Ascletis Begins Phase II Study for ASC30, a New Diabetes Treatment

Ascletis Initiates Phase II Study for Diabetes Treatment with ASC30

In an exciting development for diabetes management, Ascletis Pharma Inc. (HKEX: 1672) has announced that the first participants have been dosed in a Phase II clinical trial for ASC30, an oral small molecule GLP-1 receptor agonist specifically aimed at treating type 2 diabetes. This 13-week study, taking place across various sites in the U.S., aims to evaluate the efficacy, safety, and tolerability of ASC30 in managing blood glucose levels and related weight issues.

Study Overview

The Phase II study, officially designated under NCT07321678, is carefully structured as a randomized, double-blind, placebo-controlled trial. Enrolling approximately 100 participants diagnosed with type 2 diabetes, the study's primary endpoint focuses on the mean change in HbA1c levels from baseline after 13 weeks of treatment. Additionally, secondary endpoints will assess fasting blood glucose levels and body weight changes, as well as the overall safety and tolerability of the treatment.

Significance of ASC30

ASC30 has previously exhibited promising results in a related Phase II study targeting obesity, showcasing significant weight reductions of up to 7.7% among participants. Notably, these findings were achieved with a lower rate of gastrointestinal side effects compared to similar treatments. This once-daily oral medication is notable not only for its efficacy but also for its ease of use, fueling hope for many patients struggling with weight management and diabetes.

The innovation of ASC30 lies in its classification as a fully biased agonist, setting it apart from other treatments currently available. Patients have expressed a clear need for effective, manageable options that can seamlessly fit into their routines, making this development particularly noteworthy.

Dr. Jinzi Jason Wu, the Founder and CEO of Ascletis, emphasized the strategic importance of this study. He stated, "Expanding ASC30's clinical development into the large diabetes treatment market is a logical next step that provides us with another chance to highlight ASC30's potential best-in-class profile as a once-daily oral treatment option for patients."

Timeline for Results

Topline data from the Phase II study is anticipated in the third quarter of 2026, offering insights into ASC30's viability as a daily treatment for type 2 diabetes. The world eagerly awaits these results to evaluate how ASC30 might change the treatment landscape for individuals with diabetes.

Conclusion

As the diabetes epidemic continues to rise globally, innovative treatments like ASC30 hold the potential to significantly alter patient care. The focus on user-friendly dosing and reducing side effects aligns with the growing demand for therapeutic options that prioritize quality of life alongside clinical efficacy. Keep an eye out for the upcoming results from this pivotal study — they could represent a monumental shift in diabetes treatment and management practices.

Ascletis Pharma's commitment to improving metabolic disease treatments is evident in its ongoing research and development efforts. For now, all eyes will be on the results from the ongoing Phase II study, which may pave the way for new standards in diabetes care.

For more about Ascletis and its therapeutic advancements, visit Ascletis Pharma's official website.