After two weeks of treatment, GZR18 tablets resulted in an average weight reduction of up to 4.16%, with continued weight loss observed even after discontinuation. The pharmacokinetic profile supports a once-daily oral dosing regimen for GZR18 tablets.
The safety and tolerability of GZR18 tablets align with the known safety characteristics of GLP-1 receptor agonists, with no unexpected safety signals during the study. BEIJING , Nov. 12, 2024 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) 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 .
Statement: 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. Participants treated .