Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based pharmaceutical company, has announced positive top-line results from Part A of a Phase II clinical study for its Category 1 innovative polypeptide drug candidate, RAY1225. The drug demonstrated significant superiority over placebo in achieving weight loss targets and alleviating multiple cardiovascular and metabolic risk factors.
RAY1225’s Mechanism and Clinical Study 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 study involved two dosage groups of RAY1225: the 3mg group, which started at 1mg and titrated to the target dose by the 8th week for a total of 30mg over 16 weeks, and the 6mg group, which started at 1mg and titrated to the target dose by the 12th week for a total of 50mg over 12 weeks. Both groups showed a dose-dependent decrease in body weight, with the least squares mean of relative weight changes being -10.06% and -12.97%, respectively, compared to -3.62% in the placebo group. Both dosage groups significantly outperformed the placebo group in terms of weight loss (P<0.001).
Weight Loss Compliance and Additional Benefits
In terms of weight loss compliance, 73.2% and 95.1% of participants in the 3mg and 6mg groups, respectively, achieved a percentage change in weight from baseline of ≥ 5%. The proportion of participants whose weight decreased by ≥ 10% from baseline was 51.2% and 75.6%, respectively. Moreover, RAY1225 showed significant comprehensive advantages in improving cardiovascular and metabolic related indicators such as blood pressure, triglycerides, total cholesterol, low-density lipoprotein cholesterol, blood uric acid, liver enzymes, liver fat content, fasting blood glucose, and glycated hemoglobin HbA1c, compared to the placebo group.-Fineline Info & Tech
