Obese or overweight participants receiving bi-weekly doses of 12 mg, 18 mg, 24 mg, 48 mg, and once-weekly dose of 24 mg GZR18 for 30 weeks achieved mean percent changes in body weight from baseline of -11.15%, -13.22%, -14.25%, -17.29%, and -17.78%, respectively, with the placebo group at -0.99%; and at 30 weeks, participants' body weight continued to decrease.
l The clinical efficacy and safety of bi-weekly 48 mg and once-weekly 24 mg GZR18 injections were comparable, with no significant difference in mean percent change in body weight from baseline between the two groups (one-sided test, P > 0.025).
GZR18 injections were safe and well tolerated, with the most commonly reported adverse events being gastrointestinal reactions, comparable to similar drugs.
Beijing, China, November 11, 2024 -Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) 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.
Statement:
1. GZR18 is an investigational drug and is not approved for use in any country.
2. Gan & Lee Pharmaceuticals does not endorse the use of any unapproved drug or indication.
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 (BMI≥28 kg/m²) or overweight (BMI≥24 kg/m²) with at least one weight-related comorbidity and whose weight was poorly controlled by diet and exercise. Participants were randomly assigned to receive 12 mg (n=52), 18 mg (n=53), 24 mg (n=52), 48 mg (n=64) GZR18 injections bi-weekly, or 24 mg (n=53) once-weekly GZR18 injection, or placebo (n=66) for 30 weeks (including a dose escalation period). 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 injection, with weight loss not yet reaching a plateau. In the Q2W 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. In the QW 24 mg group, participants experienced a weight reduction of 17.78% (1.01), while the placebo group showed only a -0.99% (0.91) change. Moreover, there was no significant difference in efficacy between the 48 mg Q2W and 24 mg QW groups (one-sided test P>0.025). In the 48 mg Q2W GZR18 group, the proportions of participants achieving ≥5%, 10%, and 20% weight loss were 97.8%, 82.2%, and 37.8%, respectively.
GZR18 injection was safe and well tolerated, with the most common adverse events being mild to moderate gastrointestinal reactions. 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.
Dr. Zhong-ru Gan, Chairman of Gan & Lee Pharmaceuticals, commented:
“The results of this Phase 2b study further validate the excellent performance of GZR18 injection in weight management, particularly with the bi-weekly dosing regimen, which has shown comparable efficacy to the once-weekly regimen. The bi-weekly formulation of GLP-1 has the potential to enhance patient adherence, thereby improving long-term weight management outcomes. GZR18 injection, as the first single-target GLP-1 biweekly formulation, clinical data has demonstrated weight loss effects comparable to or even better than multi-target GLP-1 once-weekly formulations, providing new insights for the future development of GLP-1 drugs. The development of the bi-weekly GZR18 injection is expected to offer more flexible treatment options for patients with obesity, and we look forward to further validating these findings in the upcoming Phase 3 clinical trials.”
Forward-looking statements
Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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