B · Normal
[Ascletis Pharmaceuticals: The US Phase II study of ASC30 in the treatment of type 2 diabetes has achieved positive top-line results] On October 29, Ascletis Pharmaceuticals announced that its US Phase II study evaluating the oral small molecule GLP-1 receptor (GLP-1R) agonist ASC30 in the treatment of type 2 diabetes has achieved positive top-line results. The Phase II study is a 13-week U.S. study designed to evaluate the efficacy, safety and tolerability of once-daily oral small molecule GLP-1R agonist ASC30 tablets in 100 subjects with diabetes. For the primary endpoint, ASC30 achieved a statistically significant and clinically meaningful reduction in HbA1c in subjects with diabetes compared to placebo (p < 0.0001). Based on the efficacy estimand, placebo-adjusted reductions in HbA1c (least squares mean) from baseline at Week 12 were 1.7%, 1.6%, and 1.7% in the 40 mg (n = 20), 60 mg (n = 29), and 80 mg (n = 28) dose groups, respectively. The average baseline glycosylated hemoglobin of the subjects was 8.3%.
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