Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Conditions

• Arteriosclerosis
• Hypercholesterolaemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enlicitide Decanoate — DRUG
  Enlicitide Decanoate 20 mg tablet taken by mouth.
• Placebo — DRUG
  Placebo tablet matched to enlicitide decanoate taken by mouth.

Study Details

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.

Key Dates

Start date

Oct 9, 2023

Status verified

Apr 2026

Primary completion

Nov 29, 2029

Completion

Nov 29, 2031

Study Design

Enrollment

14,550 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Blinded Portion: Enlicitide Decanoate
  Participants receive enlicitide decanoate 20 mg once daily.
• Placebo Comparator: Blinded Portion: Placebo
  Participants receive placebo once daily.
• Experimental: Open-Label Extension: Enlicitide Decanoate
  Participants who complete the blinded portion may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate once daily up to 2 years.

Primary Outcome Measure

Blinded Period: Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus [ Time Frame: From date of randomization until the date of first occurrence of CHD death-based MACE-plus, assessed up to approximately 6 years ]

Locations (132)

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