ASC30, an investigational glucagon-like 1-peptide receptor agonist, demonstrates mean weight reductions from baseline of 4.3% and 6.3% for 2 separate cohorts.
ASC30, an investigational oral, once daily tablet for patients with obesity, showed mean weight reductions from baseline of 4.3% and 6.3% for 2 separate multiple ascending dose (MAD) cohorts. The results were from 2 cohorts in a randomized, double-blinded, placebo-controlled phase Ib study (NCT06680440).
ASC30 is an investigational glucagon-like peptide-1 (GLP-1) receptor agonist. | Image Credit: Story Images | stock.adobe.com
"We are excited that these interim results from our Phase Ib MAD study demonstrated potential best-in-class characteristics to treat patients with obesity," Jinzi Jason Wu, PhD, founder, chairman, and CEO of Ascletis, said in a news release.1 "As a small molecule, ASC30 has the potential to offer both once-daily oral and once-monthly subcutaneous injection dosing options for patients, if approved."
ASC30 is an investigational glucagon-like peptide-1 (GLP-1) receptor agonist with unique and differentiated properties that uses the small molecule for both oral and subcutaneous formulations. The trial was a phase 1 study that evaluated the safety, tolerability, and pharmacokinetics of the tablet formulation in patients with obesity. Patients were non-smokers, aged 18 to 65 years, and did not have any clinically significant active or chronic diseases, diabetes, autoimmune disease, or acute or chronic pancreatitis.1,2
Trial Name: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity
ClinicalTrials.gov ID: NCT06680440
Sponsor: Ascletis Pharma (China) Co Limited
Completion Date (Estimated): February 2025
Investigators included 6 single ascending dose (SAD) cohorts and 3 MAD cohorts. The primary end points included incidence of adverse events (AEs) and serious AEs at 8 for the SAD cohort and 28 days for the MAD cohort. Secondary outcomes included cmax of the drug at 8 (SAD) and 28 days (MAD) and change from baseline body weight at 28 days (MAD).2
Each MAD cohort included 8 individuals on the study drug and 2 on matching placebo. Cohort 1 included 2 mg, 5 mg, 10 mg, and 20 mg dosages, with each dose level being received in a sequential manner. The average daily dose over 28 days was 9.25 mg. For cohort 2, investigators included 2 mg, 10 mg, 20 mg, and 40 mg, with the average daily dose being 18 mg. Investigators found that the drug was generally well tolerated in MAD cohorts 1 and 2, with a favorable safety profile and no SAEs. All gastrointestinal-related AEs were mild or moderate, and titration improved tolerability. In cohort 1, there were no incidents of vomiting, and there were no significant changes in liver enzymes observed.1
In January 2025, the company announced results from the SAD study, which consisted of 2 mg, 5 mg, 10 mg, 20 mg, and 40 mg dosages for 40 patients with obesity under fasting conditions Investigators found that the investigational table demonstrated superior pharmacokinetic prosperities to other small-molecule oral GLP-1 receptor agonists in development, with the new release from the company stating, “ASC30 oral tablet has the potential to be a best-in-class small-molecule GLP-1R agonist to treat obesity.”3
The safety profile was also well tolerated, with AEs being mild to moderate in severity. Most AEs were also gastrointestinal.3
READ MORE: Obesity Management Resource Center
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