NCT06008756进行中（未招募）3 期
Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 14,550
- 试验地点
- 669
- 主要终点
- Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus
研究概览
简要总结
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets one of the following:
- •Age ≥18 years with a history of a major atherosclerotic cardiovascular disease (ASCVD) event defined as at least 1 of the following: ≥30 days post MI (presumed Type 1 due to plaque rupture or erosion); ≥30 days post ischemic stroke (presumed due to atherosclerosis); or ≥30 days post successful peripheral (carotid or lower extremity) arterial revascularization (surgical or endovascular) or major (ankle or above) amputation due to atherosclerosis; or
- •High risk for first major ASCVD event defined as at least 1 of the following: Age ≥50 years with evidence of coronary artery disease; Age ≥50 years with evidence of atherosclerotic cerebrovascular disease; Age ≥50 years with evidence of peripheral arterial disease; or Age ≥60 years with diabetes mellitus and at least one of the following: microvascular disease or urine albumin-creatinine ratio ≥30 mg/mmol within 6 months before Visit 1, daily insulin use, or diabetes for ≥10 years
- •Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening) as follows:
- •History of major ASCVD Event: LDL-C ≥70 mg/dL (1.81 mmol/L) OR non-HDL-C ≥100 mg/dL (2.59 mmol/L)
- •High risk for first major ASCVD Event: LDL-C ≥90 mg/dL (2.33 mmol/L) OR non-HDL-C ≥120 mg/dL (3.11 mmol/L)
- •Is treated with moderate- or high-intensity statin (± nonstatin lipid-lowering therapy [LLT]) at Visit 1
- •Is on a stable dose of all background LLTs (including statin and nonstatin agents) for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study
排除标准
- •Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
- •Has New York Heart Association Class IV heart failure, last known Left Ventricular Ejection Fraction ≤25% by any imaging method, or had a Heart Failure hospitalization within 3 months before Visit 1 (Screening)
- •Has recurrent ventricular tachycardia within 3 months prior to randomization
- •Has a planned arterial revascularization procedure
- •Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program
- •Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout.
- •Has a fasting triglyceride value ≥400 mg/dL (≥4.52 mmol/L) at Visit 1 (Screening)
研究组 & 干预措施
Enlicitide Decanoate
Experimental
Participants receive enlicitide decanoate 20 mg once daily.
干预措施: Enlicitide Decanoate (Drug)
Placebo
Placebo Comparator
Participants receive placebo once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus
时间窗: From date of randomization until the date of first occurrence of CHD death-based MACE-plus, assessed up to approximately 6 years
Time to the first occurrence of CHD death-based MACE-plus, which is defined as any of the following: coronary heart disease death, myocardial infarction (MI), ischemic stroke (fatal and nonfatal), acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or peripheral).
次要结局
- Time to First Event of MI(From date of randomization until the date of MI, assessed up to approximately 6 years)
- Time to First Occurrence of 3-point MACE(From date of randomization until the date of first occurrence of 3-point MACE, assessed up to approximately 6 years)
- Time to First Occurrence of Cardiovascular (CV) Death-Based MACE Plus(From date of randomization until the date of first occurrence of CV death-based MACE plus, assessed up to approximately 6 years)
- Time to CV Death(From date of randomization until the date of CV death, assessed up to approximately 6 years)
- Number of Participants Discontinuing from Study Therapy Due to AE(Up to ~6 years)
- Time to First Occurrence of CHD Death or MI(From date of randomization until the date of first occurrence of CHD death or MI, assessed up to approximately 6 years)
- Time to All-Cause Death(From date of randomization until the date of death, assessed up to approximately 6 years)
- Time to First Event of Urgent Arterial Revascularization(From date of randomization until the date of urgent arterial revascularization, assessed up to approximately 6 years)
- Percent Change from Baseline in Apolipoprotein B(Baseline and Week 52)
- Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) cholesterol(Baseline and Week 52)
- Percent Change from Baseline in Lipoprotein (a)(Baseline and Week 52)
- Time to CHD Death(From date of randomization until the date of CHD death, assessed up to approximately 6 years)
- Time to First Event of Ischemic Stroke(From date of randomization until the date of first occurrence of ischemic stroke, assessed up to approximately 6 years)
- Time to First Event of Acute Limb Ischemia or Major Amputation(From date of randomization until the date of first occurrence of acute limb ischemia or major amputation, assessed up to approximately 6 years)
- Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline and Week 52)
- Number of Participants with an Adverse Event (AE)(Up to ~6 years)
研究者
研究点 (669)
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