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March 1, 2026Signal Transduction and Targeted Therapy3 citationsOpen Access

Efficacy and safety of bofanglutide, a GLP-1 receptor agonist, in Chinese adults with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial

LJLinong JiLGLeili GaoJTJunhang Tian

Key Points

  • This trial aims to evaluate the efficacy and safety of bofanglutide in adults with overweight or obesity.
  • Randomized, double-blind, placebo-controlled phase 2b trial design.
  • 340 participants with overweight or obesity received bofanglutide or placebo in various dose groups.
  • Participants were assessed for changes in body weight from baseline to week 30.
  • Mean percentage weight loss with bofanglutide ranged from −9.75% to −16.69%, compared to −1.15% with placebo.
  • Adverse events occurred in 98.9% of the bofanglutide group, primarily mild gastrointestinal issues.
  • Bofanglutide is generally well tolerated with significant weight reduction effects.

Abstract

Abstract Bofanglutide is a novel biweekly (once every two weeks; Q2W) glucagon-like peptide-1 receptor agonist. We evaluated the efficacy and safety of bofanglutide in Chinese adults with overweight or obesity in a randomized, double-blind, placebo-controlled phase 2b trial (ClinicalTrials.gov, NCT06256562). Adults with overweight (body mass index BMI ≥24, <28 kg/m 2 ) and at least one weight-related comorbidity, or obesity (BMI ≥ 28 kg/m 2 ), were randomly assigned to five dose groups: 12 mg Q2W, 18 mg Q2W, 24 mg Q2W, 48 mg Q2W, and 24 mg once weekly (QW), with randomization to bofanglutide or placebo within each dose group. The primary endpoint was the percentage change in body weight from baseline to week 30. Between June 8, 2023, and June 5, 2024, 340 participants (185 54.4% male; mean age, 33.1 years; mean body weight, 95.6 kg; mean BMI, 33.2 kg/m²) were randomized into the following groups: bofanglutide 12 mg Q2W ( n = 52), 18 mg Q2W ( n = 53), 24 mg Q2W ( n = 52), 48 mg Q2W ( n = 64), 24 mg QW ( n = 53), or placebo ( n = 66). Overall, 286 participants (84.1%) completed the trial. The mean percentage change in body weight from baseline to week 30 ranged from −9.75% to −16.69% with bofanglutide, compared with −1.15% with placebo (all p < 0.001 versus placebo). Adverse events occurred in 98.9% (271/274) of the bofanglutide group versus 86.4% (57/66) of the placebo group and were mostly grade 1–2 gastrointestinal events (83.9% 230/274 with bofanglutide and 33.3% 22/66 with placebo). Bofanglutide is generally well tolerated and has a robust ability to reduce body weight.

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Cite This Study

Ji et al. (2026) studied this question.

synapsesocial.com/papers/69a3d830ec16d51705d2ed57https://doi.org/10.1038/s41392-026-02586-8
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