Gan & Lee Pharmaceuticals has started a U.S. Phase 1 trial of ASC36, an oral amylin receptor agonist peptide for obesity, after receiving Investigational New Drug clearance from the FDA. The study plans to enroll 86 obese or overweight subjects and will assess safety, tolerability, pharmacokinetics and pharmacodynamics through single-ascending-dose and multiple-ascending-dose designs. In preclinical studies, ASC36 tablets reduced mean body weight by as much as 13.2% in non-human primates after seven days of once-daily dosing, achieved 6% to 8% absolute oral bioavailability at steady state and showed elimination half-lives of 116 to 167 hours. Gan & Lee said the profile could support daily or less frequent dosing, while noting that clinical dose and efficacy remain to be established. ASC36 is the company’s fourth Phase 1 peptide study this year and was developed using its AISBDD discovery platform and POTENT oral peptide-delivery technology.