Status:
ACTIVE_NOT_RECRUITING
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Arteriosclerosis
Hypercholesterolaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 29 2029
Estimated Enrollment :
14550 Patients enrolled
Trial Details
Trial ID
NCT06008756
Start Date
October 9 2023
End Date
November 29 2029
Last Update
November 13 2025
Active Locations (669)
Enter a location and click search to find clinical trials sorted by distance.
1
Advanced Cardiovascular - Alexander City ( Site 0156)
Alexander City, Alabama, United States, 35010
2
Central Research Associates ( Site 0118)
Birmingham, Alabama, United States, 35205
3
St. Vincent's Birmingham Hospital ( Site 0181)
Birmingham, Alabama, United States, 35205
4
Central Alabama Research ( Site 0109)
Birmingham, Alabama, United States, 35209