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THE BAJA POST
NEWSROOM
SOURCE: PR NEWSMEDIA
Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced the results of the Phase 1b/2a clinical study of the Company’s independently developed glucagon-like peptide-1 (GLP-1) receptor agonist, GZR18 Injection, in an obese/overweight population in China, along with the results of two other innovative insulins’ preclinical studies in poster presentations at the American Diabetes Association’s（ADA’s）84th Scientific Sessions.
This randomized, double-blind, placebo-controlled, dose-escalation Phase 1b/2a clinical study evaluated the safety, tolerability, pharmacokinetics and efficacy of GZR18 Injection in Chinese subjects with obesity/overweight after multiple administration on a once-weekly (QW) or bi-weekly (Q2W) dosing interval. A total of 36 obese participants were enrolled in the study and randomized in a 3:1 ratio to receive a dose titration of 1.5 mg to 30 mg of GZR18 Injection or a matching placebo for a total of 35 weeks.
The study results demonstrated a superior efficacy of GZR18 Injection than placebo for weight reduction in Chinese obese subjects. After 35 weeks of treatment, the mean weight change from baseline in the GZR18 QW group was -16.5 kg (95% CI: -19.9 kg, -13.1 kg); the placebo-adjusted mean percent weight change from baseline was -18.6% (95% CI: -25.5%, -11.6%). Although it was not a head-to-head study, when compared to the published data on weight reduction of similar products currently available on the market, GZR18’s weight-reducing ability outperformed Semaglutide and dual-incretin receptor targeted Tirzepatide in similar study duration. Meanwhile, the mean weight change from baseline in the GZR18 Q2W group was -11.3 kg (95% CI: -15.4 kg, -7.2 kg); the placebo-adjusted mean percent weight change from baseline was -13.5% (95% CI: -21.0%, -6.0%).
In addition, the percentage of participants achieving weight reductions of ≥5%, 10%, and 15% from baseline were 100.0%, 90.0%, and 80.0%, respectively, in the GZR18 QW group, and the percentage of participants achieving weight reductions of ≥5%, 10%, and 15% from baseline were 71.4%, 71.4%, and 42.9%, respectively, in the GZR18 Q2W group. No participant in the placebo group achieved a weight reduction of 5% and above.
In terms of safety, GZR18 Injection was well tolerated in obese participants. The most commonly reported adverse events (AE) during treatment were gastrointestinal related AEs, and all were mild to moderate in severity. This is consistent with the incretin-based therapies approved for the treatment of obesity and overweight and occurred mainly in the early dose-escalation period. There were no serious hypoglycemic events in this study and no serious adverse events related to the investigational drug.
