HONG KONG – October 29, 2026 -- Ascletis Pharma (HKEX: 1672) reported that its oral small molecule GLP-1 receptor agonist ASC30 cut HbA1c by a placebo-adjusted 1.7% at the 40 mg dose, 1.6% at 60 mg and 1.7% at 80 mg in a U.S. Phase II study in type 2 diabetes. The 13-week trial (NCT07321678) met its primary endpoint and all secondary endpoints, the company said.
ASC30 delivers placebo-adjusted weight loss of up to 4.4% with no plateau
Placebo-adjusted body weight reductions at 13 weeks were 4.4% (40 mg, n=20), 3.8% (60 mg, n=29) and 4.0% (80 mg, n=28). No weight plateau was observed. Baseline average body weight was 93.7 kg. The weight results were statistically significant versus placebo (p = 0.001 to 0.003).
HbA1c reductions were significant versus placebo (p < 0.0001) on the efficacy estimand, which evaluates randomized eligible participants who adhered to treatment. Participants began with an average HbA1c of 8.3%. Ascletis also reported improvements in multiple cardiovascular risk factors, without giving figures.
No participant discontinues for GI adverse events despite weekly titration
ASC30 was titrated weekly from 1 mg to the maintenance doses. Despite this fast schedule, no participant stopped the study because of gastrointestinal adverse events. Only one participant discontinued for any adverse event (1/80, 1.3%), citing hiccups. The placebo group had no discontinuations.
Ascletis expects GI tolerability to improve significantly in Phase III diabetes studies, where titration will slow to once every four weeks. All drug-related adverse events were grade 1 (mild) or grade 2 (moderate), and there were no drug-related serious adverse events.
Liver safety data show no ALT, AST or bilirubin elevations
No hepatic safety signal emerged. Ascletis recorded no elevations of alanine transaminase, aspartate aminotransferase or total bilirubin during treatment. The overall profile matched that of a separate Phase II study (NCT07002905) in people with obesity or overweight.
Study enrolled 100 participants with baseline HbA1c of 7.0% to 10.5%
The randomized, double-blind, placebo-controlled, multi-center trial enrolled 100 participants across U.S. sites. They were assigned in an approximate 2:3:3:2 ratio to ASC30 40 mg, 60 mg, 80 mg or matching placebo tablets. The drug is a once-daily tablet.
Founder, Chairman and CEO Jinzi Jason Wu said the data show ASC30 could be a "best-in-class" oral small molecule GLP-1 for diabetes as well as for obesity.
Obesity Phase III program targets 4,600 participants and 2028 filings
Diabetes is ASC30's second indication after obesity. The global Phase III obesity program comprises two pivotal trials, AURORA-1 (NCT07743463) and AURORA-2 (NCT07743450), in the U.S., Europe and Canada. It is enrolling approximately 4,600 participants.
Topline Phase III data are expected in the third quarter of 2028. Ascletis plans an FDA New Drug Application for obesity by the end of 2028 and an EMA Marketing Authorisation Application in early 2029. If approved, ASC30 could become the second oral small molecule GLP-1 receptor agonist available in the U.S. and Europe.