The trial targets individuals with a body mass index of 27.0 kg/m² or higher, aiming to confirm findings from preclinical models. In non-human primate studies, the drug demonstrated an absolute oral bioavailability of 6% to 8% at steady state, supported by the company’s proprietary Peptide Oral Transport ENhancement Technology (POTENT). Researchers observed a weight reduction of up to 13.2% from baseline in primates following seven days of once-daily dosing.
Ascletis Begins U.S. Phase I Trial for Oral Obesity Drug ASC36
Ascletis Pharma has launched a U.S. Phase I clinical trial for ASC36, an oral amylin receptor peptide agonist designed to treat obesity. Following FDA clearance, the study will evaluate the safety and pharmacodynamics of the drug in 86 participants, marking the company’s fourth peptide-focused trial initiation this year.
Company leadership expects the oral tablets to achieve efficacy at lower doses than current standards, potentially offering manufacturing advantages due to the high weight-loss-per-milligram ratio. ASC36 was developed using an artificial intelligence-assisted discovery platform, and its prolonged half-life—ranging from 116 to 167 hours in animal models—suggests the possibility of once-daily or even less frequent administration. This study is part of a broader push by Ascletis to diversify its metabolic pipeline, which includes both small molecule programs and long-acting injectable therapies.
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