China-based Gan & Lee Pharmaceuticals (Shanghai Stock Exchange: 603087) announced on Saturday 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 randomised, double-blind, placebo-controlled, dose-escalation Phase 1b/2a clinical study assessed 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. The study enrolled a total of 36 obese participants and randomised them in a 3:1 ratio to receive a dose titration of 1.5mg to 30mg of GZR18 Injection or a matching placebo for a total of 35 weeks.

The study results indicated a superior efficacy of GZR18 Injection over placebo for weight redution in Chinese obese subjects. After 35 weeks of treatment, the mean weight change from baseline in the GZR18 QW group was -16.5kg (95% CI: -19.9kg, -13.1kg); the placebo-adjusted mean percent weight change from baseline was -18.6% (95% CI: -25.5%, -11.6%). The mean weight change from baseline in the GZR18 Q2W group was -11.3kg (95% CI: -15.4kg, -7.2kg); the placebo-adjusted mean percent weight change from baseline was -13.5% (95% CI: -21.0%, -6.0%). The percentage of subjects achieving weight reductions of greater than or equal to 5%, 10%, and 15% from baseline were 100.0%, 90.0 percent, and 80.0%, respectively, in the GZR18 QW group, and the percentage of participants achieving weight reductions of greater than or equal to 5% 10%, and 15% from baseline were 71.4%, 71.4%, and 42.9%, respectively, in the GZR18 Q2W group. In the placebo group, no participant achieved a weight reduction of 5% and above.

Dr. Gan Zhong-ru, Gan & Lee founder, said, 'We are very excited about the clinical results of the GZR18 program to the present day. Our unique molecular design delays the onset of drug action and attenuates the peak effect, thereby improving drug tolerability and achieving smooth and sustained weight loss in a stepwise manner. Moreover, GZR18 has a longer duration of action, which is expected to be administered once every two weeks. Meanwhile, we hope that the clinical results of GZR18 will provide more evidence to reveal the mechanism of action of different targets of Incretins and Glucagon.'