Hong Kong, China, October 29, 2026
Ascletis Pharma Inc. has announced positive topline results from its U.S. Phase 2 clinical trial evaluating ASC30, an investigational once-daily oral small-molecule GLP-1 receptor (GLP-1R) agonist, in adults with type 2 diabetes. The study demonstrated a statistically significant and clinically meaningful placebo-adjusted reduction in HbA1c of up to 1.7% at Week 12, meeting its primary endpoint. The company also reported significant body-weight reductions of up to 4.4% compared with placebo at Week 13, alongside improvements in several cardiovascular risk factors. Announced on October 29, 2026, the findings strengthen the clinical development prospects of ASC30 as a potential oral treatment option for people living with type 2 diabetes. The results are particularly relevant because oral GLP-1 therapies could offer an alternative administration option for patients seeking convenient long-term metabolic disease management. ASC30 is being developed as a once-daily oral tablet, with the aim of combining glucose control, weight reduction and favourable tolerability in a single investigational treatment.
ASC30 Achieves Up to 1.7% HbA1c Reduction in Phase 2 Trial
The U.S. Phase 2 study was a 13-week, randomised, double-blind, placebo-controlled, multicentre clinical trial involving 100 adults with type 2 diabetes. Participants received once-daily ASC30 tablets at maintenance doses of 40 mg, 60 mg or 80 mg, or matching placebo. The primary endpoint evaluated the change in glycated haemoglobin (HbA1c) from baseline at Week 12. Results showed that ASC30 achieved placebo-adjusted HbA1c reductions of 1.7%, 1.6% and 1.7% for the 40 mg, 60 mg and 80 mg treatment groups, respectively. These reductions were statistically significant compared with placebo, with a p-value of less than 0.0001. Participants had an average baseline HbA1c of 8.3%, indicating that the study evaluated patients with elevated blood glucose levels requiring additional metabolic control. All three tested maintenance doses met the primary endpoint, demonstrating consistent glucose-lowering activity across the evaluated dose groups. The findings provide encouraging evidence for the potential of oral GLP-1 receptor activation in managing type 2 diabetes. The observed HbA1c reductions represent an important clinical milestone for Ascletis’ ASC30 development programme, although larger and longer-duration studies will be needed to establish its long-term efficacy and safety.
Oral ASC30 Demonstrates Weight Loss and Favourable Tolerability
In addition to glucose control, ASC30 demonstrated statistically significant improvements in body weight, a key secondary endpoint assessed at Week 13. The treatment groups achieved placebo-adjusted weight reductions of 4.4%, 3.8% and 4.0% for the 40 mg, 60 mg and 80 mg doses, respectively. The company also reported that weight reduction had not reached a plateau by the end of the study period. The average baseline body weight among participants was 93.7 kg. Another important finding involved the treatment’s safety and tolerability profile. Despite weekly dose titration to the maintenance levels, no participants discontinued treatment because of gastrointestinal adverse events. Only one participant discontinued ASC30 because of an adverse event, which was hiccups. The reported drug-related adverse events were mild or moderate, with no drug-related serious adverse events observed. Furthermore, Ascletis reported no hepatic safety signals during the treatment period, with no observed elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin. These findings provide encouraging early evidence regarding the investigational medicine’s tolerability. However, the relatively short 13-week study duration means that its longer-term safety profile requires further evaluation.
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Ascletis Advances ASC30 Across Diabetes and Obesity Programmes
The positive Phase 2 diabetes findings complement the ongoing global clinical development of ASC30 for chronic weight management. Ascletis is advancing the candidate through two pivotal Phase 3 clinical trials, AURORA-1 and AURORA-2, which are being conducted in the United States, Europe and Canada. Together, these studies are expected to enrol approximately 4,600 adults with obesity or overweight, including participants with and without type 2 diabetes. The company expects topline Phase 3 obesity results in the third quarter of 2028, followed by a planned U.S. New Drug Application submission by the end of 2028 and a European Marketing Authorisation Application submission in early 2029. ASC30 was discovered and developed internally by Ascletis using its proprietary drug discovery capabilities. The company is also developing additional oral metabolic therapies and combination candidates targeting GLP-1, GIP and amylin-related pathways. Jinzi Jason Wu, Ph.D., Founder, Chairman and Chief Executive Officer of Ascletis, highlighted the significance of the Phase 2 findings and the potential of ASC30 as an oral treatment for metabolic diseases. The latest results strengthen Ascletis’ clinical development strategy in type 2 diabetes and obesity, while further clinical evaluation will determine whether ASC30 can become an approved oral GLP-1 treatment option.
Source: Ascletis Pharma press release
