Gan & Lee Pharmaceuticals announced that the results of the Phase 2b clinical study of GZR18 injection, a bi-weekly (twice a month) glucagon-like peptide-1 (GLP-1) receptor agonist independently developed by the company, in adult overweight/obese patients in China were presented as an oral presentation at ObesityWeek®? 2024. The Phase 2b clinical trial (CTR20231695) was a multicenter, randomized, double-blind, placebo-controlled, dose-finding study designed to evaluate the efficacy and safety of bi-weekly (Q2W) and once-weekly (QW) dosing regimens of GZR18 injection.
The study enrolled a total of 340 participants, all of whom were obese (BMI28 kg/m2) or overweight (BMI24 kg/m2) with at least one weight-related comorbidity and whose weight was poorly controlled by diet and exercise. The primary efficacy endpoint was the percentage change in body weight from baseline after 30 weeks of treatment. The study results showed a significant reduction in body weight from baseline at week 30 in participants receiving different doses and dosing frequencies of GZR18 injections, with weight loss not yet reaching a plate.
In the second quarter of 2024 GZR18 dose groups, participants experienced dose-dependent weight loss: 11.15% (1.04) in the 12 mg group, 13.22% (0.95) in the 18 mg group, 14.25% (1.01) in the 24 mg group, and 17.29% (0.99) in the 48 mg group. No serious adverse events were reported in any treatment group. Trial data are presented as mean (standard error).
The detailed results of the Phase 2b study of GZR18 Injection will be published in a peer-reviewed journal.
