Chinese pharmaceutical company Ascletis Pharma Inc (HKEX:1672) on Wednesday reported positive topline results from its US Phase II study evaluating ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist, for the treatment of type 2 diabetes mellitus (T2D).

The 13-week US study is evaluating the efficacy, safety and tolerability of oral small molecule GLP-1R agonist ASC30, a once-daily tablet, in 100 participants with diabetes. The primary endpoint is HbA1c reduction from baseline at 12 weeks, and the secondary endpoints include body weight loss from baseline at 13 weeks.

ASC30 (40 mg, 60 mg, 80 mg) met the primary and all secondary endpoints, delivering significant HbA1C reduction and weight loss, as well as improvements in multiple cardiovascular risk factors. T2D is the second indication in development for ASC30, in addition to obesity.

According to Ascletis, ASC30 titrated weekly to maintenance doses (40 mg, 60 mg and 80 mg) demonstrated favourable safety and GI tolerability, with zero study discontinuations due to GI adverse events (AEs). The favorable GI tolerability in diabetic participants was consistent with the finding from studies in obese or overweight participants. Ascletis anticipates that GI tolerability will significantly improve in the Phase III diabetic programme when titration is slowed down to once every four weeks. There was only one study discontinuation (1/80, 1.3%, hiccup) due to any AEs. The placebo group had zero study discontinuation due to any AEs.

The Phase II study enrolled 100 participants with type 2 diabetes mellitus at multiple sites across the United States. Participants were randomly assigned in a ratio of approximately 2:3:3:2 to 40 mg, 60 mg and 80 mg ASC30 tablets and matching placebo tablets, respectively. ASC30 was titrated weekly from 1 mg to maintenance doses of 40 mg, 60 mg and 80 mg.