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Ascletis Gains FDA Clearance for Once-Monthly Obesity Drug Trial

With the U.S. Food and Drug Administration granting an Investigational New Drug clearance, Ascletis Pharma is set to launch a Phase I clinical trial for ASC35. The drug, a dual peptide agonist designed for once-monthly administration, aims to challenge current weight-loss standards by offering a more convenient injection schedule.

Ascletis Gains FDA Clearance for Once-Monthly Obesity Drug Trial
Photo: Bio & News

The upcoming trial will enroll 84 participants, targeting individuals with obesity or those who are overweight with related health conditions. Researchers will conduct the study in two distinct stages: an initial single ascending dose assessment followed by a head-to-head comparison against the FDA-authorized tirzepatide. By utilizing its proprietary Self-Assembling Lipid Depot technology, Ascletis aims to achieve a controlled, slow release of the medication over a full month.

Preclinical data suggest a significant performance edge for the candidate. In non-human primate studies, ASC35 exhibited a half-life approximately six times longer than that of tirzepatide. Furthermore, tests on diet-induced obese mice indicated that the drug achieved 71% greater relative body weight reduction compared to the market-leading treatment. Company leadership anticipates that these pharmacokinetic advantages, paired with a less frequent dosing regimen, will address critical gaps in current obesity management.

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