Dose Response and Safety of an Oral PCSK9i, NNC0385-0434, in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk on Maximally Tolerated Statin Dose and Other Lipid-lowering Therapy Requiring Further LDL-C Reduction(NN6435-4697) - NA

Hirata Takashi0 个研究点目标入组 267 人开始时间: 2021年10月29日最近更新: 2023年10月17日

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 267

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Efficacy - Superiority of oral NNC0385-0434 (all doses) vs placebo in LDL-C lowering was confirmed after 12 weeks of treatment - Oral NNC0385-0434 (15, 40 and 100 mg) demonstrated dose-dependent LDL-C lowering - LDLLDL-C lowering was similar for oral NNC0385-0434 100 mg and evolocumab 140 mg - Oral NNC0385-0434 improved lipid parameters compared to placebo Safety -Multiple doses of oral NNC0385-0434 were well-tolerated and no safety concerns were identified

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 40age old 至 ot applicable（—）
性别: All

入选标准

•Males or females of non-childbearing potential.
•Established atherosclerotic cardiovascular disease (ASCVD) (criteria a) or ASCVD risk (criteria b):
•a) Age 40 years or older at the time of signing informed consent and history of ASCVD
•b) Age above 50 years at the time of signing informed consent and with ASCVD risk
•Serum LDL-C above or equal to 1.8 mmol/L (above or equal to 70 mg/dL) as measured by the central laboratory at screening.
•Japanese participants: Serum LDL-C above or equal to 2.6 mmol/L (above or equal to 100 mg/dL) for participants of 40 years of age or older and with a history of coronary heart disease, and serum LDL-C above or equal to 3.1 mmol/L (above or equal to 120 mg/dL) for all other Japanese participants
•Participants must be on maximally tolerated dose of statins.
•Participants not receiving statin must have documented evidence of intolerance to all doses of at least two different statins.

排除标准

•Treatment with PCSK9i therapy (alirocumab or evolocumab within 90 days prior to screening) or PCSK9 siRNA therapy (inclisiran within 12 months prior to screening).
•Fasting triglyceride above 4.52 mmol/L (above 400 mg/dL) as measured by the central laboratory at screening.
•Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
•Renal impairment with eGFR less than 30 ml/min/1.73 m2 as measured by the central laboratory at screening

研究者

发起方

Hirata Takashi

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