Hong Kong, September 8, 2026
Ascletis Pharma Inc. has announced the initiation of a U.S. Phase 1 clinical trial evaluating ASC36 oral tablets, an investigational oral amylin receptor peptide agonist being developed for the treatment of obesity. The milestone follows recent U.S. FDA Investigational New Drug (IND) clearance and represents the fourth Phase 1 peptide study initiated by Ascletis in 2026. The clinical program will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASC36 in adults with obesity or overweight, while also advancing the company’s proprietary technology for the oral delivery of peptide medicines.
Phase 1 Trial to Evaluate ASC36 in 86 Participants
The Phase 1 study is designed to enroll 86 participants with obesity, defined as a body mass index (BMI) of at least 30.0 kg/m², or overweight, defined as a BMI of at least 27.0 kg/m². Participants will receive single and multiple ascending oral doses of ASC36, allowing investigators to characterize the candidate’s safety and tolerability while examining its pharmacokinetic and pharmacodynamic profiles. The initiation of the U.S. study marks an important transition for ASC36 from preclinical development into human clinical evaluation. ASC36 is an amylin receptor peptide agonist discovered and developed internally by Ascletis using its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) platform. The company subsequently developed the oral tablet formulation using its Peptide Oral Transport ENhancement Technology (POTENT), a technology intended to improve the delivery of peptide medicines through the gastrointestinal tract. The company believes the approach could help address one of the major challenges associated with developing convenient oral peptide therapies.
Preclinical Data Support Oral Peptide Development
Before entering clinical testing, ASC36 demonstrated encouraging pharmacokinetic and weight-loss findings in non-human primate (NHP) studies. At steady state, 10 mg once-daily oral ASC36 achieved approximately 8% absolute oral bioavailability and an elimination half-life of 116 hours, while a 25 mg dose achieved approximately 6% bioavailability and a half-life of 167 hours. According to Ascletis, these prolonged half-life findings could support once-daily or potentially less frequent oral dosing. The candidate also produced significant weight-loss effects in preclinical models. In NHPs, once-daily administration for seven days reduced mean body weight by up to 13.2% from baseline and significantly reduced food intake. In a separate diet-induced obese rat study, subcutaneous ASC36 produced approximately 32% greater relative body-weight reduction than eloralintide and approximately 91% greater reduction than petrelintide after seven days of treatment. These findings are preclinical and will need to be validated through human clinical studies.
Advertisement
ASC36 Strengthens Ascletis Obesity Pipeline
The ASC36 program forms part of Ascletis’ broader strategy to develop differentiated therapies for obesity and metabolic diseases. The company is advancing multiple peptide and small-molecule programs, including oral and injectable candidates targeting pathways such as GLP-1, GIP and amylin receptors. Ascletis said ASC36’s potential oral bioavailability and weight-loss activity could allow the candidate to be developed at a lower dose than some existing oral peptide approaches, potentially offering manufacturing scalability advantages. The initiation of human testing is therefore an important clinical development milestone, but ASC36 remains an investigational therapy. The ongoing Phase 1 study will provide the first clinical assessment of its safety, tolerability, pharmacokinetics and pharmacodynamics in people with obesity or overweight. Future clinical development will be required to determine whether the preclinical weight-loss findings translate into meaningful and durable benefits in patients.
Source: Ascletis Pharma press release
