Ascletis Unveils Promising Results for ASC30 in Body Weight Management Study at EASD 2025

Ascletis Pharma Inc., known for its innovative approaches in biotechnology, presented its findings from the 28-day multiple ascending dose (MAD) study of their oral GLP-1 receptor (GLP-1R) agonist, ASC30, during the 61st European Association for the Study of Diabetes (EASD) Annual Meeting in Vienna, Austria, on September 16, 2025. The results have sparked excitement within the medical community due to the promising implications for obesity treatment.

Significant Findings from the Study

The randomized, double-blind, placebo-controlled Phase Ib MAD study involved participants diagnosed with obesity (BMI 30-40 kg/m²) and aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of the ASC30 oral tablet. Notably, the ASC30 tablet demonstrated a 6.5% reduction in body weight from baseline after 28 days of treatment in cohort 2, which followed a titration scheme of 2 mg, 10 mg, 20 mg, and 40 mg weekly. In cohort 1, a 4.5% weight reduction was observed following a titration scheme of 2 mg, 5 mg, 10 mg, and 20 mg.

The data indicates that both the 20 mg and 40 mg doses exhibited a superior oral PK profile at steady state, with higher drug exposure correlating positively with greater weight reduction, a significant finding in weight management pharmacotherapy.

Safety Profile and Tolerability

Safety was a paramount concern in the study, and the results indicated that ASC30 was well tolerated. The adverse events observed were mild to moderate, predominantly gastrointestinal (GI) in nature. Crucially, no vomiting occurred within the first cohort, and while some vomiting was recorded in cohort 2, it mainly coincided with the 10 mg titration week. The absence of severe adverse events (SAEs) was a notable highlight, reinforcing the drug's safety profile. Laboratory tests, vital signs, and ECGs returned normal results, adding to the drug's promising standing.

Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis, expressed enthusiasm regarding the presentation of the positive data at EASD and emphasized the company's commitment to developing differentiated solutions for obesity treatment. Plans for a Phase IIa study are in progress, and topline results are expected in the fourth quarter of this year.

Future Directions: The Promise of ASC30

ASC30's unique properties as an investigational GLP-1R biased small molecule agonist allow for both oral and subcutaneous administration, which could revolutionize weight management therapies. The compound is under patent protection until 2044, leading to high expectations in its clinical development pathway.

As the world grapples with rising obesity rates, the implications of effective treatments like ASC30 are profound. The ongoing research at Ascletis underlines a significant shift towards the availability of innovative therapies targeting metabolic diseases.

Conclusion

The outcomes of the ASC30 study mark a notable advancement in obesity management and showcase Ascletis Pharma's capabilities in drug development. With further studies on the horizon, the medical and scientific communities are keenly awaiting additional findings that could potentially transform the therapeutic landscape for individuals battling obesity. To learn more about Ascletis and its offerings, interested parties can visit their official website.