Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced the oral presentation of results from the Phase IIb study for its glucagon-like peptide-1 (GLP-1) receptor agonist, GZR18, at ObesityWeek 2024. The drug is administered once per week and targets the obese or overweight Chinese population.
Study Design and Participant Demographics
The multi-center, randomized, double-blinded, placebo-controlled study aimed to evaluate the efficacy and safety of bi-weekly (Q2W) and once-weekly (QW) dosing regimens of GZR18 injection. A total of 340 subjects, all obese (BMI≥28 kg/m²) or overweight (BMI≥24 kg/m²) with at least one weight-related comorbidity and poorly controlled weight through diet and exercise, were enrolled and randomly assigned to various treatment groups.
Efficacy and Dosage Response
The primary efficacy endpoint was the percentage change in body weight from baseline after 30 weeks of treatment. The study results demonstrated a significant reduction in body weight across different doses and dosing frequencies of GZR18 injection, with weight loss not yet reaching a plateau. Participants in the Q2W GZR18 dose groups experienced dose-dependent weight loss, with the highest dose showing a 17.29% reduction. In the QW 24 mg group, participants experienced a weight reduction of 17.78%, significantly outperforming the placebo group’s -0.99% change.
Key Findings and Proportions of Weight Loss
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. Moreover, there was no significant difference in efficacy between the 48 mg Q2W and 24 mg QW groups, indicating the potential for flexible dosing regimens.-Fineline Info & Tech
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