Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
a study on Arteriosclerosis Hypercholesterolaemia Cholesterol
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Torrance, California and other locations
- Dates
- study startedcompletion around
Description
Summary
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.
Official Title
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
Keywords
Arteriosclerosis, Hypercholesterolaemia, Hypercholesterolemia, Enlicitide Decanoate
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
You CAN'T join if...
- 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)
- 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.
Locations
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0058)
accepting new patients
Torrance California 90502 United States - Westside Medical Associates of Los Angeles-Research ( Site 0077)
accepting new patients
Beverly Hills California 90211 United States - Premiere Medical Center ( Site 0093)
accepting new patients
Toluca Lake California 91602 United States - America Clinical Trials-Research Dept ( Site 0104)
accepting new patients
Tarzana California 91356-3551 United States - Velocity Clinical Research, Westlake ( Site 0039)
accepting new patients
Los Angeles California 90057 United States - Carbon Health - Pasadena ( Site 0149)
completed
Pasadena California 91101 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Merck Sharp & Dohme LLC
- Links
- Merck Clinical Trials Information Plain Language Summary
- ID
- NCT06008756
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 14550 study participants
- Last Updated