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, China — 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:
1. GZR18 tablet is an ivestigational drug and has not yet been approved in China.
2. 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. Participants treated with the target dose of 60 mg daily for two weeks exhibited an average weight reduction of 4.16% from baseline. Furthermore, a week after stopping 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.
About GZR18 Tablets
GZR18 tablet is 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.
Forward-looking statements
Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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