Ascletis Announces Positive Interim Results from First Two Cohorts of U.S. Phase Ib Multiple Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30

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[{"type":"text","content":"-  ASC30 oral once-daily tablet demonstrated a 6.3% mean body weight reduction from baseline after 28-day treatment in multiple ascending dose (MAD) cohort 2 (weekly titrations of 2 mg, 10 mg, 20 mg, and 40 mg).-  ASC30 oral once-daily tablet also demonstrated a 4.3% 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).-  0.1% mean body weight reduction from baseline was observed after 28-day treatment with matching placebo tablets.","length":542,"tagName":"p"},{"type":"text","content":"HONG KONG, Feb. 19, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces today positive interim results from the first two cohorts of its randomized, double-blind, placebo-controlled Phase Ib multiple ascending dose (MAD) study (NCT06680440), conducted in the U.S., of ASC30 oral once-daily tablet in patients with obesity (body mass index (BMI): 30-40 kg/m2). The Phase Ib MAD study consists of 3 cohorts, with eight patients in each cohort on ASC30 tablets and two patients in each cohort on matching placebo. Cohort 1 had four dose levels (2 mg, 5 mg, 10 mg, and 20 mg). Patients in cohort 1 received each dose level of ASC30 or placebo for seven days in a sequential manner. The average daily dose over the 28-day treatment period was 9.25 mg ASC30 for cohort 1. Cohort 2 had four dose levels (2 mg, 10 mg, 20 mg, and 40 mg). Patients in cohort 2 received each dose level of ASC30 or placebo for seven days in a sequential manner. The average daily dose over the 28-day treatment period was 18 mg ASC30 for cohort 2.","length":1078,"tagName":"p"},{"type":"text","content":"Mean body weight reductions from baselines were 4.3% and 6.3% for MAD cohorts 1 and 2, respectively, after 28-day treatment with ASC30 oral once-daily tablets. Placebo-adjusted mean body weight reductions from baselines were 4.2% and 6.2% for MAD cohorts 1 and 2, respectively.","length":277,"tagName":"p"},{"type":"text","content":"ASC30 was generally well tolerated in MAD cohorts 1 and 2, with a favorable safety profile. There were no serious adverse events (SAEs). All gastrointestinal (GI)-related adverse events (AEs) were mild (grade 1) or moderate (grade 2). Weekly titrations of ASC30 improved GI tolerability. In MAD cohort 1, t...

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