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Oral PCSK9 inhibitor for reducing cardiovascular events

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

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06008756

This study is testing if a new oral medication can help people at high risk for heart problems, like heart attacks and strokes, stay healthier for longer compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment14550 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations665 sites (Alexander City, Alabama and 664 other locations)
Trial IDNCT06008756 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized, placebo-controlled study evaluates the efficacy and safety of enlicitide decanoate, an oral PCSK9 inhibitor, in individuals at high cardiovascular risk. The primary goal is to determine how effectively this medication can increase the time until the first occurrence of major adverse cardiovascular events (MACE), such as heart attacks and strokes, compared to a placebo. Participants will be monitored for significant cardiovascular outcomes over the course of the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a history of major atherosclerotic cardiovascular disease or those at high risk for such events.

Not a fit: Patients who do not meet the age or cardiovascular risk criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of major cardiovascular events in high-risk patients.

How similar studies have performed: Other studies involving PCSK9 inhibitors have shown promising results in reducing cardiovascular events, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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

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.
* Has a fasting triglyceride value ≥400 mg/dL (≥4.52 mmol/L) at Visit 1 (Screening)

Where this trial is running

Alexander City, Alabama and 664 other locations

+615 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ArteriosclerosisHypercholesterolaemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.