The first participant has been successfully dosed in Gan & Lee Pharmaceuticals’ Phase 2 clinical trial of bofanglutide (GZR18) injection, a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), in the US participants with overweight or obesity. Notably, bofanglutide is the first GLP-1 receptor mono-agonist to undergo a head-to-head comparison with tirzepatide for evaluating the efficacy in body weight management globally.
This Phase 2 clinical trial was designed to evaluate the efficacy and safety of bofanglutide injection in US adults with overweight or obesity. The study plans to enrol 285 subjects, who will be randomised to receive either 24mg, 36mg or 48mg of bofanglutide bi-weekly, 15mg of tirzepatide once-weekly or placebo. The primary endpoint is the percentage change in body weight from baseline at the end of the treatment.
A previous Phase 1 study of bofanglutide injection demonstrated good safety and tolerability in US subjects, along with promising glucose-lowering and weight-loss potential (Liu Y et al. The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. Diabetes Obes Metab. Mar 2025).
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