Individual and Combined Endothelin Receptor and SGLT1/2 Antagonism in Adults With Type 1 Diabetes Mellitus and Chronic Kidney Disease: a Phase 2, Multicenter, Open-label Randomized Cross-over Trial

The aim of this study is to test the hypothesis that sotagliflozin (SGLT1/2 inhibitor) and ambrisentan (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.

开始日期2025-09-01

申办/合作机构

University Medical Center Groningen

[+2]

NCT06933056

/ Not yet recruiting早期临床1期IIT

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

开始日期2025-06-01

申办/合作机构

University of Michigan

[+1]

NCT06618976

/ Recruiting临床4期IIT

SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.

开始日期2025-02-25

申办/合作机构

Icahn School of Medicine at Mount Sinai

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100 项与索格列净相关的专利（医药）

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328

项与索格列净相关的文献（医药）

2025-06-01·DIABETES RESEARCH AND CLINICAL PRACTICE

Comparative efficacy and safety of SGLT2 inhibitor class members in patients with heart failure and type 2 diabetes: A systematic review and network meta-analysis of randomized controlled trials

Review

作者: Su, Angela Y ; Valenzuela, German V ; Pasupuleti, Vinay ; Hernandez, Adrian V ; Csere, Molly M ; Shan, Ryan

We conducted a systematic review with pairwise (PMA) and network meta-analyses (NMA) to evaluate sodium-glucose transport protein 2 inhibitor (SGLT2i) effects in patients with both heart failure (HF) and type 2 diabetes mellitus (T2DM). Five databases were searched up to April 15, 2025. Primary outcomes were all-cause mortality (ACM), cardiovascular death (CVD), all-cause hospitalization (ACH), and hospitalization for heart failure (HHF). SGLT2i class effects versus control were assessed via PMA and individual SGLT2i comparative efficacy via NMA plus ranking using p-scores. Seventeen randomized controlled trials (n = 17,809) were included. Arms included canagliflozin (n = 2), dapagliflozin (n = 6), empagliflozin (n = 6), ertugliflozin (n = 1), ipragliflozin (n = 1), sotagliflozin (n = 1), placebo (n = 13), and standard of care (n = 4). Compared to control, SGLT2i significantly reduced ACM (HR 0.87, 95 %CI 0.78 to 0.98, low quality of evidence [QoE]), ACH (HR 0.74, 95 %CI 0.62 to 0.88, high QoE), and HHF (HR 0.70, 95 %CI 0.63 to 0.77, low QoE); but not CVD (HR 0.87, 95 %CI 0.76 to 1.00, very low QoE). Canagliflozin ranked highest in decreasing ACM (p-score = 0.86), CVD (p-score = 0.82), and HHF (p-score = 0.88). In patients with HF and T2DM, SGLT2i class effects include ACM, ACH, and HHF reduction. Among SGLT2i, canagliflozin showed greatest ACM, CVD, and HHF benefit.

2025-06-01·Biochemistry and Biophysics Reports

Type 2 diabetes mellitus – conventional therapies and future perspectives in innovative treatment

Review

作者: Sroka-Bartnicka, Anna ; Gieroba, Barbara ; Kryska, Adrianna

Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and dysfunction of the pancreatic beta cells, which leads to elevated blood glucose levels. Conventional therapies, including metformin, sulfonylureas, and insulin, have long served as the cornerstone of treatment. However, they often face limitations, such as adverse effects, reduced efficacy over time, and difficulties in achieving optimal glycemic control. This has sparked considerable interest in developing novel and experimental therapeutic strategies to enhance treatment outcomes. Recent advances in diabetes management feature dual incretin receptor agonists, like tirzepatide, which combine GLP-1 and GIP receptor agonism, resulting in increased insulin secretion, decreased glucagon release, and significant weight loss. Additionally, dual SGLT1/2 inhibitors, such as sotagliflozin, show promise for more significant blood glucose reduction and improved weight loss by targeting glucose regulation in both the gut and kidneys. Other promising methods include glucagon receptor antagonists, GPR119 agonists, and FGF21 analogs, which strive to enhance insulin sensitivity and improve glucose metabolism through innovative pathways. Gene editing technologies, including CRISPR-Cas9 and AMPK activators, are also being investigated to tackle the underlying pathophysiology of T2DM more effectively. While these experimental therapies show promise, their long-term safety and efficacy remain under research. This article reviews the conventional therapies currently in use. It investigates future perspectives on innovative treatments for T2DM, emphasizing the potential of these new therapies to transform diabetes care and enhance patient outcomes.

2025-06-01·Drug Research

Therapeutic Potential of Sotagliflozin in Animal Models of Non-alcoholic Fatty Liver Disease with and without Diabetes

Article

作者: Deshmukh, Nitin J. ; Patil, Mohan ; Kalshetti, M. S. ; Nandanwar, Manohar ; Sangle, Ganesh V.

Abstract:

Sotagliflozin, a dual SGLT1/2 inhibitor, enhances glucagon like peptide-1 (GLP-1) levels and GLP-1 receptor agonists are used to manage non-alcoholic fatty liver disease (NAFLD). Study investigates the effects of sotagliflozin on NAFLD, alone and combined with linagliptin, comparing outcomes in normoglycemic and hyperglycemic animal models.Obese fatty liver disease (FLD) model was induced by high-fat diet (HFD) feeding, while a diabetic non-alcoholic steatohepatitis (NASH) model was developed by administering a single dose of streptozotocin to neonatal mice, followed by HFD feeding post-weaning. At termination of the study, parameters including biochemical markers, inflammatory cytokines, hepatic lipid content, and histopathology were assessed.In NASH mice, sotagliflozin and linagliptin reduced hepatic triglycerides by 60% and 44%, respectively, and cholesterol by 46% and 49%. Their combination further decreased triglycerides by 68.5% and cholesterol by 83.9%. In FLD mice, sotagliflozin and linagliptin reduced triglycerides by 33% and 17%, respectively, and cholesterol by 46% and 21%. Combination treatment offered no benefit, reducing triglycerides by 38% and cholesterol by 27%. Both the treatments improved plasma fibroblast growth factor 21, hepatic interlukin-6, glucose tolerance, steatosis and mitigated fat pad weight, but their combination did not show additional benefit. However, combination treatment demonstrated added benefit in modulating NAFLD activity score, liver enzymes, glycogenated hepatic nuclei, plasma glucose and active GLP-1 levels.Study underscores sotagliflozinʼs potential to mitigate NAFLD and highlights the benefit of combining it with linagliptin in hyperglycemic NASH model, which showed limited efficacy in normoglycemic FLD mice.

203

项与索格列净相关的新闻（医药）

2025-05-19

·GlobeNewswire-Health Care

SONATA-HCM Study Design Presented at Heart Failure 2025, the Annual Congress of the Heart Failure Association of the European Society of Cardiology

Lexicon is evaluating the safety and efficacy of sotagliflozin in patients with both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) Pivotal Phase 3 clinical trial is actively enrolling patients in 20 countries, with all sites expected to be operational by Q3 2025 THE WOODLANDS, Texas, May 19, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced details of its “SOtaglifloziN in Patients with SymptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)” study were presented on Saturday, May 17. The study design was disclosed in Belgrade, Serbia at one of the premier international heart failure meetings: Heart Failure 2025, the Annual Congress of the Heart Failure Association of the European Society of Cardiology. Enrollment is underway in SONATA-HCM, with all study sites in 20 countries expected to be operational by September 2025. Lexicon believes there is potential for the study results to support a supplemental new drug application (sNDA) for sotagliflozin for both obstructive and non-obstructive HCM. SONATA-HCM is the only ongoing Phase 3 study in both obstructive and non-obstructive HCM. It is a randomized, double-blind, placebo-controlled multicenter trial that will evaluate the efficacy of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, on symptoms, function, and other patient-reported outcomes, as well as safety in patients with symptomatic HCM. The study is designed to enroll 500 patients worldwide, 250 with obstructive HCM and 250 with non-obstructive HCM. The primary efficacy endpoint is improvement in symptoms, as measured by change from baseline to week 26, in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ) CSS survey. "There is a huge unmet need for people suffering from HCM, with no approved or effective therapies for non-obstructive HCM," said Sharlene M. Day, M.D., co-principal investigator for SONATA-HCM and Presidential Professor and Director of Translational Research in the Division of Cardiovascular Medicine and the Cardiovascular Institute at the University of Pennsylvania Perelman School of Medicine. "I'm very excited to be testing the potential for sotagliflozin to improve symptoms in a broad number of patients across the spectrum of HCM, as has previously been demonstrated in patients with heart failure with reduced and preserved ejection fraction. Sotagliflozin’s tolerability profile and immediate benefits observed in patients with heart failure could potentially make it a very appealing option for patients with HCM if the benefits do indeed extend to this population." As a chronic, progressive disease, HCM can worsen over time and lead to other complications, including heart failure and stroke. Sotagliflozin is a proven drug for the treatment of heart failure, with an established safety record and significant use in clinical practice. A growing body of evidence suggests that sotagliflozin’s dual inhibition of SGLT1 and SGLT2 reduces the risk of major adverse cardiovascular events (MACE), including heart attack and stroke, as most recently published in The Lancet in February 2025. “SONATA-HCM is an important study with the potential to support a broad label to enhance the care of patients with both obstructive and non-obstructive HCM,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. For more information on the study, visit the SONATA-HCM page on ClinicalTrials.gov. About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. About Lexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com. Safe Harbor StatementThis press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Investor and Media Inquiries:Lisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com

临床3期

2025-03-28

·GlobeNewswire-Health Care

Lexicon Pharmaceuticals Announces Exclusive License Agreement with Novo Nordisk for LX9851

Lexicon eligible to receive up to $1 billion in upfront and development, regulatory and sales milestone payments, including $75 million in upfront and near-term milestone paymentsTHE WOODLANDS, Texas, March 28, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development candidate in obesity and associated metabolic disorders. Under the terms of the agreement, Novo Nordisk obtains an exclusive, worldwide license to develop, manufacture and commercialize LX9851 in all indications. Lexicon will be responsible for completing agreed upon Investigational New Drug (IND) application-enabling activities for LX9851. Novo Nordisk will be responsible for filing the IND, all further development, manufacturing and commercialization of LX9851. Lexicon is eligible to receive upfront and near-term milestone payments of up to $75 million. In total, Lexicon will be eligible to receive $1 billion in upfront and potential development, regulatory and sales milestone payments. Lexicon is also entitled to tiered royalties on net sales of LX9851. LX9851, discovered and developed by Lexicon, is a potent and selective oral small molecule inhibitor of Acyl-CoA Synthetase 5 (ACSL5). ACSL5 plays a key role in the metabolic pathway which regulates fat accumulation and energy balance. Additionally, LX9851 may activate the ileal brake mechanism leading to increased satiety by delaying gastric emptying and suppressing appetite. Preclinical in vivo efficacy data presented at Obesity Week 2024 show that LX9851, when combined with semaglutide, significantly reduced weight, food intake and fat mass compared to semaglutide alone. Separately, LX9851 mitigated weight regain and had positive effects on liver steatosis when introduced after semaglutide discontinuation. "We are thrilled that Novo Nordisk, a global leader in diabetes care and obesity management, has recognized the potential of LX9851," said Mike Exton, Ph.D., chief executive officer and director of Lexicon. "This arrangement decisively strengthens our financial position, providing optionality as we further invest and accelerate our R&D portfolio.” “Novo Nordisk is committed to serving the diverse needs of people living with obesity and other metabolic diseases and to build a pipeline of differentiated drug candidates in this space,” Jacob Sten Petersen, Senior Vice President, Diabetes, Obesity and MASH therapeutic area at Novo Nordisk. “We are pleased to enter this agreement with Lexicon as it will allow us to explore a novel biology and potential treatment paradigm further, and we look forward to building on the great work Lexicon has already done with the development of LX9851.” About LX9851LX9851 is an orally delivered small molecule drug candidate for the treatment of obesity and associated cardiometabolic disorders. Lexicon is investigating the pharmacology of LX9851 as a stand-alone therapy and in combination with GLP-1 agonists such as semaglutide. Lexicon scientists identified the function of ACSL5, the target of LX9851, based on their discovery that knockout mice lacking the target enzyme exhibited favorable phenotypes across multiple measures of metabolic syndrome in preclinical models, including resistance to diet-induced obesity and improved body composition. About Lexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in cardiology, neuropathic pain, metabolism and other indications. For additional information, please visit www.lexpharma.com. About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, conduct preclinical and clinical development and obtain necessary regulatory approvals of pilavapadin (LX9211), LX9851, sotagliflozin and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Investor and Media Inquiries:Lisa DeFrancesco Lexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com

引进/卖出

2025-03-11

·医学新视点

专家对话：降脂、降糖、减重等药物，如何改善心血管代谢健康？

高血压、血脂异常和肥胖是现代生活中常见的慢性疾病，它们不仅相互关联，还常常共同导致心血管疾病等严重健康问题。密西根大学Eugene Chen（陈育庆）教授与中南大学湘雅二医院彭道泉教授、上海交通大学附属瑞金医院王继光教授为我们分享了关于心血管代谢疾病的最新研究成果与临床治疗进展，并深入探讨了代谢综合征、心血管疾病的风险管理以及最新药物在血脂、血糖、肥胖等方面的应用。陈育庆教授：代谢与心血管健康密不可分陈育庆教授详细探讨了代谢综合征的概念以及其对心血管健康的影响：代谢综合征是一组与肥胖、糖尿病、高血压等疾病相关的病理状态，通常会导致心血管疾病的高发。尤其在中国，心血管代谢疾病的流行情况严峻，据统计，高血压、糖尿病和肥胖分别影响着2.45亿、1.09亿和1.72亿中国人口，而高血压前期、糖尿病前期和超重人群也呈现出更为严重的增长趋势。胰岛素抵抗被认为是多种心血管危险因素的关键驱动因素，它在肥胖、糖尿病和高血压等疾病的发生和发展中起着核心作用。过氧化物酶体增殖物激活受体γ（PPAR-γ）的激活通过控制脂肪、糖类、能量的代谢在疾病的发生中发挥着核心作用，尤其在肥胖和糖尿病患者中影响显著。1997年首次发现的PPAR-γ激动剂[如曲格列酮（troglitazone）、吡格列酮（pioglitazone）和罗格列酮（rosiglitazone）]都成为研究和治疗这些疾病的重要药物。然而，这些药物也有副不良作用，如可能出现体重增加、水潴留、浮肿及肝毒性等。近年来针对糖尿病及心血管疾病的药物研发不断取得进展，钠-葡萄糖共转运体1/2 (SGLT1/2）抑制剂（如sotagliflozin）因其显著的临床效果和低不良反应，成为了治疗糖尿病及心衰患者的热点药物。多项临床试验证明该药物能够降低心血管死亡率，并且对心脏功能恢复具有积极作用。通过全新的药物治疗方法可以同时改善心血管和代谢健康，这一发现进一步认识了心血管疾病与代谢疾病之间的关系，并为临床治疗提供了新的方向。在胰岛素抵抗、高血压、血脂紊乱与肥胖的综合管理中，药物与生活方式干预的结合尤为重要。通过使用新的药物[如胰高血糖素样肽-1（GLP-1）受体激动剂、SGLT2抑制剂、前蛋白转化酶枯草溶菌素9（PCSK9）抑制剂等]并结合健康饮食和适当的运动，能够更有效地控制血脂、血压和胰岛素抵抗，更有助于提高心血管疾病的预防和治疗效果，改善患者的整体健康状况。陈育庆教授特别提到，良好的生活习惯对于心血管健康至关重要，尤其是在控制代谢性疾病方面。通过遵循“Life’s Essential 8”这一健康生活指南，可以显著改善心血管健康。这包括保持充足的睡眠（每天7~9小时）、健康饮食、定期的中等强度运动（每周150分钟），不吸烟，保持健康体重，控制血压、胆固醇水平以及空腹血糖。王继光教授：高血压分期、分级、分型管理的理论与实践在此次讲座中，王继光教授探讨了高血压的防治与管理，强调了早期干预和个体化治疗的重要性。王继光教授表示，通过精确的血压监测与药物调控，结合生活方式的改善，可以有效降低高血压患者的心血管事件风险。近年来，老龄患者尤其是60岁以上人群的高血压患病率显著上升，从2012年的44.6%增至55.7%。王继光教授指出，高血压的管理应该重视分级、分期和分型。分级诊断根据患者的血压水平，分期根据血压对血管和器官的影响来评估，而分型则结合高血压的病因和病理学特征，为患者提供个体化的治疗方案。其次，动态血压监测推动了智能化高血压诊疗中心的建设，提高了血压测量的准确性，支持了个体化治疗的实施。尤其是家庭血压监测的普及，极大地改善了患者自我管理血压的能力，确保了治疗方案的及时调整。此外，王继光教授还深入分析了高血压与肾脏疾病、阻塞性睡眠呼吸暂停综合征（OSAS）等病症的关系，展示了高血压与其他疾病的共性临床表现，尤其是与肾脏疾病的交叉影响。其团队的研究也涉及到高血压患者合并OSAS的治疗，通过持续气道正压（CPAP）治疗，进一步探讨了如何通过改善睡眠呼吸状况来降低高血压患者的心血管风险，为综合治疗提供了新的视角和依据。随着新型药物的不断涌现，王继光教授展示了药物如baxdrostato和沙库巴曲缬沙坦/阿利沙坦在临床试验中的降压效果，特别是在长期管理高血压中的优势。通过对比不同的药物治疗方案，王继光教授强调，当前降压治疗所取得的巨大进步及其潜在的广阔前景。这些新型药物不仅为高血压的治疗提供了更多选择，还可能改善患者的长期预后。通过逐步提高治疗率和达标率，高血压的控制率有望达到50%，这一目标的实现，将为中国心血管疾病的防治奠定坚实的基础。彭道泉教授：血脂剩余风险治疗进展在本次讲座中，彭道泉教授深入探讨了血脂剩余风险的识别与治疗策略，重点介绍如何利用最新的药物和治疗方法进一步减少动脉粥样硬化性心血管疾病（ASCVD）风险。彭道泉教授指出，尽管常规降脂治疗可以有效降低低密度脂蛋白胆固醇（LDL-C），但仍有部分患者存在血脂剩余风险，表现为甘油三酯（TG）、高密度脂蛋白（HDL）及其他脂质异常。为此，他强调了分层治疗的重要性，通过评估LDL-C、TG、脂蛋白（a）等指标，判断是否需要使用新型药物，如PCSK9抑制剂，这种精准的治疗方法有助于更有效地管理血脂异常。接着，彭道泉教授详细介绍了bempedoic酸的作用机制。Bempedoic酸可以通过抑制肝脏的ATP柠檬酸裂解酶（ACL）降低胆固醇合成，从而显著降低LDL-C水平。研究显示，bempedoic酸在临床应用中效果显著，尤其是在60个月的追踪中，LDL-C水平持续降低，心血管事件的发生率也有所减少。另外，bempedoic酸对心血管事件的预防同样有效果，特别是在不耐受他汀类药物的患者中，这些研究结果为bempedoic酸的临床应用提供了重要依据。近几年涌现的几种新型药物，如zodasiran和plozasiran，在临床试验中也表现出了良好的疗效。Zodasiran通过RNA干扰降低TG，最大降低幅度为63%，非高密度脂蛋白胆固醇（non-HDL-C）也减少了36%，载脂蛋白B（ApoB）下降了22%。Plozasiran则在24周的研究中显著减少了TG（62.4%）及ApoB（20%）。这些结果表明，这些新药在治疗高脂血症方面具有巨大的潜力。此外，还有ApoCIII抑制剂可以通过降低TG及apoB水平，在改善相关脂质代谢紊乱中表现出积极的作用，为患者提供了进一步的治疗选项。在治疗过程中，患者的脂质水平变化明显，且未见显著副作用。随着新药的不断推出，siRNA技术也开始在脂质代谢领域展现其强大的潜力。通过干扰特定的基因表达，这些小分子药物能够直接影响脂质的合成与代谢，为高脂血症的治疗提供了新的方向，尤其是在提高高密度脂蛋白（HDL）功能方面表现突出。总的来说，这些新型降脂药物的出现，为高脂血症患者提供了更多的治疗选择，且具有显著的疗效和良好的安全性。这些药物不仅能有效降低血脂，还能进一步降低心血管疾病的风险，为患者带来更好的生活质量。随着研究的深入，未来这些药物的临床应用将更加广泛，进一步推动心血管疾病治疗的进步。相关阅读 3年持续降脂，预防心血管疾病！JAMA子刊：无需高强度他汀，替代方案安全有效降脂至少80%，1年多内持续降低！JAMA：RNAi疗法为心血管疾病患者带来新希望预防心血管疾病，健康老年人停用阿司匹林安全吗？重磅研究带来启示中国人群新证据：无论高血压病史长短，达到<130 mmHg就能降低心血管疾病风险！挑战认知？没接受治疗，42%患者血压恢复正常，心血管疾病风险还降低34%！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]Saklayen MG. The Global Epidemic of the Metabolic Syndrome. Curr Hypertens Rep. 2018;20(2):12. Published 2018 Feb 26. doi:10.1007/s11906-018-0812-z [2]国家心血管病中心阜外医院鲁向锋教授 [3]Li Y, Zhou D, Ren Y, et al. Mir223 restrains autophagy and promotes CNS inflammation by targeting ATG16L1. Autophagy. 2019;15(3):478-492. doi:10.1080/15548627.2018.1522467 [4]Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes [published correction appears in N Engl J Med. 2007 Jul 5;357(1):100.]. N Engl J Med. 2007;356(24):2457-2471. doi:10.1056/NEJMoa072761 [5]王继光.内科理论与实践.2014;9(6):365-368. [6]王继光.高血压数字平台与数字疗法.临床心血管病杂志,2022;38(8):606-609. [7]Wang JG. Annals of Translational Medicine 2018; 6(15):296. [8]Writing Committee, Lloyd-Jones DM, Morris PB, et al. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee [published correction appears in J Am Coll Cardiol. 2023 Jan 3;81(1):104. doi: 10.1016/j.jacc.2022.11.016.]. J Am Coll Cardiol. 2022;80(14):1366-1418. doi:10.1016/j.jacc.2022.07.006 [9]Terlizzi M, Bossi A. ProtecT trial: What's new after 15 years of follow-up: Re: Hamdy FC and colleagues; N Engl J Med. 2023 Apr 27. Urologia. 2024;91(1):3-4. doi:10.1177/03915603231225604 [10]Teo YH, Chia AZQ, Teo YN, et al. The impact of sodium-glucose cotransporter inhibitors on blood pressure: a meta-analysis and metaregression of 111 randomized-controlled trials. J Hypertens. 2022;40(12):2353-2372. doi:10.1097/HJH.0000000000003280 [11]Stroes ESG, Alexander VJ, Karwatowska-Prokopczuk E, et al. Olezarsen, Acute Pancreatitis, and Familial Chylomicronemia Syndrome. N Engl J Med. 2024;390(19):1781-1792. doi:10.1056/NEJMoa2400201 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

100 项与索格列净相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10669	索格列净	A10BK06	DB12713

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
心脏衰竭	美国	Lexicon Pharmaceuticals, Inc.	2023-05-26
1型糖尿病	欧盟	NCI Healthcare LLC	2019-04-26
1型糖尿病	冰岛	NCI Healthcare LLC	2019-04-26
1型糖尿病	列支敦士登	NCI Healthcare LLC	2019-04-26
1型糖尿病	挪威	NCI Healthcare LLC	2019-04-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性肾病	申请上市	美国	Lexicon Pharmaceuticals, Inc.	2024-06-21
糖尿病肾病	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2024-10-31
糖尿病肾病	临床3期	加拿大	Lexicon Pharmaceuticals, Inc.	2024-10-31
终末期肾脏病	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2024-10-31
终末期肾脏病	临床3期	加拿大	Lexicon Pharmaceuticals, Inc.	2024-10-31
非梗阻性肥厚型心肌病	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2024-09-24
非梗阻性肥厚型心肌病	临床3期	阿根廷	Lexicon Pharmaceuticals, Inc.	2024-09-24
非梗阻性肥厚型心肌病	临床3期	比利时	Lexicon Pharmaceuticals, Inc.	2024-09-24
非梗阻性肥厚型心肌病	临床3期	巴西	Lexicon Pharmaceuticals, Inc.	2024-09-24
非梗阻性肥厚型心肌病	临床3期	格鲁吉亚	Lexicon Pharmaceuticals, Inc.	2024-09-24

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03315143 (SCORED, Lancet) 人工标引	临床3期	缺血	10,584	Sotagliflozin	網夢鹽窪壓鑰淵餘鹹願(壓壓構淵蓋醖範窪艱鏇) = 網襯醖觸範鬱積顧製構積網遞製膚製窪壓鑰憲 (醖鹹餘衊獵願蓋憲製廠 ) 更多	积极	2025-02-14
				Placebo	網夢鹽窪壓鑰淵餘鹹願(壓壓構淵蓋醖範窪艱鏇) = 憲繭鬱網鏇選膚廠醖鹹積網遞製膚製窪壓鑰憲 (醖鹹餘衊獵願蓋憲製廠 ) 更多
NCT02531035 \| NCT02384941 \| NCT02421510 (Pubmed) 人工标引	N/A	1型糖尿病 \| 慢性肾病	-	Sotagliflozin 200mg (CKD)	觸鏇衊繭獵積製鑰憲鹽(築鹹顧襯鹹觸範選蓋構) = 鹽蓋構觸選鹽膚積繭鬱艱夢窪簾蓋齋鹹壓願積 (壓醖夢壓艱顧選範顧窪 ) 更多	积极	2024-11-01
				Sotagliflozin 400mg (CKD)	觸鏇衊繭獵積製鑰憲鹽(築鹹顧襯鹹觸範選蓋構) = 願餘蓋醖簾鏇憲蓋膚糧艱夢窪簾蓋齋鹹壓願積 (壓醖夢壓艱顧選範顧窪 ) 更多
NCT03285594 (SOTA-INS, GlobeNewswire) 人工标引	临床3期	2型糖尿病	-	Sotagliflozin 400 mg	憲蓋壓膚膚蓋鏇鹽顧構(餘廠遞憲膚願選簾鑰膚) = 遞構選鬱壓網積餘遞糧遞鏇淵夢鹹餘襯鏇願糧 (鹹築憲窪築鹹獵簾鏇構 )	积极	2024-09-10
				Sotagliflozin 200 mg	憲蓋壓膚膚蓋鏇鹽顧構(餘廠遞憲膚願選簾鑰膚) = 築衊窪醖築簾廠觸鬱獵遞鏇淵夢鹹餘襯鏇願糧 (鹹築憲窪築鹹獵簾鏇構 )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	临床3期	2型糖尿病 \| 心脏衰竭	-	Sotagliflozin	網憲鹹積夢鹽蓋膚製顧(築繭衊膚壓衊膚襯製夢) = The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups 鹹選鏇鏇築積網憲憲醖 (網繭積夢鏇窪觸網鹹鏇 )	积极	2024-09-01
				Placebo
ESC2024	N/A	糖尿病	-	Sotagliflozin	夢蓋鏇繭廠繭齋鏇鏇製(網獵鏇夢網繭繭襯齋繭) = 憲衊壓鹽齋衊選顧鏇醖淵選蓋淵選獵構廠鹽簾 (鹽壓窪醖鏇積蓋築餘範 ) 更多	-	2024-08-30
				Placebo	夢蓋鏇繭廠繭齋鏇鏇製(網獵鏇夢網繭繭襯齋繭) = 糧糧構構鹹構顧鹽鹹衊淵選蓋淵選獵構廠鹽簾 (鹽壓窪醖鏇積蓋築餘範 ) 更多
917-P (ADA2024)	临床3期	2型糖尿病	770	Sotagliflozin 400 mg	衊製餘獵遞憲網獵構窪(簾築繭壓觸鹽鏇窪衊觸) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy 衊廠選觸蓋構醖積構觸 (鏇簾網齋選壓簾齋蓋遞 ) 更多	积极	2024-06-14
				Empagliflozin 25 mg
924-P (ADA2024)	临床3期	2型糖尿病追加	570	Sotagliflozin 400 mg	積觸淵範遞淵衊築衊蓋(鹽顧鹹餘鏇壓積積鹹窪) = 範鏇窪遞顧鏇鏇獵艱鑰範壓醖艱築觸齋窪鬱夢 (鬱鬱願廠蓋襯鹹遞襯糧 )	积极	2024-06-14
				Sotagliflozin 200 mg	積觸淵範遞淵衊築衊蓋(鹽顧鹹餘鏇壓積積鹹窪) = 範選衊願鹽糧艱襯築餘範壓醖艱築觸齋窪鬱夢 (鬱鬱願廠蓋襯鹹遞襯糧 )
NCT03315143 (SCORED, GlobeNewswire) 人工标引	临床3期	心脏衰竭	1,932	INPEFA® (sotagliflozin)	壓選顧艱鹹獵簾艱齋鏇(製網廠齋鬱夢淵鬱膚膚) = 鹽糧窪鏇衊餘築廠膚選顧鹹窪齋遞衊願積鏇糧 (獵遞築築鬱鬱襯遞夢築 )	积极	2024-05-14
SOLOIST-WHF and SCORED (ESC2024)	N/A	obesity \| type 2 diabetes (T2D)	-	Sotagliflozin	醖鏇範製顧鑰齋選簾糧(糧繭壓廠衊蓋獵遞艱鹹) = 網壓鬱選願獵製餘襯鬱獵選鹽鏇襯衊顧簾齋範 (鏇選壓選獵遞選網齋艱 )	积极	2024-05-14
NCT03315143 (SCORED, ACC2024) 人工标引	临床3期	心血管疾病 \| 2型糖尿病 \| 慢性肾病	10,584	Sotagliflozin	鹹壓壓遞鏇構廠範鹽簾(壓網築醖壓蓋構餘憲窪) = 糧壓鬱齋襯衊衊艱衊醖觸艱繭憲膚選遞夢鹹艱 (膚鬱顧顧襯蓋蓋膚鏇醖 ) 更多	积极	2024-03-25
				Placebo	鹹壓壓遞鏇構廠範鹽簾(壓網築醖壓蓋構餘憲窪) = 觸襯鬱觸築憲糧鑰夢製觸艱繭憲膚選遞夢鹹艱 (膚鬱顧顧襯蓋蓋膚鏇醖 ) 更多