China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd. (SHE: 002317) announced positive top-line analysis results from dose expansion cohorts of two Phase II clinical studies for its Category 1 innovative polypeptide drug candidate RAY1225, targeting weight loss and blood glucose reduction. The preliminary results indicated that RAY1225 injection (3–9 mg) demonstrated positive efficacy and favorable safety profiles in Chinese adult obese/overweight participants and type 2 diabetes patients, achieving ideal results that met the expected goals.
RAY1225 Mechanism and Trial Design
RAY1225 is a long-acting glucagon-like peptide-1 (GLP-1) drug with dual activation activity of the GLP-1 receptor and glucose-dependent insulin-promoting polypeptide (GIP) receptor. The Phase II trial (REBUILDING-1) in obese/overweight patients and the Phase II trial (SHINING-1) in type 2 diabetes patients each comprised Part A (parallel study: 3 mg, 6 mg, and placebo groups) and Part B (dose escalation and expansion study: 9 mg escalation group and expansion group). Both trials met their primary endpoints, recently completed data cleaning and locking for the dose expansion cohorts, and obtained top-line analysis results.
Clinical Trial Results
RAY1225 injection demonstrated significant superiority over placebo in weight loss, blood glucose control, and improvement of cardiovascular, renal, and metabolic risk factors. These results highlight the potential of RAY1225 as a promising treatment option for obesity and type 2 diabetes.-Fineline Info & Tech
