Chinese pharmaceutical company Ascletis Pharma Inc (HKEX:1672) has announced that results from cohorts 1 and 2 of 28-day multiple ascending dose (MAD) study of its oral small molecule GLP-1 receptor (GLP-1R) agonist ASC30 were presented in the short oral discussion session event A at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting in Vienna, Austria on 16 September 2025.

The Phase Ib MAD study is a randomised, double-blind, placebo-controlled study, conducted in the USA, to evaluate safety and tolerability, various titration schemes, pharmacokinetics (PK) and preliminary efficacy of ASC30 once-daily oral tablet in participants with obesity (body mass index (BMI): 30-40 kg/m2).

According to the company, ASC30 once-daily oral tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment in MAD cohort 2 (weekly titrations of 2 mg, 10 mg, 20 mg, and 40 mg). ASC30 once-daily oral tablet also demonstrated a 4.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment in MAD cohort 1 (weekly titrations of 2 mg, 5 mg, 10 mg, and 20 mg). No sign of plateau was observed at Day 29.

The 20 mg and 40 mg doses of ASC30 demonstrated superior oral PK profile at steady state. Higher area under the curve (AUC) positively correlated with greater body weight reduction.

No serious adverse events (SAEs) were reported. There were no Grade 3 or higher AEs observed. There were no elevations of liver enzymes including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBL) during the treatment. There were no abnormal findings in laboratory tests, vital signs, ECGs (electrocardiograms, including QTc intervals), and physical exams.

"We're very excited that we presented in an oral session the clinical data of ASC30 oral tablet at this year's EASD Annual Meeting," said Jinzi Jason Wu, Ph.D., Ascletis founder, chairman and CEO. "ASC30 oral tablet has shown promising efficacy and safety data, which once again demonstrated our strong R&D capabilities to develop more differentiated options for the treatment of obesity. We're looking forward to reporting topline results from ASC30 oral tablet 13-week Phase IIa study in the fourth quarter this year."