Ascletis' ASC30 shows strong weight loss, improved tolerability in phase II study

Ascletis Pharma Inc. announced positive topline results for its oral GLP-1 receptor agonist, ASC30, from a 13-week U.S. Phase II study involving 125 participants with obesity or overweight. The study demonstrated a placebo-adjusted mean weight loss of 7.7% at the 60 mg dose level. All three tested doses (20 mg, 40 mg, 60 mg) met the primary endpoint with statistically significant weight reductions (p values <0.0001 vs placebo).

The study highlighted ASC30's improved gastrointestinal tolerability, with a vomiting rate approximately half that observed with orforglipron titrated weekly. All GI adverse events were mild or moderate, and there were no severe or drug-related serious adverse events. Total treatment discontinuation due to adverse events was low at 4.8%, with no hepatic safety signals or elevations in ALT, AST, or TBL.

Ascletis plans to submit these data to the U.S. Food and Drug Administration (FDA) and request an End-of-Phase II meeting in the first quarter of 2026.