Gan & Lee Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for GZR18 Injection. This clearance allows Gan & Lee to proceed with a Phase 2 clinical trial in the United States, directly comparing GZR18 to Tirzepatide for chronic weight management in obese or overweight patients, with or without type 2 diabetes (T2DM). The trial is registered under NCT06737042.
GZR18 is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (RA). As a bi-weekly GLP-1 mono-agonist formulation, GZR18 represents a novel approach to obesity treatment. Current clinical data suggests that GZR18 can achieve weight loss effects comparable to, or even better than, multi-target once-weekly GLP-1 formulations.
Obesity Crisis and the Role of GLP-1 RAs
The World Obesity Federation (WOF) Global Obesity Report (2024) indicates that approximately 2.2 billion adults worldwide were overweight (BMI ≥ 25kg/m2) in 2020, representing about 42% of the adult population. Projections estimate this number will rise to 3.3 billion by 2035. Obesity is associated with numerous complications, including diabetes, cardiovascular diseases, and mental health disorders, placing a substantial burden on healthcare systems.
GLP-1 receptor agonists like GZR18 offer a therapeutic strategy by delaying gastric emptying and enhancing satiety through activation of GLP-1 receptors in the gastrointestinal tract and hypothalamus. This mechanism helps to suppress appetite and reduce body weight.
Clinical Development of GZR18
GZR18 is under development for both type 2 diabetes and chronic weight management. Clinical data has demonstrated that administering GZR18 once a week or every two weeks can effectively lower blood sugar levels and promote weight loss. A Phase Ib/IIa trial showed that GZR18 induced an 18.6% weight reduction in subjects with obesity.
The bi-weekly administration schedule of GZR18 aims to provide more flexible treatment options for patients, potentially improving long-term weight management efficacy and adherence to therapy.
Gan & Lee Pharmaceuticals, known for developing the first Chinese domestic insulin analog, is expanding its focus to include treatments for metabolic and cardiovascular diseases.
