Core Viewpoint - The article discusses the approval and details of Mazdutide Injection (信尔美®), a drug developed by Innovent Biologics, for long-term weight management in adults with obesity or overweight conditions, specifically targeting those with a BMI of ≥28 kg/m² or ≥24 kg/m² with related comorbidities [2][6]. Drug Information - Drug Name: Mazdutide Injection (信尔美®) [4][22] - Active Ingredient: Mazdutide [20] - Formulation: Clear or nearly clear, colorless or nearly colorless liquid [5][21]. Indications - The drug is indicated for long-term weight control in adults with obesity (BMI ≥28 kg/m²) or overweight (BMI ≥24 kg/m²) with at least one weight-related comorbidity such as high blood sugar, hypertension, dyslipidemia, fatty liver, or obstructive sleep apnea [6][21]. Dosage and Administration - Initial Dose: Recommended starting dose is 2 mg, subcutaneously once a week [8]. - Dose Adjustment: After 4 weeks, the dose can be increased to 4 mg, and if further weight improvement is needed, it can be increased to 6 mg after at least 4 weeks on the current dose [9][10]. - Maintenance Dose: The recommended maintenance dose is either 6 mg or 4 mg, administered weekly [11][12]. Special Populations - Liver Function: No dose adjustment is needed for mild liver impairment; caution is advised for moderate to severe liver impairment due to lack of clinical data [13][28]. - Kidney Function: No dose adjustment is needed for mild to severe kidney impairment, but caution is advised due to limited experience [14][28]. Contraindications - The drug is contraindicated in individuals with known hypersensitivity to the active ingredient or excipients, a history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN2) [15][43]. Common Adverse Reactions - Common adverse reactions include nausea, diarrhea, vomiting, abdominal pain, and injection site reactions [17][32]. The incidence of gastrointestinal adverse reactions was significantly higher in the Mazdutide group compared to the placebo group [34]. Clinical Trial Results - In a Phase III clinical trial (GLORY-1), 610 patients were evaluated, showing significant weight loss compared to placebo at both 32 weeks and 48 weeks [70][71]. The percentage change in weight relative to baseline was -10.1% for the 4 mg group and -12.5% for the 6 mg group at 32 weeks [72]. Cardiovascular Benefits - Mazdutide significantly improved cardiovascular metabolic parameters, including waist circumference, blood pressure, triglycerides, and cholesterol levels, compared to placebo [71]. Conclusion - The approval of Mazdutide Injection represents a significant advancement in the treatment options available for obesity and overweight management, particularly for patients with related comorbidities [2][6].
官方|一文读懂玛仕度肽的使用说明及注意事项(记得转发收藏)
GLP1减重宝典·2025-07-04 10:19