Ascletis Advances Obesity Treatment with Phase IIa Clinical Study Enrollment Completion

Ascletis Advances in Obesity Treatment through New Clinical Trial

Ascletis Pharma Inc. has officially announced the completion of enrollment for its Phase IIa clinical study focusing on their novel once-monthly subcutaneous depot formulation of the small molecule GLP-1 receptor (GLP-1R) agonist, ASC30. This investigation targets participants who are either overweight or obese, specifically concentrating on those with at least one weight-related comorbidity. The study, now underway in the United States, involves a total of 65 participants who possess a body mass index (BMI) of 27 or greater.

Study Overview

The Phase IIa trial is designed as a randomized, double-blind, placebo-controlled, multi-center study, conducted to assess the efficacy, safety, and tolerability of ASC30. Participants' BMI ranges from a minimum of 27 kg/m² to 30 kg/m² or above, thereby categorizing them as overweight or obese. The study will span a total duration of 12 weeks, during which various dosages will be examined across three cohorts, thus establishing a fundamentally robust framework for evaluating ASC30’s clinical potential.

The formulation is noteworthy for its ultra-long-acting characteristics. Previous Phase Ib studies exhibited a significant half-life of approximately 46 days for participants with obesity, making it suitable for once-monthly administration. Given that efficacy is critical in the realm of obesity treatment, this extended half-life is a strong incentive for both patients and health care providers, offering less frequent dosing schedules.

What Sets ASC30 Apart

ASC30 is distinguished as the first and only investigational small molecule GLP-1R biased agonist, which demonstrates flexibility in administration routes. It was developed with the capability of being delivered not only via subcutaneous injection but also orally in tablet form. This unique property stands apart from many current treatments requiring regular injections.

The innovation behind ASC30 stems from Ascletis' Ultra-Long-Acting Platform (ULAP), which bypasses the limitations often experienced with other peptide drugs that depend on extending the half-life via albumin-binding mechanisms. Such conventional methods generally restrict the duration of drug efficacy due to albumin's own pharmacokinetic characteristics, which result in a half-life around 20 days.

Future Prospects

As Ascletis moves forward, the first quarter of 2026 is eagerly anticipated for topline data release, shedding light on the trial's outcomes. Ascletis' founder and CEO, Jinzi Jason Wu, emphasized the enrollment completion as a pivotal moment in the progression toward realizing an innovative solution for obesity management. His remarks indicated optimism regarding the potential ASC30 has to emerge as a viable once-monthly treatment alternative.

To mark this milestone, Ascletis will host a conference call in Mandarin on October 20, 2025, at 10:00 AM China Standard Time. This interactive session will invite further discussion and queries regarding the study's progress and anticipated data.

Conclusion

Ascletis Pharma is poised to make significant advancements in the therapy landscape for obesity, with their ASC30 product gaining traction through this Phase IIa study. The combination of scientific innovation and strategic clinical planning is set to potentially change how obesity is treated both in the U.S. and globally. The prospect of introducing a convenient, long-lasting treatment option represents a new chapter in combating this pervasive health issue.

For more detailed information or updates, interested parties can visit Ascletis' official web portal.