更新于：2024-11-01

Lipoprotein (a) hyperlipoproteinemia

脂蛋白(a)高脂蛋白血症

更新于：2024-11-01

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

Novartis Pharma Stein AG [+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

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）

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.