中日友好医院杨文英团队的研究开发出了中国成人2型糖尿病患者的马度肽与杜拉鲁肽对比研究。该研究于2025年12月17日发表于国际一流学术期刊《自然》杂志上。

Mazdutide是一种每周一次的胰高血糖素和胰高血糖素样肽-1受体双重激动剂，用于治疗2型糖尿病（T2D）。本研究评估了马度肽与杜拉鲁肽对T2D患者口服降糖药的疗效和安全性。在这项随机化的3期研究中，731名T2D患者以1:1:1的比例随机分配，接受4 mg、6 mg或1.5 mg的马度肽治疗，持续28周。从基线到第28周，两种剂量的马祖特肽在HbA1c的平均变化方面均表现出非劣效性和优越性，与杜拉鲁肽1.5 mg相比，马祖特胺4 mg和6 mg的最小二乘法（LS）平均治疗差异分别为-0.24%（p=0.0032）和-0.30%（p=0.0003）。与杜拉鲁汀相比，马祖特肽的体重减轻幅度明显更大，马祖德4 mg的LS平均治疗差异为-3.78%和-5.76%（均p<0.0001）。

此外，与杜拉鲁肽1.5 mg相比，在第28周，更多的受试者达到了HbA1c < 7.0%的复合终点，体重减轻≥5% （p < 0.0001）。最常见的治疗不良事件是腹泻、腹泻和呕吐。他们的研究结果显示，在中国T2D患者中，与服用1.5 mg的杜拉鲁肽相比，服用28周的马度肽（4mg和6mg）可显著降低HbA1c和体重。马度肽总体上是安全的，胃肠道不良事件的发生率高于杜拉鲁肽。

附：英文原文

Title: Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes

Author: Guo, Lixin, Zhang, Bo, Xue, Xia, Zhang, Xin, Cai, Hanqing, Jiang, Hongwei, Zhang, Lili, Jin, Ping, Wang, Xiaojing, Cheng, Zhifeng, Zhang, Suhe, Geng, Jianlin, Guo, Yushan, Hu, Hanbo, Ma, Qingyang, Li, Li, Du, Haiwei, Han-Zhang, Han, Xue, Fengtai, Deng, Huan, Qian, Lei, Yang, Wenying

Issue&Volume: 2025-12-17

Abstract: Mazdutide is a once-weekly glucagon and glucagon-like peptide-1 receptor dual agonist developed for the treatment of type 2 diabetes (T2D) 1. This study assessed the efficacy and safety of mazdutide versus dulaglutide in participants with T2D on background oral anti-diabetic drugs. In this randomised phase 3 study, 731 participants with T2D were randomised 1:1:1 to receive mazdutide 4 mg, mazdutide 6 mg or dulaglutide 1.5 mg for 28 weeks. Both mazdutide doses demonstrated non-inferiority and superiority to dulaglutide 1.5 mg in mean change in HbA1c from baseline to week 28, with the least squares (LS) mean treatment difference of 0.24% (p=0.0032) for mazdutide 4 mg and 0.30% (p=0.0003) for mazdutide 6 mg vs dulaglutide 1.5 mg. Significantly greater weight reductions were achieved with mazdutide versus dulaglutide, with LS mean treatment difference of 3.78% for mazdutide 4 mg and 5.76% for mazdutide 6 mg vs dulaglutide (both p<0.0001). Moreover, significantly more participants with mazdutide achieved the composite endpoint of HbA1c <7.0% with ≥5% weight reduction vs dulaglutide 1.5 mg at week 28 (both p<0.0001). The most common treatment-emergent adverse events were diarrhoea, nausea, and vomiting. Our findings showed that 28-week treatment with mazdutide (4 mg and 6 mg) provided superior reductions in HbA1c and body weight compared with dulaglutide 1.5 mg in Chinese participants with T2D. Mazdutide was generally safe, with a higher incidence of gastrointestinal adverse events than dulaglutide.

DOI: 10.1038/s41586-025-10031-z

Source: https://www.nature.com/articles/s41586-025-10031-z