Gan & Lee Starts US Phase 2 Trial of Bofanglutide for Obesity

BEIJING and BRIDGEWATER, N.J., March 10, 2025 – Gan & Lee Pharmaceuticals has announced the successful initiation of a Phase 2 clinical trial involving their innovative treatment, bofanglutide (GZR18) injection. This clinical research marks a significant step in the development of this bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), specifically designed for individuals in the United States dealing with overweight or obesity.

Bofanglutide distinguishes itself by being the first GLP-1 receptor monotherapy subjected to a direct comparison with the leading therapy, tirzepatide, in terms of effectiveness in managing body weight. This groundbreaking trial, registered under ClinicalTrials.gov as NCT06737042, aims to assess both the efficacy and safety profile of bofanglutide in American adults battling weight issues. A total of 285 participants will be randomly assigned different treatment regimens: bi-weekly doses of 24 mg, 36 mg, or 48 mg of bofanglutide, a weekly 15 mg dose of tirzepatide, or a placebo. The trial's primary measure of success is the percentage reduction in body weight from the onset to the conclusion of the treatment period.

Earlier research into bofanglutide, detailed in Phase 1 study NCT06548997, indicated that the injection was well-tolerated by American participants, showing great promise in both lowering glucose levels and promoting weight loss. The transition into a head-to-head clinical study against tirzepatide is a pivotal moment for Gan & Lee, marking their commitment to pushing boundaries in GLP-1 therapy innovation. This endeavor underscores the company's strategic goal to compete with leading global weight management solutions and to improve treatment choices available to patients struggling with excess weight.

Bofanglutide (GZR18) is a promising bi-weekly GLP-1 RA, crafted by Gan & Lee Pharmaceuticals. It is intended for controlling blood sugar in adults with type 2 diabetes and aiding weight management in those with overweight or obesity. As a potential pioneer in the bi-weekly GLP-1 RA category, bofanglutide's early clinical trials have shown its weight-loss effectiveness to be on par with or superior to existing products, maintaining a safety and tolerability profile consistent with that of its established class. It also achieves significant decreases in both blood sugar levels and body weight.

Gan & Lee Pharmaceuticals has established itself as a leader in diabetes treatment, developing the first insulin analog in China. Their product line includes six core insulin offerings, featuring five insulin analogs and one human insulin. Key products include Basalin, Prandilin®™, Rapilin, Prandilin®™25, Rapilin30, and Similin30, alongside two approved medical devices, GanleePen and GanleeFine®. In the 2024 National Insulin-Specific Centralized Procurement in China, they topped the list in demand for insulin analogs.

In recent years, Gan & Lee has expanded its reach beyond China's borders. In 2020, the US Food and Drug Administration (FDA) approved their disposable pen needle, GanleeFine, and in 2024, they received Good Manufacturing Practice (GMP) certification from the European Medicines Agency (EMA). These accomplishments enhance the company's competitive edge in both international and domestic spheres.

Looking ahead, Gan & Lee plans to broaden its influence in diabetes care, aspiring to become a world-class pharmaceutical entity. Their future initiatives include the development of new chemical entities and biological drugs, with a focus on treating metabolic and cardiovascular diseases, among other medical conditions. With these efforts, Gan & Lee continues to solidify its role as a key player in advancing global healthcare solutions.