Ascletis’ Oral ASC30 Delivers Up to 1.7% HbA1c Reduction

Ascletis Pharma reported positive topline results on October 29, 2026, from its U.S. Phase II study of ASC30 in type 2 diabetes (NCT07321678). The investigational once-daily oral small-molecule GLP-1 receptor agonist reduced HbA1c and body weight versus placebo. Although the findings support further development, the short treatment period and relatively small dose groups limit conclusions about long-term efficacy and safety.

Study Design and Dosing

The randomized, double-blind, placebo-controlled, multicenter study enrolled 100 participants with type 2 diabetes and baseline HbA1c levels of 7.0% to 10.5% at U.S. sites. Participants were assigned in an approximate 2:3:3:2 ratio to ASC30 40 mg, 60 mg or 80 mg, or matching placebo.

Treatment began at 1 mg, with weekly dose escalation to the assigned maintenance dose. The primary endpoint was change in HbA1c from baseline at Week 12, while body-weight change at Week 13 was a secondary endpoint.

HbA1c Reductions Across All Three Doses

At Week 12, placebo-adjusted least-squares mean HbA1c reductions were 1.7% with 40 mg, 1.6% with 60 mg and 1.7% with 80 mg. All three comparisons were statistically significant (p<0.0001). Mean baseline HbA1c was 8.3%.

The reported efficacy populations comprised 20, 29 and 28 participants in the respective dose groups. The efficacy estimand evaluates treatment effects among eligible randomized participants while adhering to treatment.

The similar results across doses do not demonstrate a clear incremental HbA1c benefit from increasing the dose from 40 mg to 80 mg. Further analyses will be needed to establish the dose-response relationship and determine the most appropriate dose for later-stage development.

Weight Reduction and Tolerability Findings

At Week 13, placebo-adjusted least-squares mean body-weight reductions were 4.4%, 3.8% and 4.0% with the 40 mg, 60 mg and 80 mg doses, respectively (p=0.001 to 0.003). Mean baseline body weight was 93.7 kg. Ascletis reported that the study met its primary and all secondary endpoints, including improvements in multiple cardiovascular risk factors, although the announcement did not provide detailed results for those measures.

Despite weekly dose escalation, no participant discontinued treatment because of gastrointestinal adverse events. One of the 80 ASC30-treated participants discontinued because of an adverse event, hiccups, while no placebo-treated participant discontinued because of an adverse event. All drug-related adverse events were grade 1 or 2, and no drug-related serious adverse events were reported.

The company also reported no elevations in alanine aminotransferase, aspartate aminotransferase or total bilirubin during treatment. The safety profile was described as consistent with findings from its Phase II obesity study (NCT07002905).

Ascletis expects gastrointestinal tolerability to improve in the Phase III diabetes programme with titration slowed to once every four weeks. This remains a company expectation rather than an outcome demonstrated in the current study.

Obesity Programme Leads the Development Timeline

ASC30 is being developed for both obesity and type 2 diabetes. Its global Phase III obesity programme comprises AURORA-1 (NCT07743463) and AURORA-2 (NCT07743450), which are enrolling approximately 4,600 participants across the United States, Europe and Canada.

Ascletis expects topline obesity results in the third quarter of 2028, followed by a planned U.S. new drug application by the end of 2028 and a European marketing authorisation application in early 2029. These milestones relate to obesity, not the Phase III diabetes programme. The company has not provided a diabetes Phase III trial identifier, detailed design or readout timeline in the announcement.

CEO Jinzi Jason Wu said the results strengthened the company’s confidence in ASC30 as a potential best-in-class oral small-molecule GLP-1 treatment. That positioning remains a company claim, as the reported study did not establish superiority over other therapies.

Clinical Interpretation

The study provides early evidence that oral ASC30 can reduce HbA1c and body weight over 12 to 13 weeks in people with type 2 diabetes. The magnitude of the reported HbA1c reduction is notable, but the findings are based on small dose-specific populations and company-reported topline data.

The absence of gastrointestinal adverse event-related discontinuations is encouraging, although it does not mean gastrointestinal adverse events were absent. Longer studies are needed to assess durability, longer-term safety and the dose-response relationship. Without direct comparative trials, the data also cannot establish that ASC30 is superior to other GLP-1 receptor agonists.

If ASC30 successfully completes clinical development and receives FDA approval, it could enter an increasingly competitive oral obesity-treatment market alongside Novo Nordisk’s Wegovy pill (oral semaglutide) and Eli Lilly’s Foundayo (orforglipron), both of which have received FDA approval for weight management.

However, ASC30’s current Phase II diabetes results do not establish comparable weight-loss efficacy or superiority over either product. Its eventual competitive position will depend on results from longer-duration trials, its safety and tolerability profile, dosing characteristics and regulatory approval.

Reference

Exogenus Therapeutics leads a €13 million EU-funded consortium to advance a new secretome-based therapy for osteoarthritis, Exogenus Therapeutics, 29 October 2026

A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants with Type 2 Diabetes Mellitus, ClinicalTrials.gov ID NCT07321678

A Study to Evaluate the Efficacy, Safety, and Tolerability in Participants with Obesity or Overweight with Weight-Related Comorbidities, ClinicalTrials.gov ID NCT07002905