839-P: Efficacy and Safety of HDG1901 vs. Ozempic in Patients with Type 2 Diabetes (T2D)—A Randomized, Open-Label, Bioequivalence Phase 3 Trial

Introduction and Objective: HDG1901 is a biosimilar of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA). The efficacy and safety of HDG1901 as compared with the the reference semaglutide (Ozempic®) was investigated in a Phase 3 trial. Methods: A total of 490 participants were randomized in a 1:1 ratio to receive weekly dose of either HDG1901 or reference semaglutide for 32 weeks, including 8-week titration and 24-week maintenance treatment at 1mg. Participants with the glycosylated hemoglobin (HbA1c) between 7 and 10.5 % and age of 18-75 years were enrolled. The primary endpoint was the change from baseline in HbA1c at week 32. Results: The least square mean changes from baseline in the HbA1c at Week 32 was -2.047% for HDG1901 group (N=245) and -2.008% for reference semaglutide group (N=245). The treatment difference between this two group was -0.038, the upper and lower bound of the 95% confidence interval for treatment difference was within the equivalence margin of 0.4 % (95%CI: -0.189, 0.112 ). At Week 32, the least square mean changes from baseline in bodyweight was -4.094kg for HDG1901 group and -4.346kg for reference semaglutide group. The incidence of treatment-emergent adverse events (TEAEs) for HDG1901 and reference semaglutide was 81.7% and 90.3%, respectively. High incidence of gastrointestinal related TEAEs were reported in the HDG1901 and reference semaglutide groups (nausea, 9.3% and 14.6%; diarrhea, 16.7% and 17.0%; and vomiting, 7.7% and 9.3%), and were primarily mild to moderate. A minority of participants (2.0% and 2.8%) discontinued treatment due to TEAEs in the HDG1901 and reference semaglutide groups, respectively. Conclusion: In patients with T2D, HDG1901 was equivalent to reference semaglutide with respect to the mean changes from baseline in HbA1c at 32 weeks. HDG1901 was generally well tolerated in this population. It offers an option for the treatment of T2D (ClinicalTrials.gov identifier: NCT06739044). Disclosure L. Guo: Research Support; Abbott, AstraZeneca, Bayer Pharmaceuticals, Inc, Eli Lilly and Company, Innovent Biologics, Merck & Co., Inc, MSD Life Science Foundation, Novo Nordisk A/S, Sanofi, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Tonghua Dongbao. S. Pang: None. Z. Cheng: None. J. Song: Research Support; HuaDong Pharmaceutical Co.,Ltd. H. Ling: None. X. Shi: None. L. Zhang: None. X. Wang: Employee; HuaDong Pharmaceutical Co., Ltd. H. Gao: Employee; HuaDong Pharmaceutical Co. Ltd. L. Shen: Employee; HuaDong Pharmaceutical Co., Ltd. L. Zhong: Employee; HuaDong Pharmaceutical Co.,Ltd. J. Xu: None.