Recently,The official website of the Drug Clinical Trial Registration and Information Disclosure Platform shows, Eli Lilly registered aInElevated Lipoprotein(a) LevelsEvaluation of Muvalaplin Tablets in AdultsMajor Adverse Cardiovascular EventsPhase III clinical trials impacted. Public information shows that this is the initiation of the drug'sThe FirstPhase III.Screenshot source: Clinical Trial Registration and Information Disclosure PlatformThis is aPhase III, randomized, double-blind, placebo-controlled study, aimed atWith elevated lipoprotein(a) levels and a history of atherosclerotic cardiovascular disease（ASCVD）Event or First OccurrenceASCVD Increased Event Risk in Adults Evaluating the Impact of Muvalaplin on Major Adverse Cardiovascular Events.The trial is planned to be conducted inEnrollment in China: 650 people, international enrollment10,450 people. The primary endpoint of the study isEvaluation inReduce MACE-4 Composite EndpointIn terms of risk, whether Muvalaplin is superior to placebo.Muvalaplin(Movaberin, Research Code: LY3473329)）Developed by Eli Lilly and CompanyOnce daily orallyOfLp(a) selective inhibitor, which can block the initial non-covalent interaction between Apo(a) and ApoB by binding to KIV7-8 of Apo(a), and inhibit the subsequent formation of disulfide bonds, ultimately preventing the assembly of Lp(a) particles without affecting the expression of Lp(a).In November 2024, Eli Lilly and Company announced the Phase II clinical study（NCT05563246）Results. The data shows,Muvalaplin(10 mg, 60 mg, and 240 mg)All dose groupsSignificantly reduced Lp(a) concentration, and showed a significant dose-dependent effect:
Using complete Lp(a) testing,The reduction rates were 47.6%, respectively.（10 mg）、81.7%（60 mg）And 85.8%（240 mg）；
Using apolipoprotein(a) testing,The reductions were 40.4%, respectively.（10 mg）、70.0%（60 mg）And 68.9%（240 mg）。
In addition,The 60 mg and 240 mg doses also achieved statistically significant improvements in ApoB reduction., and there is also data showing that:
Using complete Lp(a) testing, at Week 12The percentage of subjects with Lp(a) levels below 125 nmol/L was 64.2%.（10 mg）、95.9%（60 mg）And 96.7%（240 mg）, while the placebo group was 6.0%.
Using apo(a) testing, the percentage of subjects achieving Lp(a) levels below 125 nmol/L was 38.9%.（10 mg）、81.9%（60 mg）And 77.4%（240 mg）, while the placebo group was 3.6%.
ApoB levels were reduced at all doses, adjusted for placebo.The reduction rates were 8.9%, respectively.（10 mg）、13.1%（60 mg）And 16.1%（240 mg）。
Screenshot Source：Insight DatabaseMuvalaplin as an oral lipid-lowering drug targeting Lp(a),Compared with traditional lipid-lowering drugs, LY3473329Oral administrationBreaks the inconvenience of injectable formulations, greatly improving patient medication adherence and making lipid-lowering treatment more convenient and efficient.。Insight database shows that, currently, there are only 5Oral lipid-lowering drugs targeting Lp(a) are under research,Eli LillyTheMuvalaplin is the furthest along, having already initiated Phase III clinical trials. Besides,HengruiTheHRS-5346 has entered Phase II clinical trials.Jingxin PharmaceuticalofJX2201 and AstraZeneca'sAZD4954 In Phase I clinical trials.Screenshot Source：Insight DatabaseIt is worth mentioning that, in March this year,MSD and HengruiReach an agreement on HRS-5346Exclusive License AgreementAccording to the agreement, Hengrui granted Merck an exclusive license to develop, manufacture, and commercialize HRS-5346 outside of Greater China.In return, Hengrui will receive200 million US dollarsThe initial payment, and is eligible to receive up to a maximum amount based on specific development, registration, and commercialization milestones.$1.77 billionMilestone payments. If HRS-5346 is approved, Hengrui can receive royalties based on its net sales.Cover Source:Corporate LogoDisclaimer:This article is for information sharing only,不代表 Insight 立场和观点, and does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.PR Article Coordination: WeChat insightxbSubmissionWeChat: insightxb; Email: insight@dxy.cn
