Gan & Lee Pharmaceuticals announced the positive topline results of a Phase 1 clinical trial its oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) GZR18 tablets in healthy participants in China. GZR18 tablet is an ivestigational drug and has not yet been approved in China. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications.
The Phase 1 clinical trial (CTR20240663) was a randomized, open-label, first-in-human study involving 92 participants, designed to assess the bioavailability, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GZR18 tablets in Healthy adult participants. The study also evaluated the effect of meal timing on the drug's PK, PD, safety, and tolerability. In this study, GZR18 tablets were safe and well-tolerated, with the most common adverse events being gastrointestinal reactions, consistent with the established safety profile of GLP-1 based therapies.
PK data indicated favorable absorption, supporting a once-daily oral regimen. Both single and multiple doses showed a dose-response relationship in terms of PK and PD parameters. Furthermore, a week after shopping treatment, subjects continued to lose weight 0.51%, reaching an average total reduction of 4.67% compared to baseline.
At 21 days after discontinuation, neither the participants' body weight nor BMI had returned to baseline values. GZR18 tablet are an investigational, once-daily oral GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals. It utilizes a small molecule absorption enhancer, SNAC (N-[8-(2-hydroxybenzoyl)amino]caprylate), to facilitate drug absorption in the stomach by resisting pepsin degradation, thus prolonging the drug's half-life and enhancing its bioavailability.
GZR18 tablets are currently in global Phase 1 clinical development.
