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速递|头对头司美格鲁肽!信达生物玛仕度肽3期临床完成首例受试者给药

Core Viewpoint - The article discusses the completion of the first patient dosing in a Phase III clinical trial (GLORY-3) for the dual receptor agonist, Masitide, in overweight or obese patients with Metabolic Associated Fatty Liver Disease (MAFLD) in China [1][2]. Group 1: Clinical Study Overview - The GLORY-3 study is a multicenter, randomized, open-label Phase III trial comparing the efficacy and safety of Masitide (9 mg) with Semaglutide (2.4 mg) in approximately 470 overweight or obese participants (BMI ≥ 27 kg/m²) with MAFLD [2]. - The primary endpoints include the percentage change in liver fat content assessed by MRI-PDFF from baseline at 48 weeks and the percentage change in body weight from baseline at 48 weeks [2]. Group 2: Efficacy Results - In a Phase II study involving obese participants (BMI ≥ 30 kg/m²), the Masitide 9 mg group showed a weight reduction of -18.6% compared to the placebo group, with an average weight change of -17.8 kg [3]. - Among participants with a baseline liver fat content exceeding 5%, the Masitide 9 mg group demonstrated a 73.3% average percentage decrease in liver fat content after 24 weeks, which was maintained at 48 weeks [3]. Group 3: Clinical Significance - MAFLD is the most common chronic liver disease globally and has replaced viral hepatitis as the leading chronic liver disease in China, with an MAFLD prevalence of 81.8% among the obese population [4]. - GLP-1 receptor agonists like Semaglutide are recommended for the treatment of obesity with MAFLD, and Masitide, as a dual receptor agonist, is expected to provide significant benefits in reducing liver fat and enzyme levels [4][5].