A total of 272 eligible adult patients (HbA1c 7-11%) who were drug-naïve or on stable treatment with OADs were randomized 1:1:1:1:1 into one of four GZR18 groups (12, 18, 24 mg Q2W and 24 mg QW) or the SEMA group (1 mg QW) for 24 weeks. The primary endpoint was HbA1c change from baseline to week 24. Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs). Results: The LSM HbA1c reductions were greater in GZR18 groups (-1.87% to -2.32%) than in the SEMA group (-1.6%), with significant treatment differences in two GZR18 groups (18 mg Q2W and 24 mg QW) vs. SEMA (P<0.001). GZR18 also surpassed SEMA in most secondary efficacy measures, including body weight. The most common TEAEs were Grade 1-2 gastrointestinal AEs. No Grade 3 or higher AEs or severe hypoglycemia were related to GZR18. Conclusion: In Chinese patients with T2D, GZR18 Q2W showed a comparable or superior HbA1c and weight reduction than SEMA 1mg QW. This study warrants phase 3 trials of bi-weekly dosing of GZR18 in treating T2D. Disclosure H. Wu: None. M. Liu: None. Z. Cheng: None. L. Lu: None. H. Cai: None. J. Liu: None. J. Liu: None. Y. Zheng: None. S. Wang: None. J. Zhao: None. W. Yang: None. T. Xie: None. Y. Li: None. A. He: None. S. Carter: None. W. Chen: None. Z. Gan: None.