Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based biopharmaceutical company, has announced promising top-line results from a Phase I clinical trial for its innovative polypeptide drug candidate, RAY1225. This long-acting glucagon-like peptide-1 (GLP-1) therapy features dual activation of both the GLP-1 and glucose-dependent insulin-promoting polypeptide (GIP) receptors.
The randomized, double-blind, placebo-controlled Phase I trial, involving dosage escalation, aimed to evaluate the safety and tolerability of RAY1225 in healthy and obese individuals. Preliminary findings reveal that RAY1225 demonstrates excellent safety tolerability and favorable pharmacokinetic (PK) properties, significantly contributing to weight reduction in overweight and obese participants.
RAY1225 achieves peak levels between 16 to 72 hours following subcutaneous injection, boasting a half-life of 9 to 11 days. All subjects reported good tolerability, with some experiencing transient decreases in appetite and gastrointestinal reactions. Among the healthy cohort, a single subcutaneous injection ranging from 0.5mg to 40mg led to a dose-dependent weight loss effect, averaging a reduction of approximately 4.12% from baseline after one week. In the obese group, participants administered 9mg and 12mg doses of RAY1225 bi-weekly for six weeks exhibited significant weight reductions of 5.33% and 7.90%, respectively. Notably, the high-dose group continued to show a decline in average body weight after eight weeks, suggesting that the weight loss effects of RAY1225 may have a prolonged impact.- Flcube.com