Oral anti-obesity medication developed by Ascletis (ASC30) demonstrates a substantial weight reduction of 12% in 2025, according to GLP-1R data.
Ascletis Pharma Inc., a Hong Kong-listed biopharmaceutical company (HKEX: 1672), has announced encouraging results from the Phase Ib MAD study of its oral small molecule GLP-1 receptor (GLP-1R) agonist, ASC30. The study, a randomized, double-blind, placebo-controlled trial conducted in the U.S., aimed to evaluate the safety, tolerability, various titration schemes, pharmacokinetics (PK), and preliminary efficacy of ASC30 in treating obesity.
The study involved participants with obesity (body mass index (BMI): 30-40 kg/m). The results revealed that ASC30 was safe and well tolerated, with only mild to moderate gastrointestinal adverse events reported. No serious adverse events (SAEs) or Grade 3 or higher adverse events were observed during the study.
The PK profile of ASC30 was summarized in Table 1. The data showed that 20 mg and 40 mg ASC30 demonstrated a superior oral PK profile at steady state. Higher area under the curve (AUC) positively correlated with greater body weight reduction.
Weekly titration from 2 mg to 5 mg was found to be an appropriate escalation pace for ASC30. No sign of plateau was observed at Day 28. ASC30 once-daily oral tablet demonstrated a 4.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment in MAD cohort 1. The results were more pronounced in MAD cohort 2, with a 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment.
Vomiting events occurred in MAD cohort 2, mostly during the 10 mg titration week. However, no vomiting event was reported during the 2 mg titration week in MAD cohort 2, nor was there any incidence of vomiting reported in MAD cohort 1 during the 28-day treatment and 7-day follow-up.
No elevations of liver enzymes including ALT, AST, and TBL were reported during the treatment. Furthermore, no abnormal findings were reported in laboratory tests, vital signs, ECGs, and physical exams.
The topline results from the 13-week Phase IIa study on obesity treatment with ASC30 are expected in the fourth quarter of the year. These results suggest that ASC30 could be a promising candidate for the treatment of obesity, and further studies are warranted to confirm these findings.
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