Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that the first participant has been successfully dosed in a Phase 2 clinical trial of bofanglutide (research code: GZR18) injection, a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) independently developed by Gan & Lee, 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 (ClinicalTrials.gov registration number: NCT06737042) was designed to evaluate the efficacy and safety of bofanglutide injection in US adults with overweight or obesity. The study plans to enroll 285 subjects, who will be randomized to receive either 24 mg, 36 mg, or 48 mg of bofanglutide bi-weekly, 15 mg of tirzepatide once-weekly, or placebo. The primary endpoint is the percentage change in body weight from baseline at the end of the treatment.

Previously, a Phase 1 study (NCT06548997) of bofanglutide injection demonstrated good safety and tolerability in US subjects, along with promising glucose-lowering and weight-loss potential^[1]. The initiation of head-to-head clinical study for bofanglutide versus tirzepatide, marking a new phase in Gan & Lee's GLP-1 innovation. This milestone underscores the company's ambition to challenge the leading GLP-1 therapy in the global market for weight management, aiming to provide a better treatment option for patients with overweight or obesity worldwide.