新たな肥満治療薬の第Ⅲ相試験結果をNEJMに発表(China hits milestone in weight-loss drug)

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2025-06-05 北京大学(PKU)

北京大学人民医院の紀立農教授らは、肥満治療薬Mazdutide(GCG/GLP-1デュアル受容体作動薬)の第III相臨床試験結果をNEJM誌に発表しました。Mazdutideは、食欲抑制と代謝促進を同時に行い、体重減少と血糖改善をもたらす新薬で、肝脂肪代謝にも有効です。中国のInnovent社と共同開発され、2025年中に国内販売予定。成人の肥満率が高まる中国で、「健康中国2030」戦略の一環として注目されています。

<関連情報>

肥満または過体重の中国人成人における週1回投与のマズドチド Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight

Linong Ji, M.D., Hongwei Jiang, M.D., Yan Bi, M.D., Hua Li, M.D., Junhang Tian, M.D., Dexue Liu, M.D., Yuzhu Zhao, M.D., +16 , for the GLORY-1 Investigators
New England Journal of Medicine  Published: May 24, 2025
DOI: 10.1056/NEJMoa2411528

Abstract

Background

Evidence suggests that incretin-based dual agonist pharmacotherapy is helpful in persons with obesity. Mazdutide, a glucagon-like peptide-1 and glucagon receptor dual agonist, may have efficacy in persons with overweight or obesity.

Methods

In a phase 3, double-blind, placebo-controlled trial in China, we randomly assigned, in a 1:1:1 ratio, adults 18 to 75 years of age who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 28 or had a BMI of 24 to less than 28 plus at least one weight-related coexisting condition to receive 4 mg of mazdutide, 6 mg of mazdutide, or placebo for 48 weeks. The two primary end points were the percentage change in body weight from baseline and a weight reduction of at least 5% at week 32, as assessed in a treatment-policy estimand analysis (which assessed effects regardless of early discontinuation of mazdutide or placebo and the initiation of new antiobesity therapies).

Results

Among 610 participants, the mean body weight was 87.2 kg and the mean BMI was 31.1 at baseline. At week 32, the mean percentage change in body weight from baseline was –10.09% (95% confidence interval [CI], -11.15 to -9.04) in the 4-mg mazdutide group, –12.55% (95% CI, -13.64 to -11.45) in the 6-mg mazdutide group, and 0.45% (95% CI, -0.61 to 1.52) in the placebo group, and 73.9%, 82.0%, and 10.5% of the participants, respectively, had a weight reduction of at least 5% (P<0.001 for all comparisons with placebo). At week 48, the mean percentage change in body weight from baseline was –11.00% (95% CI, -12.27 to -9.73) in the 4-mg mazdutide group, –14.01% (95% CI, -15.36 to -12.66) in the 6-mg mazdutide group, and 0.30% (95% CI, -0.98 to 1.58) in the placebo group, and 35.7%, 49.5%, and 2.0% of the participants, respectively, had a weight reduction of at least 15% (P<0.001 for all comparisons with placebo). Beneficial effects on all prespecified cardiometabolic measures were seen with mazdutide. The most frequently reported adverse events were gastrointestinal and mostly mild to moderate in severity. The incidence of adverse events leading to discontinuation of the trial regimen was 1.5% with the 4-mg mazdutide dose, 0.5% with the 6-mg mazdutide dose, and 1.0% with placebo.

Conclusions

In Chinese adults with overweight or obesity, once-weekly mazdutide at a dose of 4 mg or 6 mg for 32 weeks led to clinically relevant reductions in body weight. (Funded by Innovent Biologics; GLORY-1 ClinicalTrials.gov number, NCT05607680.)

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