Ascletis announces positive Phase 2 results for ASC30, a small-molecule GLP-1 agonist, showing significant weight loss with once-monthly subcutaneous dosing in obesity.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Ascletis Pharma Inc. has reported positive topline results from a U.S. Phase II clinical trial evaluating the subcutaneous (SQ) depot formulation of its investigational GLP-1 receptor agonist ASC30 for the treatment of obesity.
The 24-week randomized, double-blind, placebo-controlled study (NCT06679959) enrolled 65 adults with obesity or overweight with at least one weight-related comorbidity.
The trial met its primary endpoint, with patients receiving three once-monthly doses of ASC30 SQ depot formulation A1 achieving statistically significant and clinically meaningful weight loss. At week 12, participants receiving ASC30 A1 experienced a placebo-adjusted mean weight reduction of 6.3%, which further increased to 7.5% at week 16 after the third monthly dose.
ASC30 A1 was administered as three 400 mg injections at day 1, week 4, and week 8. The treatment produced progressive placebo-adjusted weight reductions of 2.7% at week 4, 5.5% at week 8, 6.3% at week 12, and 7.5% at week 16. These results suggest the therapy could potentially be administered once monthly and possibly every two months without requiring the weekly dose escalation typically used with GLP-1 therapies.
The study also evaluated ASC30 A1 as a potential maintenance therapy following the final dose. During the 16-week maintenance period, the drug maintained therapeutic exposure and sustained weight reduction.
Placebo-adjusted weight loss reached 6.4% at week 20, three months after the final dose, and remained at 5.8% at week 24. These findings suggest the formulation may support once-quarterly dosing for maintenance therapy in obesity.
Both ASC30 depot formulations (A1 and A2) were generally safe and well tolerated. No participants discontinued treatment due to adverse events. Reported adverse events were mild to moderate in severity, including injection site reactions. Gastrointestinal events were mild (grade 1) with no moderate or severe cases reported. No hepatic safety signals or clinically significant abnormalities were observed in laboratory tests, ECGs, vital signs, or physical examinations.
According to Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis, ASC30 is the first incretin therapy to demonstrate weight-loss activity across multiple dosing approaches, including once-daily oral dosing, once-monthly subcutaneous dosing for treatment, and once-quarterly dosing for maintenance in Phase II studies.
ASC30 is an investigational GLP-1 receptor biased small-molecule agonist discovered and developed in-house by Ascletis. The compound is designed to support both oral tablet and subcutaneous depot formulations for chronic weight management. The therapy is currently protected by global patents through 2044.
Reference
Ascletis Announces Positive Topline Results from U.S. Phase II, 24-Week Study for Its Ultra-Long-Acting Subcutaneous Depot Formulations of Small Molecule GLP-1R Agonist ASC30 for Obesity, 10 March 2026, https://www.ascletis.com/news_detail/200/id/1352.html
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants with Obesity, ClinicalTrials.gov ID NCT06679959, https://clinicaltrials.gov/study/NCT06679959?cond=ASC30&rank=3
About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.