Zhitong Finance App News, Borui Pharmaceutical (688166.SH) issued an announcement. Recently, phase III clinical trials of BGM0504 injection hypoglycemic indications independently developed by Borui Pharmaceutical (Suzhou) Co., Ltd., a wholly-owned subsidiary of the company, have achieved the expected goals.
BGM0504-III-T2DM-01 is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study (registration number: CTR20244494/NCT06716203). The purpose was to evaluate the efficacy, safety, and tolerability of BGM0504 injections 5 mg and 10 mg compared with placebo to treat Chinese adult type 2 diabetes (T2DM) participants with poor blood sugar control after simple dietary exercise intervention. This study will be randomly distributed at a ratio of 1:1:1. BGM0504 injections will receive 5 mg, 10 mg and placebo, respectively, and treated with subcutaneous injections once a week. The core treatment period was 32 weeks. The main end point was a change in glycated hemoglobin (HbA1c) relative to the baseline after 32 weeks of administration, followed by a 20-week extended treatment period (where the placebo group was transferred to the 10 mg dose group). The baseline average glycated hemoglobin of the 227 enrolled participants was 8.3%, and women accounted for 41%. The overall baseline characteristics were balanced across all dose groups. The study received positive top-line results, with excellent results at the primary end point and all key secondary endpoints.
BGM0504 injection is a GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulin-promoting polypeptide) receptor dual agonist independently developed by the company. It can effectively activate the downstream pathways of both receptors, produce biological effects such as blood sugar control, weight loss, and treatment of fatty liver disease (MASLD) associated with metabolic dysfunction, showing the treatment of various metabolic diseases.