MK-0616 Cardiovascular Outcomes Study

JRCT ID: jRCT2071230064

Registered date:14/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: hypercholesterolemia
• Date of first enrollment: 30/10/2023
• Target sample size: 280
• Countries of recruitment: USA,Japan,Canada,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Peru,Japan,Australia,Japan,Hong Kong,Japan,New Zealand,Japan,South Korea,Japan,Taiwan,Japan,China,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Turkiye,Japan,UK,Japan
• Study type: Interventional

Intervention(s)

Experimental: MK-0616
Participants will take MK-0616 20 mg QD
Placebo Comparator: Placebo
Participants will take MK-0616 matching placebo QD

Outcome(s)

• Primary Outcome: - increasing the time to the first event of CHD death-based MACE plus [coronary heart disease death, MI, ischemic stroke (fatal and nonfatal), acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or peripheral)]

Secondary Outcome

- increasing the time to the first event of 3-point MACE (cardiovascular death, MI, ischemic stroke)
- increasing the time to the first event of CV death-based MACE plus [cardiovascular death, MI, ischemic stroke, acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or peripheral)]
- increasing the time to the first event of either coronary heart disease death or MI
- increasing the time to cardiovascular death
- increasing the time to all-cause death
- increasing the time to the first event of each of the individual components of the primary endpoint
- percent change from baseline in LDL-C, ApoB, non-HDL-C, and Lp(a) at Week 52
- safety and tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Meets one of the following:
1. 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
2. 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:
1. 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)
2. 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

Exclude criteria

- 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 4 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)
- Has history of severe renal insufficiency defined as estimated glomerular filtration rate <30 mL/min/1.73 m2 at Visit 1 (Screening) or has end-stage renal disease on dialysis.

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT06008756