Authorised Therapeutic confirmatory (Phase III) ASCVD - Atherosclerotic Cardiovascular Disease

A 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

EU CTIS ID: 2022-502781-24-01

What this study is testing

1. To evaluate the efficacy of enlicitide decanoate (enlicitide) compared with placebo in increasing the time to the first event of coronary heart disease (CHD) death-based major adverse cardiovascular events (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).

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Meets one of the following: a) 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 b) High risk for first major ASCVD event defined as at least 1 of the following: Age ≥50 years with evidence of coronary artery disease (CAD); Age ≥50 years with evidence of atherosclerotic cerebrovascular disease; Age ≥50 years with evidence of PAD; 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 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 likely can't join if

  • CV Conditions: Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
  • CV Conditions: 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)
  • CV Conditions: Has recurrent ventricular tachycardia within 3 months prior to randomization
  • CV Conditions: 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.
See the full eligibility criteria
Who can join
  • Meets one of the following: a) 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 b) High risk for first major ASCVD event defined as at least 1 of the following: Age ≥50 years with evidence of coronary artery disease (CAD); Age ≥50 years with evidence of atherosclerotic cerebrovascular disease; Age ≥50 years with evidence of PAD; 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 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.
What rules you out
  • CV Conditions: Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
  • CV Conditions: 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)
  • CV Conditions: Has recurrent ventricular tachycardia within 3 months prior to randomization
  • CV Conditions: 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)

The study team makes the final eligibility decision.

Where it's taking place

  • South Africa
  • Korea, Republic of
  • Argentina
  • Turkey
  • Chile
  • Australia
  • Canada
  • Mexico
  • Japan
  • Colombia
  • New Zealand
  • United States
  • United Kingdom
  • Peru
  • Taiwan
  • Hong Kong
  • Israel
  • China
  • Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include South Africa; Korea, Republic of; Argentina; Turkey; Chile; Australia and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.