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更新于：2025-01-23

Lipoprotein (a) hyperlipoproteinemia

脂蛋白(a)高脂蛋白血症

更新于：2025-01-23

基本信息

别名

Hyperlipoproteinaemia (a)、Hyperlipoproteinemia (a)、Lipoprotein (a) hyperlipoproteinaemia

+ [2]

简介-

关联

项与脂蛋白(a)高脂蛋白血症相关的药物

Pelacarsen

靶点

Lp(a)

作用机制

脂蛋白（a）抑制剂

在研机构

诺华中国 [+3]

原研机构

Ionis Pharmaceuticals, Inc.

在研适应症

动脉粥样硬化 [+3]

非在研适应症-

最高研发阶段临床3期

首次获批国家/地区-

首次获批日期1800-01-20

Kylo-11

靶点

Lp(a)

作用机制

脂蛋白（a）抑制剂

在研机构

厦门甘宝利生物医药有限公司

原研机构

厦门甘宝利生物医药有限公司

在研适应症

动脉粥样硬化 [+1]

非在研适应症-

最高研发阶段临床1期

首次获批国家/地区-

首次获批日期1800-01-20

SRSD-216

靶点-

作用机制-

在研机构

Sirius Therapeutics Co., Ltd.

原研机构

Sirius Therapeutics Co., Ltd.

在研适应症

脂蛋白(a)高脂蛋白血症 [+1]

非在研适应症-

最高研发阶段临床申请

首次获批国家/地区-

首次获批日期1800-01-20

项与脂蛋白(a)高脂蛋白血症相关的临床试验

CTR20241810

/ Recruiting临床1期

一项评价Kylo-11在中国成年健康受试者中单次给药剂量递增的安全性、耐受性、药代动力学和药效学的I期临床研究

主要研究目的：评估中国健康成年受试者接受Kylo-11单次给药后24周内的安全性、耐受性。次要研究目的：评估中国健康成年受试者接受Kylo-11单次给药后整个研究期间的安全性、耐受性。评估中国健康成年受试者接受Kylo-11单次给药后的药代动力学（PK）特征。评估中国健康成年受试者接受Kylo-11单次给药后的药效动力学（PD）特征。评估中国健康成年受试者接受Kylo-11单次给药后的免疫原性特征。探索性目的：初步探索Kylo-11单次给药后对脂蛋白（a）［Lp(a)］外其他血脂指标的影响。初步鉴定Kylo-11单次给药后的代谢产物。

开始日期2024-05-20

申办/合作机构

厦门甘宝利生物医药有限公司

NCT05900141

/ Recruiting临床3期

A Single Arm, Open Label Extension (OLE), Multicenter Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Patients With Cardiovascular Disease Who Have Successfully Completed the Apheresis Parent Study.

This non-randomized, open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the double-blind parent study (CTQJ230A12302).

开始日期2023-09-29

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT05305664

/ Active, not recruiting临床3期

A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Assessing the Reduction of the Rate of Lipoprotein Apheresis After Treatment With Pelacarsen (TQJ230) Compared to Placebo in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease Undergoing Weekly Lipoprotein Apheresis in Germany

Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly schedule.

开始日期2022-08-19

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与脂蛋白(a)高脂蛋白血症相关的临床结果

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100 项与脂蛋白(a)高脂蛋白血症相关的转化医学

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0 项与脂蛋白(a)高脂蛋白血症相关的专利（医药）

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项与脂蛋白(a)高脂蛋白血症相关的文献（医药）

2024-10-01·Polish Archives of Internal Medicine

The prevalence of hyperlipoproteinemia(a) in outpatient cardiology clinic patients of European ancestry: results from a STAR-Lp(a) cross-sectional study

Article

作者: Babicki, Mateusz ; Burzyńska, Monika ; Banach, Maciej ; Chudzik, Michał ; Jankowski, Piotr

INTRODUCTIONElevated levels of lipoprotein(a) [Lp(a)] are independently associated with an increased risk of cardiovascular disease (CVD).OBJECTIVESWe aimed to evaluate the levels of Lp(a) among patients of European ancestry referred to outpatient cardiology clinics.PATIENTS AND METHODSWe analyzed 2475 consecutive patients referred to 2 outpatient cardiology clinics between March 2022 and January 2024. Individuals with atherosclerotic CVD, heart failure, significant valve disease, and aortic aneurysm were excluded.RESULTSA majority of the study population were women (n = 1724 [69.7%]). The median (interquartile range) age of the participants was 66 (53-73) years. An Lp(a) level greater than or equal to 30 mg/dl (≥75 nmol/l) was recorded in 21.5% and a level greater than or equal to 50 mg/dl (≥125 nmol/l) was recorded in 13.5% of the patients. In univariable analysis, the Lp(a) level was significantly associated with hypertension, sleep apnea, migraine, polycystic ovary syndrome, physical activity level, as well as fasting blood glucose, glycated hemoglobin A1c (HbA1c), low‑density lipoprotein cholesterol (LDL‑C), and non-high‑density lipoprotein cholesterol concentrations. Female sex (β [SE] = 0.06 [0.02]), atrial fibrillation (β [SE] = 0.05 [0.02]), and the levels of HbA1c (β [SE] = 0.14 [0.02]) and LDL‑C (β [SE] = 0.09 [0.02]) were independently related to the level of Lp(a). Atrial fibrillation (odds ratio [OR], 1.8; 95% CI, 1.01-3.19), migraine (OR, 0.51; 95% CI, 0.32-0.83), and hyperlipidemia (OR, 1.56; 95% CI, 1.22-1.99) were related to the Lp(a) level of 30 mg/dl or above (≥75 nmol/l), while female sex (OR, 1.46; 95% CI, 1.10-1.92), hyperlipidemia (OR, 1.49; 95% CI, 1.12-1.97), hypertension (OR, 1.42; 95% CI, 1.1-1.84) and HbA1c concentration (OR, 0.84; 95% CI, 0.72-0.96) were significantly associated with the Lp(a) level greater than or equal to 50 mg/dl (≥125 nmol/l).CONCLUSIONSThe observed prevalence of increased Lp(a) concentration among patients of European ancestry treated at outpatient cardiology clinics was 21.5%. Female sex, hypertension, atrial fibrillation, migraine, and concentrations of LDL‑C and HbA1c were independently related to the level of Lp(a) in this population.

2023-08-01·Clinical Therapeutics

Hyperlipoproteinemia (a) and Phytoestrogen Therapy in Dialysis Patients: A Review

Review

作者: Tabibi, Hadi ; Yari, Zahra

PURPOSEHyperlipoproteinemia (a) is a prevalent complication in dialysis patients, with no valid treatment strategy. The aim of this narrative review was to investigate the clinical significance of hyperlipoproteinemia (a) and phytoestrogen therapy in dialysis patients.METHODSA comprehensive literature search of the published data was performed regarding the effects of phytoestrogen therapy on hyperlipoproteinemia (a) in dialysis patients.FINDINGSHyperlipoproteinemia (a) occurs in dialysis patients due to decreased catabolism and increased synthesis of lipoprotein (a) [Lp(a)]. A few clinical trials have studied the effects of phytoestrogens on serum Lp(a). All studies of dialysis patients or nonuremic individuals with hyperlipoproteinemia (a), except one, showed that phytoestrogens could significantly reduce serum Lp(a) levels. However, all investigations of phytoestrogen therapy in individuals with normal serum Lp(a) levels showed that it had no effect on serum Lp(a). Phytoestrogens seem to have effects similar to those of estrogen in lowering Lp(a) concentrations.IMPLICATIONSConsidering the high prevalence of hyperlipoproteinemia (a) in dialysis patients, phytoestrogen therapy is a reasonable approach for reducing serum Lp(a) levels and its complications in these patients.

1997-05-01·No to shinkei = Brain and nerve

[Juvenile cerebral infarction with familial hyperlipoproteinemia (a)--case report].

Article

作者: Morita, Y ; Sameshima, T ; Ageta, M ; Taguchi, T

A 34-year-old male with a history of angina pectoris suddenly developed weakness in the right upper and lower limbs, and consulted our hospital. Computed tomography (CT) and magnetic resonance imaging (MRI) suggested cerebral infarction. Cerebral angiography revealed stenosis at the M1 portion of the left middle cerebral artery. Hypertension, diabetes, tobacco or hyperlipidemia were not considered as risk factors for cerebral infarction. The lipoprotein (a) [Lp(a)] level was high. In the present case, medication with a nicotinic acid agent, niceritrol, for hyperlipoproteinemia and low density lipoprotein (LDL) apheresis were performed. Concerning family history, the patient's mother and younger sister had hyperlipoproteinemia. Recent studies have reported that increased Lp(a) levels are an independent risk factor even in cerebral infarction and coronary artery disease. Measurement of Lp(a) levels and treatment for increased Lp (a) levels may be important.

项与脂蛋白(a)高脂蛋白血症相关的新闻（医药）

2024-12-31

·靖因药业

靖因药业又一款siRNA疗法临床试验申报获中国药监局受理

NEWS TODAY 2024年12月31日，中国上海和美国圣地亚哥：靖因药业（上海）有限公司（简称“靖因药业”），今日宣布其递交的SRSD216临床试验申请（IND）成功获得中国国家药品监督管理局药品审核中心（CDE）的受理。SRSD216是一种用于治疗高脂蛋白血症(a)的新一代siRNA疗法。 “本次递交标志着靖因创新siRNA疗法开发的一个重要里程碑。脂蛋白(a)水平升高与动脉粥样硬化性心血管疾病之间的关联已获得大量遗传学和流行病学研究的支持。临床前数据表明，SRSD216具有出色且持久的药效学特征和良好的安全性，有望为预防心血管疾病提供新的解决方案。我们将全力推进这一前景广阔的疗法的临床开发。”靖因药业首席医疗官于沛川博士表示。 “我们很高兴在SRSD216的开发中达到这一关键步骤。”靖因药业首席执行官冀群升博士表示，“这是我们团队共同努力的成果，也是靖因致力于开发创新心血管代谢疾病疗法的全面布局迈出的又一重要一步。” 01 关于ASCVD与高脂蛋白(a)血症动脉粥样硬化性心血管疾病（ASCVD）是全球最常见的死亡原因。血脂异常被认为是 ASCVD 发展的关键因素。尽管低密度脂蛋白胆固醇（LDL-C）一直被视为主要的血脂指标和ASCVD的干预目标，但众多研究表明，脂蛋白(a) [Lp(a)] 是ASCVD的独立危险因素，且不受年龄、饮食或运动的影响。目前用于降脂的药物对Lp(a)的降低作用有限。因此，临床上对直接靶向Lp(a)的药物有着巨大的未满足需求。 02 关于SRSD216注射液 SRSD216注射液是一款新型的双链小干扰核糖核酸（siRNA）。它特异性调节LPA基因，减少肝脏Apo(a)的产生并降低循环中的Lp(a)水平。临床前体内研究表明，单次给药后，Lp(a)水平降低几乎100%，且效果持续超6个月，未观察到任何有意义的安全事件。 03 关于靖因药业靖因药业 (Sirius Therapeutics) 是一家临床阶段的生物技术公司，以人类健康福祉为使命，聚焦新一代核酸创新疗法在心血管代谢疾病领域的全球开发，致力成为颠覆慢病防治的领军者。公司目前已进入临床开发阶段的产品包括用于治疗血栓栓塞性疾病的SRSD107和用于治疗血脂异常的SRSD101。成立于2021年，由国际卓越的管理团队和全球知名医疗健康投资机构孵化。公司采取国际化的战略定位，汇聚中美两地在小核酸疗法领域的人才和资源的优势，建立了以美国为源头创新中心和以中国为全球转化医学中心的布局。利用其小核酸药物研发核心技术平台，开发了多个具有同类首创或同类最佳潜质的差异化全球竞争优势的产品管线。公司已累计获得奥博资本、泓元资本、汉康资本和康禧投资的近1亿美元融资。

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