Bi-weekly GLP-1 Agonist GZR18 Achieves 17.29% Weight Loss in 30 Weeks in Phase IIb Trial

Gan & Lee Pharmaceuticals has announced positive outcomes from a phase IIb clinical trial of their long-acting GLP-1 receptor agonist, GZR18 injection, aimed at treating obesity and overweight conditions in adults in China. This multi-center, randomized, double-blind, placebo-controlled study was conducted at 25 clinical trial centers across China and included 340 participants. These participants were either overweight with a BMI of at least 24 kg/m² and had at least one weight-related comorbidity or were obese with a BMI of at least 28 kg/m² and had poor control over their diet and exercise.

Participants in the study were randomly assigned to receive bi-weekly doses of 12 mg, 18 mg, 24 mg, or 48 mg, or a once-weekly dose of 24 mg GZR18 injection, or a placebo, for a total duration of 30 weeks. The primary aim of the trial was to evaluate the percent change in body weight from the baseline after the 30-week treatment period. Other measured outcomes included changes from baseline in average weight, waist circumference, waist-to-hip ratio, BMI, glycemic parameters, as well as the safety and tolerability of the drug.

At the end of the 30-week treatment period, participants receiving GZR18 injections demonstrated significant reductions in body weight compared to the placebo group. Specifically, the mean percent changes in body weight from baseline were -11.15% in the 12 mg bi-weekly group, -13.22% in the 18 mg bi-weekly group, -14.25% in the 24 mg bi-weekly group, -17.29% in the 48 mg bi-weekly group, and -17.78% in the once-weekly 24 mg group. In contrast, the placebo group exhibited a mean percent change of only -0.99%. The results indicated that GZR18 was significantly more effective in reducing body weight than the placebo. Moreover, there was no notable difference in the efficacy between the bi-weekly 48 mg dose and the once-weekly 24 mg dose (one-sided test, P > 0.025).

Safety and tolerability assessments showed that GZR18 injections were well-tolerated among participants. The most common adverse events reported were gastrointestinal reactions, which were generally mild to moderate in severity. These safety findings were consistent with those associated with other GLP-1 receptor agonists.

Gan & Lee Pharmaceuticals plans to release the comprehensive results of this phase IIb study later in the year and intends to publish the findings in a peer-reviewed journal. This promising development adds to Gan & Lee's portfolio, which already includes several insulin analog products and medical devices for diabetes management. The company continues to expand its presence in both domestic and international markets, with approvals from regulatory bodies such as the US FDA and the European Medicines Agency.

Looking ahead, Gan & Lee is committed to expanding its range of treatments for diabetes and other metabolic diseases. The company aims to become a leading global pharmaceutical enterprise, dedicated to the development of new chemical entities and biological drugs targeting various therapeutic areas, including cardiovascular diseases.

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