Core Viewpoint - The article discusses the development and clinical research of HRS9531, a GLP-1/GIP dual receptor agonist, highlighting its potential in treating obesity and type 2 diabetes mellitus (T2DM) as global rates of these conditions rise [2]. Group 1: Research Findings - Research 1: HRS9531 injection showed a significant average weight loss of 22.8% in the treatment group compared to 1.7% in the placebo group after 36 weeks, with a difference of 21.1% (P<0.0001) [6]. - Research 2: In a 52-week study, HRS9531 maintained an average weight loss of up to 18.0% at week 32, while the placebo group experienced a weight gain of 0.74% [11]. - Research 3: The oral version of HRS9531 demonstrated good tolerability and a weight loss of 3.8 kg in the 10 mg group after 28 days, compared to 1.6 kg in the placebo group [17]. Group 2: Safety and Tolerability - In the first study, the adverse event rate was 91.8% for the HRS9531 group, primarily involving mild gastrointestinal issues, with no patients discontinuing treatment [7]. - The second study reported adverse event rates between 75.5% to 91.8% across different dosage groups, with no new safety risks identified [12]. - The oral formulation showed a total adverse event rate of 62.5% in the single-dose phase and 84.4% in the multiple-dose phase, with no severe adverse events reported [17]. Group 3: Future Outlook - HRS9531 is positioned as a leading candidate in the clinical development of GLP-1/GIP dual receptor agonists in China, with significant potential for managing obesity and T2DM [19]. - The dosing strategy indicates that switching to a bi-weekly administration after achieving initial weight management goals can maintain efficacy and improve long-term adherence [20]. - The development of the oral formulation fills a gap in the domestic market for GLP-1/GIP agents, supporting its broader application in metabolic disease treatment [20].
速递|36周减重22.8%,恒瑞减肥药物三项研究亮相,从注射到口服全面布局