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<p>Efsubaglutide alfa, a long-acting humanised GLP-1 receptor agonist, was evaluated as add-on therapy to metformin in adults with type 2 diabetes. In an operationally seamless adaptive phase 2b/3, randomised, double-blind, placebo-controlled trial, phase 2b randomised participants 1:1:1 to Efsubaglutide 1 mg, 3 mg, or placebo for 12 weeks; based on phase 2b efficacy and safety, an independent committee selected 3 mg as the recommended phase 3 dose. Phase 3 randomised new participants 1:1 to Efsubaglutide 3 mg or placebo for 24-week double-blind treatment, followed by a 28-week open-label extension. At week 12 in phase 2b, HbA1c decreased by 1.10% with 1 mg and 1.43% with 3 mg (both <i>p</i> &lt; <i>0.0001</i>). At week 24 in phase 3, HbA1c decreased by 1.80% with Efsubaglutide 3 mg versus 0.74% with placebo (estimated treatment difference, −1.06%; <i>p</i> &lt; <i>0.001</i>). Adverse events were predominantly mild to moderate gastrointestinal events. Trial registration: ClinicalTrials.gov NCT04998032.</p>

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Efsubaglutide alfa added to metformin improves glycaemia with β-cell functional responses in type 2 diabetes: a randomised, double-blind, placebo-controlled, two-stage adaptive phase 2b/3 trial (SUPER 2)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月8日

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  • Weiping Jia,
  • Fei Gao,
  • Jingyi Lu,
  • Zhifeng Cheng,
  • Xiaolin Dong,
  • Xiaoxia Shi,
  • Xiuhai Su,
  • Liping Li,
  • Wei Zhang,
  • Yihua Wang,
  • Jianhua Ma,
  • Shu Li,
  • Haifang Wang,
  • Lin Cheng,
  • Li Mao,
  • Chengyan Jiang,
  • Qingju Li,
  • Xing Li,
  • Xin Zheng,
  • Ming Liu,
  • Jiao Sun,
  • Hui Peng,
  • Huanfeng Pan,
  • Hongwei Ling,
  • Chengxia Jiang,
  • Junhua Song,
  • Xinhuan Zhang,
  • Lili Zhang,
  • Yang Liu,
  • Tianshu Zeng,
  • Yongcai Zhao,
  • Yulong Xu,
  • Yiming Li,
  • Yuqian Bao,
  • Jian Zhou,
  • Qinghua Wang

摘要

Efsubaglutide alfa, a long-acting humanised GLP-1 receptor agonist, was evaluated as add-on therapy to metformin in adults with type 2 diabetes. In an operationally seamless adaptive phase 2b/3, randomised, double-blind, placebo-controlled trial, phase 2b randomised participants 1:1:1 to Efsubaglutide 1 mg, 3 mg, or placebo for 12 weeks; based on phase 2b efficacy and safety, an independent committee selected 3 mg as the recommended phase 3 dose. Phase 3 randomised new participants 1:1 to Efsubaglutide 3 mg or placebo for 24-week double-blind treatment, followed by a 28-week open-label extension. At week 12 in phase 2b, HbA1c decreased by 1.10% with 1 mg and 1.43% with 3 mg (both p < 0.0001). At week 24 in phase 3, HbA1c decreased by 1.80% with Efsubaglutide 3 mg versus 0.74% with placebo (estimated treatment difference, −1.06%; p < 0.001). Adverse events were predominantly mild to moderate gastrointestinal events. Trial registration: ClinicalTrials.gov NCT04998032.