BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166), a Chinese biopharmaceutical company, has announced positive results from the Phase II clinical study (CTR20233198) for its investigational drug BGM0504. This dual agonist targets GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin stimulating polypeptide) receptors and is being studied for the treatment of overweight or obesity without diabetes.
The study, a randomized, double-blinded, placebo-controlled trial, was designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) characteristics, and efficacy of BGM0504 with multiple administrations. It enrolled 120 Chinese subjects, and preliminary results indicate that BGM0504 at doses of 5 mg, 10 mg, and 15 mg demonstrated good overall tolerability and safety after once-weekly administration for 26-30 weeks. Subjects in each dose group experienced significant improvements in key weight loss indicators, such as body weight and waist circumference, compared to the placebo group (p<0.0001). Additionally, secondary treatment evaluation indicators, including cardiovascular metabolic risk markers, insulin sensitivity-related indicators, and patient-reported outcome measures, showed improvements in all dose groups compared to baseline and were superior to the placebo group.
In the same therapeutic space, Eli Lilly & Co.’s (NYSE: LLY) Zepbound (tirzepatide) has been approved for marketing in China. Meanwhile, global pharmaceutical companies like Roche, Huadong Medicine, and Tonghua Dongbao Pharma are also developing their own GIP/GLP-1 receptor dual agonists, indicating a competitive landscape in this field.- Flcube.com
