A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus

开始日期2024-01-03

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

CTR20200114

/ Terminated临床3期

在二甲双胍或与磺酰脲类联用血糖控制仍不佳的T2DM患者中评估efpeglenatide疗效和安全性的双盲、安慰剂对照、随机试验

主要目的证明对于二甲双胍单用或与磺酰脲类（Sulfonylurea，SU）联合使用血糖控制效果仍不佳的二型糖尿病（T2DM）受试者的糖化血红蛋白（glyceted hemoglobin,HbA1c）变化方面，每周一次注射efpeglenatide与安慰剂相比具有优效性，次要目的证明每周注射一次efpeglenatide与安慰剂相比在血糖控制方面具有优效性证明每周注射一次efpeglenatide与安慰剂相比在体重控制方面具有优效性评估每周注射一次efpeglenatide的安全性

开始日期2020-04-27

申办/合作机构

赛诺菲（中国）投资有限公司

NCT03770728

/ Terminated临床3期

A 30-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea

Primary Objective:
To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU).
Secondary Objectives:
* To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on glycemic control.
* To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on body weight.
* To evaluate the safety of once weekly injection of efpeglenatide.

开始日期2019-08-01

申办/合作机构

Sanofi

[+1]

100 项与 Efpeglenatide 相关的临床结果

登录后查看更多信息

100 项与 Efpeglenatide 相关的转化医学

登录后查看更多信息

100 项与 Efpeglenatide 相关的专利（医药）

登录后查看更多信息

项与 Efpeglenatide 相关的文献（医药）

2025-06-09·DIABETES CARE

Effect of Efpeglenatide on Heart Failure Outcomes: A Participant-Level Exploratory Analysis of the Randomized AMPLITUDE-O Trial.

Letter

作者: Gerstein, Hertzel C ; Lam, Carolyn S P ; Lopes, Renato D ; Del Prato, Stefano ; Pratley, Richard ; Rosenstock, Julio ; Sattar, Naveed ; Islam, Shofiqul ; Branch, Kelley R H

2025-04-01·DIABETES OBESITY & METABOLISM

Comparison of the efficacy and safety of GLP‐1 receptor agonists on cardiovascular events and risk factors: A review and network meta‐analysis

Review

作者: Jiang, Linlin ; Zhao, Xuefei ; Zhang, YueHong ; Sun, WenJie ; Lian, Fengmei ; Sun, Yuting ; Gao, Qing ; Kang, Xiaomin ; Wen, Zhige ; An, Xuedong ; Duan, LiYun ; Ji, Hangyu

Abstract:

Objective:

This study aims to systematically evaluate and perform a systematic review and network meta‐analysis comparing the comprehensive cardiovascular protective effects of various glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs), focusing on cardiovascular events and risk factors.

Methods:

We searched PubMed, Embase, Cochrane Library and Web of Science from inception to December 15, 2024. Included studies were published randomized controlled trials (RCTs) comparing GLP‐1RAs to placebo or other GLP‐1RAs. Missing data were standardized, and network meta‐analysis was performed using Stata 17.0. Study heterogeneity, publication bias and evidence quality were assessed using the Cochrane Risk of Bias tool and Confidence in Network Meta‐Analysis (CINeMA).

Results:

As of December 15, 2024, a total of 18 313 articles were retrieved. Based on the inclusion and exclusion criteria, 156 high‐quality studies were included, incorporating 144 782 patients and 14 different GLP‐1RAs. The network meta‐analysis demonstrated low heterogeneity, ensuring the reliability of the results. Comprehensive analysis revealed the following: Efpeglenatide was the most effective in reducing major adverse cardiovascular events. Oral semaglutide shows more significant advantages in reducing all‐cause mortality and cardiovascular mortality. Orforglipron excelled in glycaemic control and weight reduction. SC‐Semaglutide showed the greatest efficacy in lowering both systolic blood pressure and diastolic blood pressure, Liraglutide showed the greatest efficacy in lowering total cholesterol, Noiiglutide in triglycerides and Taspoglutide in low‐density lipoprotein cholesterol, but no GLP‐1RAs in high‐density lipoprotein cholesterol. GLP‐1RAs did not significantly increase the incidence of adverse events, but Orforglipron and Taspoglutide significantly increased the incidence of gastrointestinal adverse events compared with placebo.

Conclusion:

This study compared the cardiovascular benefits of different GLP‐1RAs, including reductions in cardiovascular events and improvements in multiple cardiovascular risk factors. However, due to limitations in the quantity and quality of the included studies, the conclusions should be interpreted with caution. Future large‐scale, high‐quality clinical trials are needed to validate these findings and further optimize comprehensive cardiovascular management strategies for patients.

2025-01-07·Cureus Journal of Medical Science

Efficacy and Safety of Efpeglenatide in Patients With Type 2 Diabetes and Obesity: A Systematic Review

Review

作者: Narayan, Neha ; Vadde, Tejaswi ; Divity, Shravani ; Tagaev, Tugolbai ; Sandesara, Maharshikumar ; Mamytova, Aiturgan

Efpeglenatide, a novel long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA), shows promise for the treatment of type 2 diabetes mellitus (T2DM) and obesity. This systematic review evaluated the efficacy and safety of efpeglenatide in patients with T2DM and obesity. Literature searches in PubMed, Scopus, and Web of Science focused on randomized controlled trials (RCTs), cohort studies, case-control studies, and longitudinal observational studies from 2019 to 2024. Eight studies met the inclusion criteria. The findings of these studies consistently indicate that efpeglenatide significantly reduces hemoglobin A1C (HbA1C), fasting plasma glucose (FPG), and body weight in patients with T2DM and obesity. Once-weekly dosing offers a convenient alternative to daily GLP-1 RAs and potentially improves adherence. Efpeglenatide also provides cardiovascular and renal benefits, particularly for high-risk patients, thus providing a comprehensive treatment option. The safety profile is similar to that of other GLP-1 RAs, with mild-to-moderate gastrointestinal side effects being the most common and a low risk of hypoglycemia, especially in patients not using insulin or sulfonylureas. Most studies show a low risk of bias and enhanced reliability. However, limitations include the need for long-term safety data and variations in study design. Future research should focus on cardiovascular outcomes, long-term safety, and improvements in quality of life to fully assess the benefits of efpeglenatide. In conclusion, efpeglenatide is a promising treatment for T2DM and obesity, offering effective glycemic control, weight reduction, cardiovascular and renal benefits, a favorable safety profile, and convenient dosing.

项与 Efpeglenatide 相关的新闻（医药）

2025-04-13

·医学新视点

糖尿病患者心肾风险降低多达58%！三联疗法或为临床治疗新选择

▎药明康德内容团队编辑胰高血糖素样肽-1受体激动剂（GLP-1RA）已被证实具有很大治疗潜力，包括降糖、减重，以及降低重大心血管不良事件风险和改善糖尿病患者肾脏预后。近期研究证据显示，GLP-1RA或有益于改善射血分数保留型心力衰竭（HFpEF）的患者的肾脏结局。部分大型临床试验亚组分析结果表明，GLP-1RA和钠-葡萄糖共转运蛋白2抑制剂（SGLT-2i）联合治疗，可减少糖尿病患者心力衰竭住院和肾脏疾病复合事件发生率。在此基础上加用非甾体盐皮质激素受体拮抗剂（MRA）非奈利酮，可能进一步强化心肾保护作用，相关研究结果显示，三联治疗预估可将心血管不良事件风险和慢性肾病进展风险分别降低35%和58%。但GLP-1RA+SGLT-2i+非奈利酮三联疗法的临床效益及适用人群仍需更多研究验证。GLP-1RA可降低糖尿病患者主要不良心血管事件发生风险和肾脏不良结局风险糖尿病是心血管疾病和慢性肾病最重要的危险因素之一。相比于无糖尿病患者，糖尿病患者罹患动脉粥样硬化性心血管疾病的风险高出2~4倍。慢性肾病是糖尿病的主要微血管并发症，会增加心血管疾病和死亡的风险。控制血糖水平有助于预防慢性肾病微血管并发症和心血管事件的发生。对于糖尿病合并心血管疾病或存在多种心血管和肾脏风险的患者，GLP-1RA是治疗可选择用药之一。LEADER试验纳入了2型糖尿病合并心血管高风险的患者9340例，研究人员将患者随机分配接受利拉鲁肽或安慰剂治疗。研究结果显示，平均随访3.8年，相比于安慰剂组，利拉鲁肽组患者的主要不良心血管事件（心血管死亡、非致死性心肌梗死或非致死性卒中的复合终点）减少了13%（HR=0.87）。SUSTAIN-6试验则显示，在2型糖尿病合并心血管高风险患者中，相比于安慰剂组，司美格鲁肽组（皮下注射，每周0.5 mg或1 mg）心血管不良事件风险降低26%（HR=0.74），卒中风险降低了26%。后续Harmony Outcomes、REWIND、AMPLITUDE-O等研究也证实了GLP-1RA在降低2型糖尿病合并心血管高风险患者心血管不良事件、心肌梗死和卒中风险方面的作用。GLP-1RA不仅具有降糖的作用，也具有减重效应。SELECT试验在肥胖[体重指数（BMI）≥27 kg/m2]合并心血管疾病但无糖尿病的患者中开展，探索使用GLP-1RA对于预防心血管事件发生的作用。研究结果显示，在平均3.3年的观察期内，相比于安慰剂，皮下注射司美格鲁肽可使患者体重较基线降低9.39%、心血管不良事件风险降低20%（HR=0.80），尤其是心肌梗死风险降低28%（HR=0.72）。该研究结果提示，GLP-1RA心血管保护作用与减重相关，而非降糖作用。荟萃分析结果表明，GLP-1RA可将糖尿病合并心血管高风险患者的心力衰竭住院率降低约10%。但关于GLP-1RA降低心力衰竭住院风险的研究结果并不完全一致。FIGHT试验纳入因急性心力衰竭住院的射血分数降低的心力衰竭患者300例。所有患者中位左心室射血分数为25%；82%患有缺血性心脏病、59%患有2型糖尿病。结果显示，利拉鲁肽组与安慰剂组死亡（HR=1.10）和心力衰竭再住院（HR=1.30）风险无显著差异，不同糖尿病状态亚组分析结果也相似。因此，关于射血分数降低的心力衰竭患者能否从GLP-1RA用药中获益，仍有待更多证据进行验证。GLP-1RA改善肾脏结局获益的证据多来源于次要结局或探索性分析，其机制可能与大量蛋白尿进展抑制有关，但对其他临床重要肾脏终点的影响尚不明确，包括肾小球滤过率（eGFR）下降速度、开始肾脏替代治疗的时间等。FLOW试验评估皮下注射司美格鲁肽对2型糖尿病患者慢性肾病影响，研究纳入患者3533例，随机接受司美格鲁肽或安慰剂治疗。主要结局为首次肾功能衰竭的时间（持续eGFR<15 ml/min/1.73m2或开始慢性肾脏替代治疗）。研究结果显示，司美格鲁肽组eGFR较基线下降≥50%或因肾脏或心血管原因死亡风险较低（HR=0.76）。肾脏替代治疗的开始时间延迟，但未达到统计学意义（HR=0.84）。因此，司美格鲁肽或可影响2型糖尿病合并慢性肾病患者的临床肾脏终点。GLP-1RA和SGLT-2i的潜在互补证据一项比较GLP-1RA与SGLT-2i疗效的荟萃分析中，纳入5项GLP-1RA相关和3项SGLT-2i相关试验，涉及77242例患者。与安慰剂组相比，GLP-1RA组的心血管不良事件风险降低了12%（HR=0.88），SGLT-2i组的心血管不良事件风险降低了11%（HR=0.89），这表明GLP-1RA和SGLT-2i降低心血管不良事件风险的程度相似。此外，多项荟萃分析结果显示，无论是否患有糖尿病，SGLT2i在射血分数降低的心力衰竭和射血分数保留的心力衰竭中都能将心力衰竭住院降低约30%。GLP-1RA联合SGLT-2i能否进一步降低糖尿病患者的心血管和肾脏事件的发生？理论上来说是可行的，但尚缺乏相关试验来直接验证联合疗法的效果。此前，AMPLITUDE-O试验和Harmony Outcomes试验分别有15.2%（n=618）和6.1%（n=575）的患者在基线时使用SGLT-2i。AMPLITUDE-O试验事后分析发现，基线时SGLT-2i使用者和未使用者的心血管不良事件风险分别降低了30%和26%（HR=0.70和0.74，相互作用P=0.70）、心力衰竭住院风险分别降低了77%和30%（HR=0.23和0.70，相互作用P=0.35）、复合肾脏结局风险分别降低了48%和30%（HR=0.52和0.70，相互作用P=0.38）。Harmony Outcomes试验事后分析未对肾脏结局进行探讨，但也观察到了类似的结果。DECLARE-TIMI 58试验中，4.4%患者基线时使用GLP-1RA，结果显示，SGLT-2i（达格列净）可降低心血管不良事件、心力衰竭住院和复合肾脏结局的风险，这种作用与基线是否使用GLP-1RA无关。从现有研究来看，GLP-1RA和SGLT-2i的作用机制基本上是独立的，但仍需要进一步研究，以评估二者联合治疗是否能够带来更大的临床益处。GLP-1RA+SGLT-2i+非奈利酮的三联治疗策略FIDELIO-DKD、FIGARO-DKD及FIDELITY试验表明，非奈利酮可减少慢性肾病合并糖尿病患者的心血管和肾脏事件发生率，这主要得益于非奈利酮可降低心力衰竭住院风险。这3项大型临床试验的FINE-HEART汇总分析中，非奈利酮降低了心力衰竭住院、白蛋白尿进展复合终点（排除心血管事件影响）、心血管不良事件和全因死亡的风险。参与者中，基线分别有5.8%和8.9%的患者使用GLP-1RA和SGLT-2i，无论这些药物的使用情况如何，非奈利酮对心血管死亡的治疗效果都是一致的。非奈利酮对心血管和肾脏事件的临床益处也不太可能受到GLP-1RA或SGLT-2i联合治疗的影响。但关于非奈利酮联合GLP-1RA和SGLT-2i的附加作用的临床证据仍然有限。有学者将GLP-1RA、SGLT-2i和非奈利酮的相关临床试验数据进行交叉试验分析，以估计三联治疗的效果。研究结果显示，在糖尿病和蛋白尿患者中，相比于常规治疗，三联治疗组的心血管不良事件、心力衰竭住院和慢性肾病进展的风险分别降低了35%（HRs=0.65）、55%（HRs=0.45）和58%（HRs=0.42）。从结果来看，潜在原因是GLP-1RA、SGLT-2i和非甾体MRA的作用机制通常互补和独立、可能部分重叠。因此，这三类药物结合时的效果可能相加。此外，研究还发现，对于50岁以上的患者，相比于单独使用常规疗法，采用三联疗法治疗的患者心血管不良事件、心力衰竭住院和慢性肾病的无事件生存期分别延长了3.2年、3.2年和5.5年。这提示，相比传统疗法或单独用药，GLP-1RA、SGLT-2i和非奈利酮的三联疗法具有更强的心肾保护作用。鉴于现有证据，三联疗法有望提供额外的心脏保护，但需要开展进一步的随机对照试验，以明确三联疗法是否具有相加或协同作用。总结和未来前景联合用药可能进一步增强治疗效果，根据患者情况选择合适药物是未来心血管-肾脏代谢综合征领域的精准治疗方向。2型糖尿病和/或肥胖患者可能受益于联合用药，并改善心血管和肾脏结局。GLP-1RA+SGLT-2i+非奈利酮的方案，可能在心血管和肾脏保护方面具有互补作用。但治疗策略的制定仍需考虑到以下几方面的差异：1）明确从联合治疗中获益的人群；2）明确加强治疗的理想时机和优先级，因为目前的证据不足以弥补这一空白；3）患者接受联合治疗如何维持长期依从性和安全性。本文作者：泰达国际心血管病医院郑刚推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料（可上下滑动查看）[1] Wong ND, Sattar N. Cardiovascular risk in diabetes mellitus: epidemiology, assessment and prevention. Nat Rev Cardiol. 2023;20(10):685–95. [2] Vaduganathan M, Mensah GA, Turco JV, et al. The global burden of cardiovascular diseases and risk: a compass for future health. J Am Coll Cardiol. 2022;80(25):2361–71. [3] Cea Soriano L, Johansson S, Stefansson B, et al. Cardiovascular events and all-cause mortality in a cohort of 57,946 patients with type 2 diabetes: associations with renal function and cardiovascular risk factors. Cardiovasc Diabetol. 2015;14:38. [4] de Boer IH, Khunti K, Sadusky T, et al. Diabetes management in chronic kidney disease: a consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO). Diabetes Care. 2022;45(12):3075–90. [5] American Diabetes Association Professional Practice C: 11. Chronic kidney disease and risk management: standards of care in diabetes-2024. Diabetes Care 2024, 47(Suppl 1):S219-S230. [6] Bornfeldt KE. Does elevated glucose promote atherosclerosis? Pros and Cons Circ Res. 2016;119(2):190–3. [7] Gaede P, Vedel P, Larsen N, et al. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348(5):383–93. [8] Ueki K, Sasako T, Okazaki Y, et al. Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial. Lancet Diabetes Endo crinol. 2017;5(12):951–64. [9] Gaede P, Lund-Andersen H, Parving HH, et al. Effect of a mul tifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580–91. [10] Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Associa tion (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753–86. [11] Agarwal R, Filippatos G, Pitt B, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43(6):474–84. [12] Bjorkegren JLM, Lusis AJ. Atherosclerosis: recent developments. Cell. 2022;185(10):1630–45. [13] Abel ED, Gloyn AL, Evans-Molina C, et al. Diabetes mellitus-progress and opportunities in the evolving epidemic. Cell. 2024;187(15):3789–820. [14] Ritchie RH, Abel ED. Basic mechanisms of diabetic heart disease. Circ Res. 2020;126(11):1501–25. [15] van Raalte DH, Bjornstad P, Cherney DZI, et al. Combination therapy for kidney disease in people with diabetes mellitus. Nat Rev Nephrol. 2024;20(7):433–46. [16] Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–22. [17] Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular out comes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834–44. [18] Hernandez AF, Green JB, Janmohamed S, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-con trolled trial. Lancet. 2018;392(10157):1519–29. [19] Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo controlled trial. Lancet. 2019;394(10193):121–30. [20] Gerstein HC, Sattar N, Rosenstock J, et al. Cardiovascular and renal outcomes with efpeglenatide in type 2 diabetes. N Engl J Med. 2021;385(10):896–907. [21] Ussher JR, Drucker DJ. Glucagon-like peptide 1 receptor agonists: cardiovas cular benefits and mechanisms of action. Nat Rev Cardiol. 2023;20(7):463–74. [22] Giugliano D, Scappaticcio L, Longo M, et al. GLP-1 receptor agonists and cardiorenal outcomes in type 2 diabetes: an updated meta-analysis of eight CVOTs. Cardiovasc Diabetol. 2021;20(1):189. [23] Sattar N, Lee MMY, Kristensen SL, et al. Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of randomised trials. Lancet Diabetes Endocrinol. 2021;9(10):653–62. [24] Pfeffer MA, Claggett B, Diaz R, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015;373(23):2247–57. [25] Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389(24):2221–32. [26] Sawami K, Tanaka A, Node K. Anti-obesity therapy for cardiovascular disease prevention: potential expected roles of glucagon-like peptide-1 receptor agonists. Cardiovasc Diabetol. 2022;21(1):176. [27] Margulies KB, Hernandez AF, Redfield MM, et al. Effects of liraglutide on clinical stability among patients with advanced heart failure and reduced ejection fraction: a randomized clinical trial. JAMA. 2016;316(5):500–8. [28] Jorsal A, Kistorp C, Holmager P, et al. Effect of liraglutide, a glucagon like peptide-1 analogue, on left ventricular function in stable chronic heart failure patients with and without diabetes (LIVE)-a multicentre, double-blind, randomised, placebo-controlled trial. Eur J Heart Fail. 2017;19(1):69–77. [29] Kosiborod MN, Abildstrom SZ, Borlaug BA, et al. Semaglutide in patients with heart failure with preserved ejection fraction and obesity. N Engl J Med. 2023;389(12):1069–84. [30] Kosiborod MN, Petrie MC, Borlaug BA, et al. Semaglutide in patients with obesity-related heart failure and type 2 diabetes. N Engl J Med. 2024;390(15):1394–407. [31] Perkovic V, Tuttle KR, Rossing P, et al. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. N Engl J Med. 2024;391(2):109–21. [32] Kosiborod MN, Deanfield J, Pratley R, et al. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024;404(10456):949–61. [33] Petrie MC, Borlaug BA, Butler J, et al. Semaglutide and NT-proBNP in obesity-related HFpEF. J Am Coll Cardiol. 2024;84(1):27–40. [34] Verma S, Petrie MC, Borlaug BA, et al. Inflammation in obesity-related HFpEF: The STEP-HFpEF Program. J Am Coll Cardiol. 2024;84(17):1646–62.免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。分享，点赞，在看，传递医学新知

临床结果临床成功

2024-11-06

·PipelineReview

Hanmi Unveils Novel Obesity Drug 'HM17321' : A Game-Changer in Overcoming GLP-1-Associated Muscle Loss

Fat Loss Augmentation + Lean Mass Increase Hanmi Presents Three Breakthrough Findings on Novel Obesity Drugs at 2024 ObesityWeek High Quality Obesity Management by Targeting the CRF2 Receptor: Enhanced Fat Loss with Lean Mass Increase Improved Weight Loss and Muscle Preservation with HM15275 Combination Therapy SEOUL, South Korea I November 6, 2024 I Hanmi Pharm. Co., Ltd. has announced promising research results for its novel obesity treatment, HM17321. This groundbreaking drug not only augments fat loss but also significantly increases lean muscle mass, marking it as a potential game-changer in obesity management. HM17321 addresses a key limitation in current GLP-1-based therapies, which often lead to muscle loss as a side effect of significant weight reduction. “HM17321 is the novel concept of obesity drug developed combining advanced artificial intelligence and structural modeling technology with Hanmi’s innovative R&D expertise,” said Dr. In Young Choi, Head of Hanmi’s R&D Center. “It selectively reduces fat while increasing muscle, establishing a new paradigm for high quality obesity treatment. The drug shows significant promise as both monotherapy and combination therapy to improve weight loss potency and quality,” he added. As a peptide-based therapy, HM17321 is anticipated to provide a more cost-effective alternative to antibody-based muscle-preserving drugs, such as myostatin-targeting monoclonal antibodies (mAbs), while also demonstrating enhanced compatibility with incretin-based obesity treatments. Hanmi unveiled its latest findings at 2024 ObesityWeek, an annual obesity-focused conference held in San Antonio, Texas, from November 3 to 6. Hanmi presented two preclinical studies in poster format, underscoring HM17321’s double-action(fat loss and lean muscle gain) benefits and a development strategy that highlights both quantitative and qualitative improvements in weight loss. Unlike conventional incretin-based drugs, HM17321 targets the CRF2 (Corticotropin-Releasing Factor 2) receptor to selectively reduce fat while enhancing muscle mass. This unique approach sets it apart from existing therapies. Current GLP-1-based obesity medications are effective in achieving 15-20% weight loss, but up to 40% of this loss can come from muscle, accompanied by a reduction in basal metabolic rate and a high risk of rapid weight regain (the “yo-yo” effect) after discontinuation. Hanmi reported at the conference that, in animal models, HM17321 achieved weight loss levels comparable to semaglutide, a prominent GLP-1-based therapy, but with the added benefit of increased lean body and muscle mass. This capability makes HM17321 a first-in-class drug, providing a differentiated strategy to high quality weight management by focusing on both fat loss and muscle enhancement simultaneously. In addition to HM17321, Hanmi presented a separate study on the combined use of HM17321 with HM15275, a next-generation anti-obesity drug (LA-GLP/GIP/GCG), and semaglutide. The combination therapy demonstrated a substantial reduction in body weight and fat mass compared to monotherapies, effectively preventing the muscle loss that accompanies significant weight loss treatments. These findings underscore HM17321’s role in improving the quality of weight loss by reducing fat, increasing muscle mass, and enhancing muscle function, making it advantageous in both monotherapy and combination therapies. Hanmi also presented follow-up nonclinical data on HM15275(LA-GLP-1/GIP/GCG), previously unveiled at the American Diabetes Association (ADA) conference. This novel anti-obesity candidate not only demonstrates potential for over 25% weight loss with minimal muscle loss but also offers therapeutic benefits for metabolic diseases. At 2024 ObesityWeek, Hanmi highlighted HM15275’s mechanism of action, which facilitates favorable metabolic phenotype change and enhances energy metabolism alongside dietary control. These effects clearly highlight how HM15275 could distinguish itself from current incretin-based obesity drugs, which primarily rely on appetite suppression. HM15275 is currently in Phase 1 clinical trials in the United States, with plans to progress to Phase 2 trials by 2025, positioning it as a ‘best-in-class’ candidate in obesity treatment. Reflecting on these innovative R&D achievements, Dr. Choi stated, “This year, Hanmi has fortified its leadership in obesity treatment through the unveiling of HM17321 and HM15275. These innovations continue the momentum started by efpeglenatide within our H.O.P project. Our commitment to pioneering R&D will drive unprecedented advancements in obesity treatment, addressing challenges once thought insurmountable.” Official Website: www.hanmipharm.com SOURCE: Hanmi Pharmaceutical

临床1期临床结果

2024-11-06

·PRNewswire

Hanmi Unveils Novel Obesity Drug 'HM17321' : A Game-Changer in Overcoming GLP-1-Associated Muscle Loss

Fat Loss Augmentation + Lean Mass Increase Hanmi Presents Three Breakthrough Findings on Novel Obesity Drugs at 2024 ObesityWeek High Quality Obesity Management by Targeting the CRF2 Receptor: Enhanced Fat Loss with Lean Mass Increase Improved Weight Loss and Muscle Preservation with HM15275 Combination Therapy SEOUL, South Korea, Nov. 6, 2024 /PRNewswire/ -- Hanmi Pharm. Co., Ltd. has announced promising research results for its novel obesity treatment, HM17321. This groundbreaking drug not only augments fat loss but also significantly increases lean muscle mass, marking it as a potential game-changer in obesity management. HM17321 addresses a key limitation in current GLP-1-based therapies, which often lead to muscle loss as a side effect of significant weight reduction. "HM17321 is the novel concept of obesity drug developed combining advanced artificial intelligence and structural modeling technology with Hanmi's innovative R&D expertise," said Dr. In Young Choi, Head of Hanmi's R&D Center. "It selectively reduces fat while increasing muscle, establishing a new paradigm for high quality obesity treatment. The drug shows significant promise as both monotherapy and combination therapy to improve weight loss potency and quality," he added. As a peptide-based therapy, HM17321 is anticipated to provide a more cost-effective alternative to antibody-based muscle-preserving drugs, such as myostatin-targeting monoclonal antibodies (mAbs), while also demonstrating enhanced compatibility with incretin-based obesity treatments. Hanmi unveiled its latest findings at 2024 ObesityWeek, an annual obesity-focused conference held in San Antonio, Texas, from November 3 to 6. Hanmi presented two preclinical studies in poster format, underscoring HM17321's double-action(fat loss and lean muscle gain) benefits and a development strategy that highlights both quantitative and qualitative improvements in weight loss. Unlike conventional incretin-based drugs, HM17321 targets the CRF2 (Corticotropin-Releasing Factor 2) receptor to selectively reduce fat while enhancing muscle mass. This unique approach sets it apart from existing therapies. Current GLP-1-based obesity medications are effective in achieving 15-20% weight loss, but up to 40% of this loss can come from muscle, accompanied by a reduction in basal metabolic rate and a high risk of rapid weight regain (the "yo-yo" effect) after discontinuation. Hanmi reported at the conference that, in animal models, HM17321 achieved weight loss levels comparable to semaglutide, a prominent GLP-1-based therapy, but with the added benefit of increased lean body and muscle mass. This capability makes HM17321 a first-in-class drug, providing a differentiated strategy to high quality weight management by focusing on both fat loss and muscle enhancement simultaneously. In addition to HM17321, Hanmi presented a separate study on the combined use of HM17321 with HM15275, a next-generation anti-obesity drug (LA-GLP/GIP/GCG), and semaglutide. The combination therapy demonstrated a substantial reduction in body weight and fat mass compared to monotherapies, effectively preventing the muscle loss that accompanies significant weight loss treatments. These findings underscore HM17321's role in improving the quality of weight loss by reducing fat, increasing muscle mass, and enhancing muscle function, making it advantageous in both monotherapy and combination therapies. Hanmi also presented follow-up nonclinical data on HM15275(LA-GLP-1/GIP/GCG), previously unveiled at the American Diabetes Association (ADA) conference. This novel anti-obesity candidate not only demonstrates potential for over 25% weight loss with minimal muscle loss but also offers therapeutic benefits for metabolic diseases. At 2024 ObesityWeek, Hanmi highlighted HM15275's mechanism of action, which facilitates favorable metabolic phenotype change and enhances energy metabolism alongside dietary control. These effects clearly highlight how HM15275 could distinguish itself from current incretin-based obesity drugs, which primarily rely on appetite suppression. HM15275 is currently in Phase 1 clinical trials in the United States, with plans to progress to Phase 2 trials by 2025, positioning it as a 'best-in-class' candidate in obesity treatment. Reflecting on these innovative R&D achievements, Dr. Choi stated, "This year, Hanmi has fortified its leadership in obesity treatment through the unveiling of HM17321 and HM15275. These innovations continue the momentum started by efpeglenatide within our H.O.P project. Our commitment to pioneering R&D will drive unprecedented advancements in obesity treatment, addressing challenges once thought insurmountable." Official Website: SOURCE Hanmi Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床结果

100 项与 Efpeglenatide 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11947	-	-	DB15650

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肥胖	临床3期	美国	Hanmi Pharmaceutical Co., Ltd.	2024-01-03
2型糖尿病	临床3期	美国	Hanmi Pharmaceutical Co., Ltd.	2017-12-05
2型糖尿病	临床3期	美国	Sanofi	2017-12-05
2型糖尿病	临床3期	德国	Hanmi Pharmaceutical Co., Ltd.	2017-12-05
2型糖尿病	临床3期	德国	Sanofi	2017-12-05
2型糖尿病	临床3期	波兰	Sanofi	2017-12-05
2型糖尿病	临床3期	波兰	Hanmi Pharmaceutical Co., Ltd.	2017-12-05
2型糖尿病	临床3期	乌克兰	Hanmi Pharmaceutical Co., Ltd.	2017-12-05
2型糖尿病	临床3期	乌克兰	Sanofi	2017-12-05
2型糖尿病	临床3期	英国	Sanofi	2017-12-05

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03496298 (AMPLITUDE-O, Pubmed \| Circulation)	临床3期	2型糖尿病	4,076	Placebo	製衊鬱範蓋齋鹽鬱構憲(積獵壓齋壓憲淵衊網窪) = 壓壓醖廠鏇積獵襯願蓋選鹽艱鹽鹽蓋蓋糧鑰積 (鑰齋鑰顧鑰鹹構觸鬱獵 )	-	2023-02-20
				Efpeglenatide 4 mg	製衊鬱範蓋齋鹽鬱構憲(積獵壓齋壓憲淵衊網窪) = 範壓獵艱遞觸獵構膚選選鹽艱鹽鹽蓋蓋糧鑰積 (鑰齋鑰顧鑰鹹構觸鬱獵 )
NCT03353350 (AMPLITUDE-M, Pubmed)	临床3期	2型糖尿病	406	Efpeglenatide 2 mg	範構壓顧製網遞築蓋鏇(餘製顧鹹繭齋簾鹽淵廠) = 憲積糧齋壓壓蓋簾蓋醖鑰襯餘繭觸餘鹽鹹糧獵 (鹽積網積鏇範壓製範鏇 )	积极	2022-06-07
				Efpeglenatide 4 mg	範構壓顧製網遞築蓋鏇(餘製顧鹹繭齋簾鹽淵廠) = 蓋淵網衊積蓋願膚壓願鑰襯餘繭觸餘鹽鹹糧獵 (鹽積網積鏇範壓製範鏇 )
NCT03353350 (AMPLITUDE-M, CTgov)	临床3期	2型糖尿病	406	placebo (Placebo)	觸鏇鬱鏇繭衊願廠餘網(獵積餘製糧願構鹽壓製) = 憲網餘齋網選廠衊鬱艱憲網顧蓋鑰製鏇鏇襯窪 (鑰範淵網觸鑰選範鏇廠, 1.16) 更多	-	2022-01-18
				efpeglenatide (SAR439977) (Efpeglenatide 4 mg)	觸鏇鬱鏇繭衊願廠餘網(獵積餘製糧願構鹽壓製) = 窪淵鑰鹹鬱窪壓鑰壓醖憲網顧蓋鑰製鏇鏇襯窪 (鑰範淵網觸鑰選範鏇廠, 1.01) 更多
NCT03713684 (AMPLITUDE-L, CTgov)	临床3期	2型糖尿病	370	Background therapy (Placebo)	憲顧積願築遞鬱觸簾鑰(鹽衊顧廠觸糧廠繭範網) = 觸鑰廠積鹽遞鏇觸觸簾餘顧願鏇遞築構簾醖膚 (窪餘衊鏇齋鏇壓選構餘, 1.09) 更多	-	2021-12-02
				Background therapy+Efpeglenatide SAR439977 (Efpeglenatide 2 mg)	憲顧積願築遞鬱觸簾鑰(鹽衊顧廠觸糧廠繭範網) = 蓋餘鏇憲遞憲獵遞鹹簾餘顧願鏇遞築構簾醖膚 (窪餘衊鏇齋鏇壓選構餘, 0.95) 更多
NCT03770728 (AMPLITUDE-S, CTgov)	临床3期	2型糖尿病	312	Placebo+Metformin (Placebo)	鹹製窪製製蓋選糧鑰餘(襯襯廠夢繭積製願願鏇) = 窪鏇膚鏇網餘築艱鏇顧鏇獵夢膚製憲餘衊夢蓋 (顧憲夢廠衊膚範鏇鏇憲, 0.92) 更多	-	2021-12-02
				Metformin+Efpeglenatide SAR439977 (Efpeglenatide 2 mg)	鹹製窪製製蓋選糧鑰餘(襯襯廠夢繭積製願願鏇) = 選淵窪鏇蓋鑰鑰鹹憲築鏇獵夢膚製憲餘衊夢蓋 (顧憲夢廠衊膚範鏇鏇憲, 0.88) 更多
NCT03684642 (AMPLITUDE-D, CTgov)	临床3期	2型糖尿病	908	Metformin+Efpeglenatide (Efpeglenatide 4 mg)	廠範鑰夢壓醖選糧繭觸(壓壓積醖餘壓簾選築製) = 構艱簾窪齋夢艱衊繭糧衊積鏇鑰鏇鏇簾範獵憲 (製鹽獵顧築鹽鹹醖繭積, 0.06) 更多	-	2021-11-01
				Metformin+Efpeglenatide (Efpeglenatide 6 mg)	廠範鑰夢壓醖選糧繭觸(壓壓積醖餘壓簾選築製) = 憲願艱範繭襯構艱遞膚衊積鏇鑰鏇鏇簾範獵憲 (製鹽獵顧築鹽鹹醖繭積, 0.06) 更多
NCT03496298 (AMPLITUDE-O, CTgov)	临床3期	2型糖尿病	4,076	Placebo (Placebo)	鏇膚鬱構餘鬱積構觸膚 = 觸構窪獵願網鏇製選遞餘願壓醖獵獵選鑰築構 (鑰膚淵壓淵選繭獵遞鹽, 願糧艱淵遞獵獵選蓋窪 ~ 膚襯淵鏇膚鑰構遞鏇願) 更多	-	2021-10-15
				Efpeglenatide (SAR439977) (Efpeglenatide 4 mg)	壓艱獵衊襯選壓鬱網衊(憲衊廠淵選鑰衊網窪積) = 繭糧廠醖壓繭鏇鏇獵襯襯獵觸鹽顧願鑰鹹襯艱 (觸範選壓繭艱繭製繭衊, 鑰憲衊遞製範壓積餘網 ~ 壓簾窪繭鹹淵築鏇顧衊) 更多
EASD2021	N/A	代谢性疾病	-	Efpeglenatide	衊獵願簾繭製齋獵網艱(鑰獵蓋糧鑰窪夢鹹艱範) = 範淵醖齋網廠蓋構鹽獵鹽鹽積繭糧憲夢蓋選鹽 (選鹽繭網膚築蓋選窪夢 ) 更多	-	2021-09-29
				HM15136	衊獵願簾繭製齋獵網艱(鑰獵蓋糧鑰窪夢鹹艱範) = 顧衊顧壓淵窪淵醖膚夢鹽鹽積繭糧憲夢蓋選鹽 (選鹽繭網膚築蓋選窪夢 ) 更多
NCT03496298 (AMPLITUDE-O, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	2型糖尿病	4,076	efpeglenatide	顧遞繭選衊獵選憲網窪(壓醖選繭積蓋繭糧遞積) = 鬱蓋憲艱鹽壓範憲糧願繭鹹繭膚醖糧繭壓範積 (壓築簾網醖顧窪憲鬱窪 ) 更多	积极	2021-09-02
				Placebo	顧遞繭選衊獵選憲網窪(壓醖選繭積蓋繭糧遞積) = 網鏇鬱網淵願製觸廠觸繭鹹繭膚醖糧繭壓範積 (壓築簾網醖顧窪憲鬱窪 ) 更多
ADA2021	N/A	代谢性疾病	-	Efpeglenatide	餘願鏇選餘廠構觸鹽淵(膚繭襯窪築醖積齋衊蓋) = 齋廠淵衊壓鑰壓觸簾壓鑰憲顧衊艱製範顧願壓 (襯製艱顧遞衊鹹膚願鹽 ) 更多	-	2021-06-01
				Acylated GLP-1/GIP co-agonist	餘願鏇選餘廠構觸鹽淵(膚繭襯窪築醖積齋衊蓋) = 餘遞積廠憲鏇夢襯餘繭鑰憲顧衊艱製範顧願壓 (襯製艱顧遞衊鹹膚願鹽 ) 更多