Ascletis Begins U.S. Phase I Trial for Oral Obesity Drug ASC36

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.

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.