Delving into the Latest Updates on CVI-LM001 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

PCSK9

Action

inhibitors

Mechanism

PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors)

Therapeutic Areas

Digestive System DisordersEndocrinology and Metabolic Disease

Active Indication

HyperlipidemiasMetabolic dysfunction-associated steatotic liver disease

Inactive Indication

Primary hypercholesterolemiaPrimary Hyperlipidemia

Originator Organization

CVI Pharmaceuticals (Shanghai) Co Ltd

Active Organization

CVI Pharmaceuticals (Shanghai) Co Ltd

Inactive Organization-

Drug Highest PhaseIND Application

First Approval Date-

RegulationSpecial Review Project (China)

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主要目的：在原发性高血脂受试者中初步评估不同剂量组CVI-LM001和安慰剂相比，在12周的治疗后LDL-C 较基线的下降率；初步评估不同剂量组CVI-LM001的安全性和耐受性。次要目的：在原发性高血脂受试者中，初步评估不同剂量组CVI-LM001与安慰剂相比对以下各项因素的影响：治疗第 2、4、8、12 周的 TC、TG、HDL-C、non-HDL-C 、ApoB、ApoA1、Lp(a)、hsCRP、PCSK9较基线变化率；第2、4、8周的LDL-C下降率。

[Translation]

Primary objective: To preliminarily evaluate the reduction rate of LDL-C from baseline after 12 weeks of treatment in subjects with primary hyperlipidemia in different dose groups of CVI-LM001 compared with placebo; to preliminarily evaluate the safety and tolerability of CVI-LM001 in different dose groups. Secondary objective: To preliminarily evaluate the effects of CVI-LM001 in different dose groups compared with placebo on the following factors in subjects with primary hyperlipidemia: the change rate of TC, TG, HDL-C, non-HDL-C, ApoB, ApoA1, Lp(a), hsCRP, PCSK9 from baseline at 2, 4, 8, and 12 weeks of treatment; the reduction rate of LDL-C at 2, 4, and 8 weeks.

Start Date10 Jul 2020

Sponsor / Collaborator

CVI Pharmaceuticals (Shanghai) Co Ltd

CTR20171263

/ CompletedPhase 1

CVI-LM001片在高血脂受试者的多中心、随机、双盲、安慰剂平行对照的安全性和药代动力学试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled safety and pharmacokinetic study of CVI-LM001 tablets in subjects with hyperlipidemia

主要目的：通过随机、双盲、安慰剂平行对照试验，在高血脂受试者中研究接受CVI-LM001 多次给药后的安全性；次要目的：研究高血脂受试者多次给予CVI-LM001 后的药代动力学特征和药物效应，为Ⅱ期临床试验制定试验方案提供依据。

[Translation]

Primary purpose: To study the safety of CVI-LM001 after multiple administrations in subjects with hyperlipidemia through a randomized, double-blind, placebo-controlled parallel trial. Secondary purpose: To study the pharmacokinetic characteristics and drug effects of CVI-LM001 after multiple administrations in subjects with hyperlipidemia, and to provide a basis for formulating the experimental plan for Phase II clinical trials.

Start Date09 Mar 2018

Sponsor / Collaborator

CVI Pharmaceuticals (Shanghai) Co Ltd

CTR20170443

/ CompletedPhase 1

随机、双盲、安慰剂对照观察中国健康受试者连续多次口服CVI-LM001片的安全性、耐受性和药代动力学试验

[Translation] A randomized, double-blind, placebo-controlled study to observe the safety, tolerability and pharmacokinetics of multiple oral administration of CVI-LM001 tablets in healthy Chinese subjects

随机、双盲、安慰剂对照观察中国健康受试者连续多次口服CVI-LM001片的安全性、耐受性和药代动力学试验

[Translation]

A randomized, double-blind, placebo-controlled study to observe the safety, tolerability and pharmacokinetics of multiple oral administration of CVI-LM001 tablets in healthy Chinese subjects

Start Date17 Jul 2017

Sponsor / Collaborator

CVI Pharmaceuticals (Shanghai) Co Ltd

100 Clinical Results associated with CVI-LM001

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100 Translational Medicine associated with CVI-LM001

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100 Patents (Medical) associated with CVI-LM001

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1

Literatures (Medical) associated with CVI-LM001

01 Mar 2025·Atherosclerosis Plus

Emerging oral therapeutic strategies for inhibiting PCSK9

Review

Author: Ferri, Nicola ; Marodin, Giorgia

Pharmacological inhibition of Proprotein Convertase Subtilisin/Kexin 9 (PCSK9) have been firmly established to be an effective approach to reduce low-density lipoprotein (LDL) cholesterol levels and cardiovascular events. Subcutaneous administration of monoclonal antibodies (evolocumab and alirocumab) every 2 or 4 weeks determined a 60 % reduction of LDL cholesterol levels, while the GalNac-siRNA anti PCSK9 (inclisiran) provided an effective lipid lowering activity (-50 %) after an initial subcutaneous dose, repeated after 3 months and followed by a maintenance dose every 6 months. Although these two approaches have the potentiality to bring the majority of patients at high and very-high cardiovascular risk to the appropriate LDL cholesterol targets, their cost and subcutaneous administration represent a strong limitation for their large-scale use. These problems could be overcome by the development of small chemical molecules anti PCSK9 as oral therapy for controlling hypercholesterolemia. In the present review, we summarized the pharmacological properties of oral anti PCSK9 molecules that are currently under clinical development (DC371739, CVI-LM001, and AZD0780), including the mimetic peptides enlicitide decanoate (MK-0616) and NNC0385-0434.

100 Deals associated with CVI-LM001

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperlipidemias	IND Application	United States	CVI Pharmaceuticals (Shanghai) Co Ltd	-
Metabolic dysfunction-associated steatotic liver disease	IND Application	United States	CVI Pharmaceuticals (Shanghai) Co Ltd	-
Primary hypercholesterolemia	Discovery	China	CVI Pharmaceuticals (Shanghai) Co Ltd	10 Jul 2020
Primary Hyperlipidemia	Discovery	China	CVI Pharmaceuticals (Shanghai) Co Ltd	09 Mar 2018