#USA #None #GLP-1 #Ascletis #ASC30

Introduction

Ascletis Pharma has unveiled promising data from its recent Phase II clinical trial for ASC30, a novel oral small molecule GLP-1 receptor agonist specifically designed to combat obesity. Conducted in the United States, the trial tested the efficacy and safety of ASC30 in 125 participants, all of whom were categorized as overweight or obese with at least one related health condition. The results, released on December 8, 2025, reveal remarkable findings that could enhance the options available for weight management.

Study Overview

The trial spanned 13 weeks and investigated three dosage levels of ASC30: 20 mg, 40 mg, and 60 mg, with all participants randomly assigned to receive either the treatment or a placebo. The primary objective was to compare the mean percentage change in body weight from the baseline after 13 weeks.

Results

The data shows that ASC30 facilitated significant weight loss, with the 60 mg dose resulting in an impressive placebo-adjusted mean weight reduction of 7.7%. Across all dosage groups, 80% of participants taking the highest dose lost at least 5% of their body weight, compared to just 4.2% in the placebo group. Furthermore, 45% of those on the 60 mg dosage achieved a weight loss of at least 7%. These outcomes highlight not just the efficacy of ASC30, but also its potential to surpass existing obesity treatments.

In tandem with weight loss, ASC30 exhibited favorable effects on cardiovascular risk markers, including substantial reductions in total cholesterol, LDL cholesterol, triglycerides, and blood pressure across all doses. Such comprehensive benefits establish ASC30 as a potential leader in obesity management therapies.

Gastrointestinal Tolerability

A standout aspect of the ASC30 trial results is its gastrointestinal tolerability. The study reported a vomiting rate for ASC30 that was approximately half of the rate observed in the comparison medication, orforglipron. Adverse gastrointestinal events were largely mild to moderate in severity, with no severe cases reported. Discontinuation of treatment due to adverse events was minimal, at only 4.8%, demonstrating a strong safety profile.

Future Directions

Ascletis plans to engage with the U.S. Food and Drug Administration (FDA) regarding these encouraging findings and has indicated intentions to request an End-of-Phase II meeting early in 2026. This will be critical in determining the road ahead for ASC30’s further development and potential market introduction.

Conclusion

Overall, the Phase II trial results for ASC30 provide a strong indication of its efficacy and safety in weight management. With its unique profile, Ascletis is poised to make significant contributions to obesity treatments. This groundbreaking research not only emphasizes the innovative potential of ASC30 but also marks a hopeful progress in the global fight against obesity as a chronic condition. As additional Phase III studies commence, further insights will reveal the full capabilities and applications of this exciting development in metabolic health.