Core Insights - Eli Lilly plans to submit a marketing application for efsitora, an insulin treatment for adult patients with type 2 diabetes (T2DM), to global regulatory authorities by the end of this year [1] Group 1: Clinical Trial Results - The company announced detailed results from three Phase 3 clinical studies: QWINT-1, QWINT-3, and QWINT-4 [1] - These studies evaluated the efficacy and safety of efsitora alfa administered once weekly compared to daily basal insulin in T2DM adult patients [1] - All studies achieved their primary endpoints, demonstrating that weekly efsitora is non-inferior to daily basal insulin in reducing hemoglobin A1C levels [1]

整理 | GLP1减重宝典内容团队 在2022年国际糖尿病联盟（IDF）大会上，首次以墙报形式展示了PIONEER 11和PIONEER 12研究的结果。这两项研究以中国人群为 主，为司美格鲁肽片（商品名：诺和忻）在中国的获批提供了重要支持。该药物的治疗剂量为7mg或14mg，适用于在饮食和运动控制 不足的基础上，作为单药或与二甲双胍和/或磺脲类药物联合治疗的成人2型糖尿病（T2DM）患者。 与欧美人群不同，中国的2型糖尿病患者通常在较年轻时就被诊断，且BMI较低，这可能影响药物的治疗效果，因此中国研究是必要 的。 在中国人群中，司美格鲁肽片的疗效和安全性数据相对较少，PIONEER 11和12研究则为该领域提供了重要的临床数据。 PIONEER系列的全球3期临床试验比较了司美格鲁肽片与活性对照药物及安慰剂在降糖效果和安全性上的差异，以及体重的减轻，结果 显示，司美格鲁肽片能够持续改善血糖控制以及减重，且效果优于活性对照药物和安慰剂。 ▍PIONEER 11 单药治疗 PIONEER 11研究在饮食和运动控制不佳的中国2型糖尿病患者中，评估了司美格鲁肽片单药治疗的有效性与安全性。研究结果显示， 中国 人群的临 ...

Core Viewpoint - A new meta-analysis indicates that GLP-1 receptor agonists, used for treating type 2 diabetes and aiding weight loss, may significantly reduce the risk of developing any form of dementia [2][4]. Group 1: Study Overview - The study, led by Catriona Reddin from Galway University, reviewed 26 randomized clinical trials involving over 160,000 participants, providing further evidence of the cognitive improvement potential of GLP-1 drugs [2][4]. - Participants in the trials were type 2 diabetes patients who had not been diagnosed with dementia or cognitive impairment, and they were followed for at least six months [4]. Group 2: Findings and Comparisons - The results showed that the incidence of dementia or cognitive decline was significantly lower in the group using GLP-1 drugs compared to the placebo group [4]. - Previous observational studies suggested a slight reduction in dementia risk associated with GLP-1 drugs, but this meta-analysis provides stronger evidence through controlled clinical trials [2][4]. Group 3: Mechanisms and Implications - The protective effects of GLP-1 drugs may not solely be due to blood sugar control, as SGLT2 inhibitors did not show a significant correlation with dementia risk [7]. - GLP-1 drugs have been found to possess anti-inflammatory properties, which may help mitigate chronic neuroinflammation, a significant factor in dementia [11][12]. - These drugs may also positively impact cardiovascular health, potentially reducing dementia risk related to vascular issues [12]. Group 4: Future Research and Recommendations - While the findings are promising, experts caution against prescribing GLP-1 drugs solely for dementia prevention without further large-scale studies specifically targeting dementia [15]. - Ongoing clinical trials are investigating the use of semaglutide for early Alzheimer's treatment, with results expected later this year [16].

近日，中国研究型医院学会糖尿病学专业委员会组织编写的《胰高糖素样肽1受体激动剂联合胰岛素治 疗2型糖尿病专家共识(2025版)》在《中华糖尿病杂志》发表，翰森制药聚乙二醇洛塞那肽注射液(商品 名：孚来美)成功纳入推荐，助力2型糖尿病联合治疗革新。 在我国，胰岛素被广泛应用于糖尿病治疗，但低血糖和体重增加是常见且不容忽视的不良反应。胰高糖 素样肽1受体激动剂(GLP-1RA)与胰岛素联合，可针对2型糖尿病(T2DM)多种病理生理缺陷干预，不仅 能显著增强降糖效果，减少每日胰岛素用量，还能降低体重增加和低血糖风险，已成为临床常用联合治 疗方案。《胰高糖素样肽1受体激动剂联合胰岛素治疗2型糖尿病专家共识(2025版)》旨在规范这一联合 治疗方案的临床应用，为基层医师提供科学权威的参考和指导。 共识指出，足量GLP-1RA联合胰岛素，可为患者带来心血管及肾脏保护等额外获益，无论日制剂还是 周制剂，都能显著降低糖化血红蛋白(HbA1c)水平，提高血糖达标率。此外，基于空腹C肽的T2DM分型 为精准治疗提供了便捷途径，GLP-1RA适配不同T2DM分型的精准治疗方案。 孚来美是我国首个自主研发的GLP-1RA周制剂、全球 ...

Core Viewpoint - Junsheng Tai Pharmaceutical-B (02511) has announced that its self-developed intestinal and hepatic anti-inflammatory and metabolic regulator, HTD1801, has achieved primary efficacy endpoints and multiple secondary efficacy endpoints in two Phase 3 clinical trials for Type 2 Diabetes Mellitus (T2DM) patients [1][2]. Group 1: Clinical Trial Results - The SYMPHONY 1 and SYMPHONY 2 trials are multi-center, randomized, double-blind, placebo-controlled Phase 3 studies aimed at evaluating the efficacy and safety of HTD1801 in T2DM patients with poor blood glucose control after dietary and exercise interventions (SYMPHONY 1; N=407) and those with inadequate control on metformin (SYMPHONY 2; N=549) [2]. - The primary efficacy endpoint for both studies was the change in glycated hemoglobin (HbA1c) from baseline after 24 weeks of treatment compared to placebo, with secondary endpoints including the percentage of subjects achieving HbA1c <7.0%, fasting plasma glucose (FPG), low-density lipoprotein cholesterol (LDL-C), gamma-glutamyl transferase (GGT), and high-sensitivity C-reactive protein (hs-CRP) [2]. Group 2: Efficacy and Safety Profile - After 24 weeks of treatment, the proportion of patients achieving HbA1c <7.0% in the HTD1801 group was significantly higher than in the placebo group, with HTD1801 also showing significant reductions in both postprandial and fasting blood glucose levels [3]. - HTD1801 demonstrated the ability to lower both glucose and lipids, significantly reducing LDL-C and non-HDL-C levels, as well as inflammatory markers GGT and hs-CRP, which are closely related to cardiovascular events and clinical outcomes in T2DM patients [3]. - Both studies indicated that HTD1801 exhibited good safety and tolerability, with the most common adverse events being gastrointestinal in nature, consistent with previous clinical findings, and less than 2% of subjects discontinued due to adverse events, with no significant risk of hypoglycemia observed [3].