ASCLETIS-B (01672) announced positive topline results from its 13-week Phase II study (NCT07002905) evaluating the oral small-molecule GLP-1 receptor (GLP-1R) agonist ASC30 for obesity treatment. Conducted across multiple U.S. centers, the study enrolled 125 obese or overweight subjects with at least one weight-related comorbidity.

Three doses of ASC30 oral tablets (20 mg, 40 mg, and 60 mg) were assessed. At Week 13, all doses met the primary endpoint, demonstrating statistically significant (p < 0.0001 vs. placebo) and clinically meaningful weight reduction. The 60 mg dose showed a placebo-adjusted mean weight loss of up to 7.7%. Weight loss was dose-dependent, with 20 mg, 40 mg, and 60 mg achieving 5.4%, 7.0%, and 7.7% reductions, respectively, with no plateau observed.

Baseline mean weight and BMI were 107.3 kg and 38.6 kg/m². Notably, 80.0% of subjects on 60 mg ASC30 achieved ≥5% weight loss (vs. 4.2% placebo), while 45.0% reached ≥7% (vs. 4.2% placebo). ASC30 also met secondary and exploratory endpoints, improving cardiovascular risk markers (e.g., total cholesterol, LDL-C, triglycerides, blood pressure).

Pharmacokinetics showed dose-proportional drug exposure. ASC30’s weekly titration resulted in vomiting rates approximately half those reported for orforglipron, with gastrointestinal (GI) tolerability comparable to orforglipron’s Phase III ATTAIN-1 study (titrated every four weeks). All GI adverse events (AEs) were mild-to-moderate (Grade 1–2), mostly during titration, with no severe (Grade ≥3) GI AEs or drug-related serious AEs. The overall discontinuation rate due to AEs was 4.8% (7.3% for 20 mg, 7.5% for 40 mg, 0% for 60 mg and placebo), driven solely by GI events (nausea, vomiting, constipation). No liver safety signals or elevated ALT/AST/bilirubin were observed.

Dr. Jinzi Wu, Founder, Chairman, and CEO of ASCLETIS, stated, “These Phase II results highlight ASC30’s best-in-class potential for weight loss and GI tolerability. We anticipate further tolerability improvements with four-week titration in Phase III and plan to submit these data to the FDA for an End-of-Phase II meeting in Q1 2026.”