Ascletis oral GLP-1 ASC30 cuts HbA1c 1.7% in Phase 2 diabetes trial

Ascletis Pharma said on October 28, 2026, that its experimental once-daily oral GLP-1 pill ASC30 lowered HbA1c by a placebo-adjusted 1.7% at the 40 mg and 80 mg doses and 1.6% at 60 mg after 12 weeks in a U.S. Phase 2 trial of 100 people with type 2 diabetes. The company said the study met its primary endpoint and all secondary endpoints ^[1].

The trial (NCT07321678) was a 13-week randomized, double-blind, placebo-controlled, multicenter study. Participants had type 2 diabetes with HbA1c between 7.0% and 10.5% at entry; the average was 8.3%. Average body weight at baseline was 93.7 kg. Participants were assigned in a ratio of about 2:3:3:2 to 40 mg (n=20), 60 mg (n=29), 80 mg (n=28) or placebo, and ASC30 was titrated weekly from 1 mg up to the maintenance dose ^[1].

At 12 weeks, placebo-adjusted HbA1c reductions were 1.7%, 1.6% and 1.7% for 40 mg, 60 mg and 80 mg, reported as least-squares means using what the company called the efficacy estimand, with p<0.0001 ^[1]. At 13 weeks, placebo-adjusted body weight reduction was 4.4%, 3.8% and 4.0% for the same doses, with p values from 0.001 to 0.003, and the company said no plateau was observed ^[1]. Ascletis also said the drug produced improvements in multiple cardiovascular risk factors but did not give numbers for those measures in the announcement ^[1].

On safety, the company reported zero study discontinuations due to gastrointestinal side effects. There was one discontinuation for any adverse event, in the 80 mg group (1 of 80 participants, 1.3%), attributed to hiccup; the placebo group had none. All drug-related adverse events were grade 1 (mild) or grade 2 (moderate), and there were no drug-related serious adverse events, according to the company ^[1]. Ascletis said no liver safety signal appeared, with no elevations in ALT, AST or total bilirubin during treatment ^[1]. The company added that it expects gastrointestinal tolerability to improve significantly in a Phase 3 diabetes program if titration is slowed to once every four weeks, compared with the weekly titration used here ^[1].

Several things were not disclosed. The announcement is a company topline release, not a peer-reviewed publication, and it does not give the absolute HbA1c reduction in each drug arm or in the placebo arm, only the differences between them. Whether participants were also taking other diabetes medicines such as metformin has not been reported. No head-to-head data against any approved GLP-1 drug has been reported, so how ASC30 compares with semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound) or orforglipron (Foundayo) is not yet known. The results describe group averages in a 100-person trial.

Why it matters for patients

Every GLP-1 medicine approved in the U.S. today is either an injection or, in the case of oral semaglutide, a tablet taken on strict timing rules; ASC30 is being developed as a once-daily tablet with no such instructions described in the announcement ^[1]. A pill that controls blood sugar with fewer stomach side effects would matter for people who dislike injections or who stop treatment because of nausea and similar complaints. In this trial, nobody dropped out for gastrointestinal reasons, though the trial was small and the drug was titrated upward quickly at weekly intervals ^[1].

ASC30 is investigational and not approved for any use. Diabetes is the second condition Ascletis is studying, after obesity ^[1]. The company said ASC30 has the potential to become the second oral small-molecule GLP-1 receptor agonist available in the U.S. and Europe if it is approved; it did not name the product that it expects to be first ^[1].

What happens next

Ascletis said its global Phase 3 program for obesity, with two trials called AURORA-1 (NCT07743463) and AURORA-2 (NCT07743450) in the U.S., Europe and Canada, is enrolling about 4,600 participants with obesity or overweight. Topline data from that program are expected in the third quarter of 2028, with a U.S. Food and Drug Administration new drug application for obesity expected by the end of 2028 and a European Medicines Agency application expected in early 2029 ^[1]. A start date or design for a Phase 3 trial in diabetes has not been disclosed.