Department of Endocrinology, Endocrine and Metabolic Disease Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.
Branch of National Clinical Research Centre for Metabolic Diseases, Nanjing, China.
Nat Commun. 2024 Sep 27;15(1):8408. doi: 10.1038/s41467-024-52353-y.
Glucagon-like peptide-1 (GLP-1) analogs are important therapeutics for type 2 diabetes and obesity. Ecnoglutide (XW003) is a novel, long-acting GLP-1 analog. We conducted a Phase 2, randomized, double-blind, placebo-controlled study enrolling 145 adults with T2DM. Participants were randomized to 0.4, 0.8, or 1.2 mg ecnoglutide or placebo as once-weekly injections for 20 weeks. The primary objective was to evaluate the efficacy of ecnoglutide, as measured by HbA1c change from baseline at Week 20. Secondary endpoints included body weight, glucose and lipid parameters, as well as safety. We show that, at end of treatment, the 0.4, 0.8, and 1.2 mg groups had statistically significant HbA1c reductions from baseline of -1.81%, -1.90%, and -2.39%, respectively, compared to -0.55% for placebo (P < 0.0001). At end of treatment, 71.9% of the 1.2 mg group had HbA1c ≤ 6.5% versus 9.1% on placebo, and 33.3% had body weight reductions ≥5% versus 3.0% for placebo. Ecnoglutide was generally safe and well tolerated. China Drug Trials Registry CTR20211014.
胰高血糖素样肽-1（GLP-1）类似物是治疗 2 型糖尿病和肥胖症的重要药物。艾塞那肽（XW003）是一种新型长效 GLP-1 类似物。我们进行了一项 2 期、随机、双盲、安慰剂对照研究，纳入了 145 名 2 型糖尿病成人患者。参与者随机接受 0.4、0.8 或 1.2mg 艾塞那肽或安慰剂作为每周一次的注射，治疗 20 周。主要目的是评估艾塞那肽的疗效，以 20 周时的 HbA1c 从基线的变化来衡量。次要终点包括体重、血糖和血脂参数以及安全性。我们表明，在治疗结束时，0.4、0.8 和 1.2mg 组与安慰剂组（-0.55%）相比，HbA1c 从基线分别有统计学意义的降低，分别为-1.81%、-1.90%和-2.39%（P<0.0001）。在治疗结束时，1.2mg 组有 71.9%的患者 HbA1c≤6.5%，而安慰剂组为 9.1%，有 33.3%的患者体重减轻≥5%，而安慰剂组为 3.0%。艾塞那肽通常是安全且耐受良好的。中国临床试验注册中心 CTR20211014。
