Core Viewpoint - The article discusses the approval of Mazdutide, a dual receptor agonist for GLP-1 and GCG, by China's National Medical Products Administration (NMPA) for long-term weight management in adults with obesity or overweight conditions [2][4]. Summary by Sections Drug Approval and Indications - Mazdutide is approved for adults with a BMI ≥ 28 kg/m² (obesity) or BMI ≥ 24 kg/m² (overweight) with at least one weight-related comorbidity [2]. - The drug is designed to work alongside dietary control and increased physical activity for effective long-term weight management [2]. Mechanism of Action - Mazdutide targets both GLP-1 and GCG receptors, suppressing appetite and enhancing energy expenditure, which helps in weight loss and improves liver fat metabolism [2][4]. Clinical Trial Results - The Phase 3 clinical trial (GLORY-1) published in NEJM demonstrated significant weight loss and safety in Chinese adults [3][4]. - In the trial, participants receiving 4 mg and 6 mg doses of Mazdutide showed average weight reductions of -10.09% and -12.55% at 32 weeks, respectively, with 82.0% of the 6 mg group losing at least 5% of their body weight [8][12]. - At 48 weeks, the weight loss was -11.00% for the 4 mg group and -14.01% for the 6 mg group, with 49.5% of the 6 mg group losing over 15% of their body weight [8][12]. Safety Profile - The most common adverse events were gastrointestinal, mostly mild to moderate, with a low discontinuation rate due to side effects (0.5% for the 6 mg group) [11][12]. - The safety profile of Mazdutide is significantly better compared to similar drugs like Semaglutide and Tirzepatide [11][12]. Additional Benefits - Besides weight loss, Mazdutide showed beneficial effects on cardiovascular metabolic indicators, including a reduction in waist circumference and improvements in blood pressure and triglycerides [10][12]. Significance of Research - This research marks a significant advancement in China's drug development capabilities, being the first innovative drug clinical study in the metabolic and endocrine disease field to be published in a top-tier medical journal [4][13].
刚刚,国产GLP-1类减肥药玛仕度肽获批上市:效果媲美司美格鲁肽,还能改善脂肪肝,且因副作用更低