Ascletis ASC30 GLP-1R Data 2025: Oral Obesity Drug Cuts Weight Twelve Per Cent

HONG KONG, Sept. 17, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that results from cohorts 1 and 2 of 28-day multiple ascending dose (MAD) study of its oral small molecule GLP-1 receptor (GLP-1R) agonist ASC30 (NCT06680440) were presented in the short oral discussion session event A at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting in Vienna, Austria on September 16, 2025.

The Phase Ib MAD study is a randomized, double-blind, placebo-controlled study, conducted in the U.S., to evaluate safety and tolerability, various titration schemes, pharmacokinetics (PK) and preliminary efficacy of ASC30 once-daily oral tablet in participants with obesity (body mass index (BMI): 30-40 kg/m²).

ASC30 once-daily oral tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment in MAD cohort 2 (weekly titrations of 2 mg, 10 mg, 20 mg, and 40 mg). ASC30 once-daily oral tablet also demonstrated a 4.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment in MAD cohort 1 (weekly titrations of 2 mg, 5 mg, 10 mg, and 20 mg). No sign of plateau was observed at Day 29.

20 mg and 40 mg ASC30 demonstrated superior oral PK profile at steady state. Higher area under the curve (AUC) positively correlated with greater body weight reduction. Table 1 summarizes the PK profile of ASC30.

Table 1. PK profile of ASC30

Notes: PK: pharmacokinetics; MAD: multiple ascending dose; T_max: time to maximum concentration, shown as median (range); C_max: maximum concentration, shown as mean±standard deviation; AUC_0-24h: area under the curve over 0-24 hours, shown as mean±standard deviation; T_1/2: half-life, shown as mean±standard deviation.

ASC30 is safe and well tolerated with only mild to moderate gastrointestinal (GI) adverse events (AEs). During 28-day treatment and 7-day follow up, MAD cohort 1 (2 mg, 5 mg, 10 mg, and 20 mg) had zero incidence of vomiting. Although vomiting events occurred in MAD cohort 2 (2 mg, 10 mg, 20 mg, and 40 mg), most of these vomiting events occurred during 10 mg titration week and no vomiting event was reported during 2 mg titration week. Taken together, the data suggest that weekly titration from 2 mg to 5 mg represents an appropriate escalation pace and provided key evidence to inform the titration schemes for the Phase IIa study design.

No serious adverse events (SAEs) were reported. There were no Grade 3 or higher AEs observed. There were no elevations of liver enzymes including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBL) during the treatment. There were no abnormal findings in laboratory tests, vital signs, ECGs (electrocardiograms, including QTc intervals), and physical exams.

Detailed data presented at the 61st EASD Annual Meeting can be found at Ascletis' website (link).

"We're very excited that we presented in an oral session the clinical data of ASC30 oral tablet at this year's EASD Annual Meeting," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. "ASC30 oral tablet has shown promising efficacy and safety data, which once again demonstrated our strong R&D capabilities to develop more differentiated options for the treatment of obesity. We're looking forward to reporting topline results from ASC30 oral tablet 13-week Phase IIa study in the fourth quarter this year."

To learn more about Ascletis, please visit www.ascletis.com.