Gan & Lee Pharma Reports Positive Phase 1 Results for Oral GLP-1 Agonist GZR18, Shows 4.16% Weight Loss in 2 Weeks

Gan & Lee Pharmaceuticals has announced promising initial results from a Phase 1 clinical trial of its oral GLP-1 receptor agonist, GZR18 tablets, conducted in healthy participants in China. The study, involving 92 participants, aimed to evaluate the bioavailability, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GZR18 tablets. The trial was designed as a randomized, open-label, first-in-human study and also assessed the impact of meal timing on the drug's PK, PD, safety, and tolerability.

The results revealed that GZR18 tablets are both safe and well-tolerated, with the most common adverse events being gastrointestinal reactions. These findings are consistent with the established safety profile of GLP-1 based therapies. The PK data indicated favorable drug absorption, supporting the feasibility of a once-daily oral dosing regimen. Both single and multiple doses demonstrated a clear dose-response relationship in terms of PK and PD parameters.

Notably, after two weeks of treatment with a daily 60 mg dose, participants experienced an average weight reduction of 4.16% from baseline. Even after discontinuation of the treatment, the participants continued to lose weight, resulting in a total average weight reduction of 4.67% from baseline after an additional week. Moreover, 21 days post-treatment, the participants' body weight and BMI had not returned to the baseline values.

GZR18 tablets are an investigational, once-daily oral GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals. The formulation includes a small molecule absorption enhancer, SNAC, which facilitates drug absorption in the stomach by resisting pepsin degradation. This mechanism helps to prolong the drug’s half-life and enhance its bioavailability. Currently, GZR18 tablets are undergoing Phase 1 clinical development globally.

Gan & Lee Pharmaceuticals is known for its pioneering work in developing the first Chinese domestic insulin analog. The company now offers a range of six key insulin products, including long-acting and fast-acting insulin analogs such as Basalin® and Prandilin™, as well as mixed insulin injections like Rapilin®30. Additionally, Gan & Lee has developed two medical devices approved in China: the reusable insulin injection pen (GanleePen) and the disposable pen needle (GanleeFine®).

In the recent 2024 National Insulin-Specific Centralized Procurement in China, Gan & Lee Pharmaceuticals ranked first among all selected companies for insulin analog procurement demand. The company is also expanding its footprint internationally, with the GanleeFine® pen needle receiving FDA approval in 2020 and GMP inspection approval from the European Medicines Agency (EMA) in 2024. These milestones enhance Gan & Lee's competitiveness in both domestic and international markets.

Looking ahead, Gan & Lee Pharmaceuticals aims to achieve comprehensive coverage in diabetes treatment and aspires to become a world-class pharmaceutical company. The company continues to innovate in the development of new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.