Active (not recruiting) Phase 3 NCT06008756

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

Phase 3 – large-scale trial before approval

Conditions: Arteriosclerosis Hypercholesterolaemia

Sponsor: Merck Sharp & Dohme LLC

trial.available_in:

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Overview

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.

Who can participate

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)

Interventions

Enlicitide Decanoate

DRUG

Placebo

DRUG

Locations 669

Argentina (21)

CIPREC-CIPREC Sede Arenales ( Site 0624)

Buenos Aires , Buenos Aires F.D.

Fundación favaloro para la Docencia e Investigación Médica ( Site 0606)

Buenos Aires , Buenos Aires F.D.

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)

Buenos Aires , Buenos Aires F.D.

Fundación Respirar ( Site 0610)

Buenos Aires , Buenos Aires F.D.

Sanatorio Finochietto ( Site 0626)

Buenos Aires

CEDIC ( Site 0612)

CABA , Buenos Aires

CEMEDIC ( Site 0609)

CABA , Buenos Aires

Centro de Investigaciones Metabólicas (CINME) ( Site 0620)

CABA

Instituto Médico DAMIC ( Site 0603)

Córdoba , Córdoba Province

Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0608)

Corrientes

Framingham Centro Médico ( Site 0625)

La Plata , Buenos Aires

CIMeL ( Site 0613)

Lanus , Buenos Aires

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)

Mar del Plata , Buenos Aires

DIM Clínica Privada ( Site 0627)

Ramos Mejía , Buenos Aires

Instituto de Investigaciones Clinicas Rosario ( Site 0602)

Rosario , Santa Fe Province

Fundacion Estudios Clinicos ( Site 0619)

Rosario , Santa Fe Province

Laboratorio de Hemostasia y Trombosis ( Site 0623)

Rosario , Santa Fe Province

Go Centro Medico San Nicolás ( Site 0621)

San Nicolás de los Arroyos , Buenos Aires

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0615)

Santa Fe , Santa Fe Province

Centro de Investigaciones Clinicas del Litoral ( Site 0607)

Santa Fe

Instituto de Investigaciones Clinicas Zarate ( Site 0600)

Zárate , Buenos Aires

Australia (7)

Paratus Clinical Research Western Sydney ( Site 2805)

Blacktown , New South Wales

The Prince Charles Hospital ( Site 2810)

Brisbane , Queensland

Paratus Clinical Research Canberra ( Site 2804)

Bruce , Australian Capital Territory

Royal Prince Alfred Hospital ( Site 2808)

Camperdown , New South Wales

Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)

Clayton , Victoria

Baker IDI Heart & Diabetes Institute ( Site 2809)

Hoppers Crossing , Victoria

Paratus Clinical Research Central Coast ( Site 2806)

Kanwal , New South Wales

Brazil (18)

Centro de Pesquisa Clinica do Coracao ( Site 0713)

Aracaju , Sergipe

Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0725)

Bragança Paulista , São Paulo

Centro de Pesquisa Clinica do Brasil ( Site 0719)

Brasília , Federal District

Hospital Angelina Caron ( Site 0702)

Campina Grande do Sul , Paraná

Instituto de Pesquisa clinica de Campinas ( Site 0706)

Campinas , São Paulo

Hospital do Rocio ( Site 0721)

Campo Largo , Paraná

Hospital Universitário ( Site 0723)

Canoas , Rio Grande do Sul

Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0728)

Fortaleza , Ceará

Universidade Federal de Goias ( Site 0717)

Goiânia , Goiás

Instituto de Cardiologia do Rio Grande do Sul ( Site 0704)

Porto Alegre , Rio Grande do Sul

Hospital Mae de Deus ( Site 0716)

Porto Alegre , Rio Grande do Sul

Hospital Nossa Senhora da Conceição-FZ PESQUISA E SERVIÇOS EM CARDIOLOGIA CLÍNICA LTDA ( Site 0712)

Porto Alegre , Rio Grande do Sul

IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0715)

Rio de Janeiro

Hospital e Maternidade Christóvão da Gama (HMCG) ( Site 0724)

Santo André , São Paulo

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0707)

São José do Rio Preto , São Paulo

Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0708)

São Paulo , São Paulo

CEPIC - Centro Paulista de Investigação Clínica ( Site 0710)

São Paulo , São Paulo

Integral Pesquisa e Ensino ( Site 0709)

Votuporanga , São Paulo

Canada (10)

Cambridge Cardiac Care Centre ( Site 0508)

Cambridge , Ontario

Ecogene-21 ( Site 0510)

Chicoutimi , Quebec

OCT Research ULC ( Site 0512)

Kelowna , British Columbia

Institut de Cardiologie de Montreal ( Site 0506)

Montreal , Quebec

North York Diagnostic and Cardiac Centre ( Site 0514)

North York , Ontario

Oakville Cardiovascular Research LP ( Site 0507)

Oakville , Ontario

IUCPQ ( Site 0515)

Québec , Quebec

Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur. ( Site 0509)

Terrebonne , Quebec

Corcare ( Site 0511)

Toronto , Ontario

Diex Recherche Trois-Rivieres ( Site 0505)

Trois-Rivières , Quebec

Chile (15)

Biocenter ( Site 0819)

Concepción , Biobio

Espacio Eme ( Site 0806)

Ñuñoa , Region M. de Santiago

Servicios Medicos Godoy ( Site 0810)

Providencia , Region M. de Santiago

Centro Respiratorio Integral - CENRESIN. ( Site 0820)

Quillota , Valparaiso

Enroll SpA ( Site 0803)