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Ascletis Reports Positive U.S. Phase Ib Results for ASC30, Submits Phase IIa Protocol to FDA
- Ascletis Pharma announced positive topline results from a U.S. Phase Ib study of its ASC30 oral tablet on April 22, 2025.
- The randomized, double-blind, placebo-controlled multiple ascending dose study evaluated ASC30 in obese participants.
- This four-week trial included three cohorts testing different weekly dose titration schemes.
- One titration scheme achieved 4.3% mean body weight reduction after four weeks of treatment.
- Results support a lower dose strategy and informed the planned U.S. Phase IIa study design submitted to FDA.
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Ascletis Announces Positive Topline Results of U.S. Phase Ib Multiple Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30 and Submission of 13-week Phase IIa Study Protocol to FDA
ASC30 oral once-daily tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 10 mg, 20 mg, and 40 mg doses.
Ascletis Reports Positive U.S. Phase Ib Results for ASC30, Submits Phase IIa Protocol to FDA
HONG KONG, April 23, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces today positive topline results 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 participants with obesity (body mass index (BMI): 30-40 kg/m2). The Phase Ib MAD study consisted of three cohorts, each with a different weekly titrati…
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