Cully Pharmaceutical-B (01672) announced that ASC30 was approved by the US FDA for the 13-week phase II study in diabetic subjects

Zhitong Finance App News, Goli Pharmaceutical-B (01672) announced that it has recently obtained approval from the US Food and Drug Administration (FDA) for its new drug clinical trial (IND) for oral administration of small molecules GLP-1, ASC30, in diabetic subjects. The Phase II study was a 13-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of ASC30 in subjects with type 2 diabetes.

The primary endpoint of this phase II study was the average change in glycated hemoglobin (HbA1c) relative to baseline in the treatment group compared to the placebo group at 13 weeks. Secondary endpoints included: average change in fasting glucose relative to baseline in the treatment group compared to the placebo group by week 13; average change in body weight relative to baseline in the treatment group compared to the placebo group by week 13; and safety and tolerability. The Phase II study will enroll approximately 100 subjects with type 2 diabetes at multiple centers in the US. The subjects will be randomly assigned to the 40 mg, 60 mg, and 80 mg ASC30 tablet treatment group and the matching placebo group in a ratio of about 2:3:3:2. ASC30 will start at 1 mg and titrated weekly (titrated weekly) to target doses of 40 mg, 60 mg, and 80 mg. Enrollment of test subjects is expected to begin in the first quarter of 2026.

Geli recently completed its 13-week phase II study (NCT07002905) evaluating ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist, in the treatment of obesity. The study was conducted at multiple centers in the US, and a total of 125 obese subjects or overweight subjects with at least one weight-related complication were enrolled. At the primary end of week 13, 20 mg, 40 mg, and 60 mg ASC30 tablets once a day achieved average weight loss of 5.4%, 7.0%, and 7.7% after placebo correction, respectively. Weight loss was statistically significant, clinically significant, and dose-dependent. No weight loss platform period was observed. The incidence of vomiting with weekly titration up to the target dose of aC30 is approximately half that observed in published weekly titrations of Orforglipron. Gastrointestinal tolerability of weekly titrated aC30 is comparable to the published results of titrated every four weeks (titrated every four weeks) of orforglipron in the phase III ATTAIN-1 study. In the phase II study of ASC30 for the treatment of obesity or overweight, the overall discontinuation rate due to adverse events was 4.8%.

ASC30, independently developed by Goli, is the first and only small-molecule GLP-1R agonist under clinical research that can be taken orally once a day or subcutaneously once a month to once a quarter to treat obesity, diabetes, and other metabolic diseases.

“As we continue to accumulate research data related to ASC30, the approval of the IND for this phase II study for diabetes treatment is an important milestone for Geli,” said Dr. Wu Jinzi, founder, chairman of the board and CEO of Geli. “Furthermore, the FDA's approval of our IND application has broadened the path for ASC30 to enter the huge diabetes treatment market for clinical development.”