Hong Kong – September 11, 2026 -- Ascletis Pharma Inc. (HKEX: 1672) has initiated a U.S. Phase I trial of ASC36, an oral amylin receptor peptide agonist for obesity, after securing Investigational New Drug clearance from the FDA.
Trial enrolls 86 participants to test safety and dosing
The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ASC36 across single and multiple ascending oral doses in 86 participants with obesity (BMI ≥ 30.0 kg/m2) or overweight status (BMI ≥ 27.0 kg/m2). This marks the fourth Phase I peptide study Ascletis has launched in 2026.
Preclinical data show 13.2% body weight reduction in primates
In non-human primate studies, ASC36 oral tablets achieved absolute oral bioavailability of 6% to 8% at steady state using Ascletis' proprietary POTENT delivery technology. A 10 mg once-daily dose over seven days produced 8% bioavailability and a 116-hour elimination half-life, while a 25 mg dose yielded 6% bioavailability and a 167-hour half-life. Once-daily dosing for seven days reduced mean body weight by up to 13.2% from baseline and significantly cut food intake.
Subcutaneous formulation outperforms rival amylin agonists in rat model
In a head-to-head diet-induced obese rat model, ASC36 subcutaneous injection delivered approximately 32% greater relative body weight reduction than eloralintide and 91% greater reduction than petrelintide injection after seven days of treatment.
Lower dosing could cut manufacturing costs
Ascletis expects ASC36 oral tablets to require a lower dose than a recently FDA-approved oral GLP-1R peptide agonist, based on its bioavailability and efficacy profile. The company states this weight-loss efficiency per milligram of peptide may offer scalability advantages in manufacturing.
Founder, Chairman and CEO Jinzi Jason Wu said the four Phase I peptide studies launched in 2026 validate the company's POTENT oral peptide delivery technology, positioning ASC36 alongside Ascletis' oral small molecule and long-acting injectable programs for obesity and metabolic disease treatment.