Skip to main content

Ascletis Pharma Inc.

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

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

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.

Ascletis Doses First Patient in Phase III Trial of Oral GLP-1 Pill ASC30

Ascletis Doses First Patient in Phase III Trial of Oral GLP-1 Pill ASC30

Hong Kong – September 03, 2026 -- Ascletis Pharma Inc. has dosed the first participant in a global Phase III program for ASC30, an oral small molecule GLP-1 receptor agonist for chronic weight management, the Hong Kong Stock Exchange-listed biotech confirmed.

Trial enrolls 4,600 participants across three continents

The program comprises two pivotal trials, AURORA-1 and AURORA-2, spanning clinical sites in the U.S., Europe, and Canada. AURORA-1 targets participants with obesity or overweight without type 2 diabetes, while AURORA-2 enrolls those with type 2 diabetes; both trials test 20 mg, 40 mg, and 60 mg maintenance doses against placebo over 72 weeks, with the primary endpoint measuring percentage change in body weight from baseline to Week 72.