Cardiovascular Disease

Last updated: November 1, 2023
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting







Clinical Study ID

  • Ages 18-100
  • All Genders

Study Summary

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

Eligibility Criteria


Inclusion Criteria:

  • 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 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 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.

Study Design

Study Start date:
Estimated Completion Date:

Study Description

Condition: Cardiovascular Disease

Clinical Trial Identifier: NCT06008756

Sponsor: Merck Sharp & Dohme LLC

Looking for participates within a 30-mile radius of the study location.

Connect with a study center

  • AMR Fort Myers

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.