ACTIVE_NOT_RECRUITING

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

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Conditions

ArteriosclerosisHypercholesterolaemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-09
Study Completion:2029-11-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06008756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets one of the following:
  2. 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
  3. 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
  4. * Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening) as follows:
  5. 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)
  6. 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)
  7. * Is treated with moderate- or high-intensity statin (± nonstatin lipid-lowering therapy \[LLT\]) at Visit 1
  8. * 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
  1. * Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
  2. * 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)
  3. * Has recurrent ventricular tachycardia within 3 months prior to randomization
  4. * Has a planned arterial revascularization procedure
  5. * 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
  6. * Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout.
  7. * Has a fasting triglyceride value ≥400 mg/dL (≥4.52 mmol/L) at Visit 1 (Screening)

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Advanced Cardiovascular - Alexander City ( Site 0156)
Alexander City, Alabama, 35010
United States
Central Research Associates ( Site 0118)
Birmingham, Alabama, 35205
United States
St. Vincent's Birmingham Hospital ( Site 0181)
Birmingham, Alabama, 35205
United States
Central Alabama Research ( Site 0109)
Birmingham, Alabama, 35209
United States
Alliance for Multispecialty Research, LLC ( Site 0076)
Daphne, Alabama, 36526
United States
G&L Research ( Site 0042)
Foley, Alabama, 36535
United States
NextStage Clinical Research - Phoenix - (01) ( Site 0191)
Glendale, Arizona, 85306
United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0066)
Phoenix, Arizona, 85020
United States
Medical Investigations Inc. ( Site 0188)
Little Rock, Arkansas, 72211
United States
National Heart Institute-Research ( Site 0077)
Beverly Hills, California, 90211
United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0130)
La Jolla, California, 92037
United States
Chemidox Clinical Trials ( Site 0145)
Lancaster, California, 93534
United States
Velocity Clinical Research, Westlake ( Site 0039)
Los Angeles, California, 90057
United States
Carbon Health - Pasadena ( Site 0149)
Pasadena, California, 91101
United States
Carbon Health - San Mateo - Hillsdale Mall ( Site 0151)
San Mateo, California, 94403
United States
America Clinical Trials-Research Dept ( Site 0104)
Tarzana, California, 91356-3551
United States
Premiere Medical Center ( Site 0093)
Toluca Lake, California, 91602
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0058)
Torrance, California, 90502
United States
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0146)
Aurora, Colorado, 80045
United States
South Denver Cardiology Associates ( Site 0167)
Littleton, Colorado, 80120
United States
Cardiology Associates of Fairfield County, P.C. ( Site 0159)
Stamford, Connecticut, 06905
United States
Chase Medical Research, LLC ( Site 0046)
Waterbury, Connecticut, 06708
United States
Emerson Clinical Research Institute ( Site 0143)
Washington, District of Columbia, 20009
United States
Excel Medical Clinical Trials ( Site 0052)
Boca Raton, Florida, 33434
United States
Advanced Pharma Research ( Site 0040)
Cutler Bay, Florida, 33189
United States
Alliance for Multispecialty Research, LLC ( Site 0083)
Fort Myers, Florida, 33912
United States
Westside Center for Clinical Research ( Site 0049)
Jacksonville, Florida, 32205
United States
University of Florida - Jacksonville ( Site 0166)
Jacksonville, Florida, 32209
United States
East Coast Institute for Research, LLC ( Site 0031)
Jacksonville, Florida, 32216
United States
Jacksonville Center for Clinical Research ( Site 0048)
Jacksonville, Florida, 32216
United States
East Coast Institute for Research ( Site 0034)
Lake City, Florida, 32055
United States
Inpatient Research Clinic ( Site 0041)
Miami Lakes, Florida, 33014
United States
Columbus Clinical Services ( Site 0026)
Miami, Florida, 33125
United States
Miami Cardiac & Vascular Institute-Ambulatory Research ( Site 0059)
Miami, Florida, 33173
United States
Eminat ( Site 0082)
Miramar, Florida, 33027
United States
Ocala Research Institute - Ocala - Southwest 20th Place ( Site 0079)
Ocala, Florida, 34471
United States
Progressive Medical Research ( Site 0045)
Port Orange, Florida, 32127
United States
St Johns Center for Clinical Research ( Site 0016)
Saint Augustine, Florida, 32086
United States
Clinical Site Partners LLC, dba CSP Orlando ( Site 0067)
Winter Park, Florida, 32789
United States
East Coast Institute for Research, LLC ( Site 0032)
Macon, Georgia, 31210
United States
North Georgia Clinical Research ( Site 0128)
Woodstock, Georgia, 30189
United States
Bingham Memorial Hospital ( Site 0195)
Blackfoot, Idaho, 83221
United States
Synexus Clinical Research US, Inc. ( Site 0084)
Chicago, Illinois, 60602
United States
Great Lakes Clinical Trials - Ravenswood ( Site 0056)
Chicago, Illinois, 60640
United States
Healthcare Research Network - Chicago ( Site 0051)
Flossmoor, Illinois, 60422
United States
Great Lakes Clinical Trials - Gurnee ( Site 0134)
Gurnee, Illinois, 60031
United States
Alliance for Multispecialty Research, LLC ( Site 0173)
Park Ridge, Illinois, 60068
United States
Alliance for Multispecialty Research - Medisphere Medical Research Center ( Site 0080)
Evansville, Indiana, 47714
United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0154)
Fort Wayne, Indiana, 46845
United States
Franciscan Physician Network - Indiana Heart Physicians ( Site 0141)
Indianapolis, Indiana, 46237
United States
Reid Physician Associates ( Site 0174)
Richmond, Indiana, 47374
United States
University of Kansas Medical Center ( Site 0004)
Kansas City, Kansas, 66160
United States
Cotton O'Neil Clinical Research Center ( Site 0095)
Topeka, Kansas, 66606
United States
Alliance for Multispecialty Research, LLC ( Site 0116)
Wichita, Kansas, 67207
United States
Alliance for Multispecialty Research, LLC ( Site 0027)
Lexington, Kentucky, 40509
United States
L-MARC Research Center ( Site 0001)
Louisville, Kentucky, 40213
United States
Avant Research Associates ( Site 0103)
Crowley, Louisiana, 70526
United States
IMA Clinical Research- Monroe- North 18th Street ( Site 0111)
Monroe, Louisiana, 71201
United States
Northeast Cardiology Associates ( Site 0168)
Bangor, Maine, 04401
United States
Flourish Research - Bowie ( Site 0190)
Bowie, Maryland, 20715
United States
Centennial Medical Group ( Site 0179)
Columbia, Maryland, 21045
United States
Brigham and Women's Hospital-Cardiovascular Medicine ( Site 0147)
Boston, Massachusetts, 02115
United States
Boston Clinical Trials ( Site 0029)
Boston, Massachusetts, 02131
United States
Alliance for Multispecialty Research, LLC. ( Site 0171)
Dearborn, Michigan, 48126
United States
Healthy Heart Cardiology ( Site 0113)
Grand Rapids, Michigan, 49546
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0003)
Troy, Michigan, 48098
United States
Trinity Health-Michigan d/b/a Michigan Heart ( Site 0186)
Ypsilanti, Michigan, 48197
United States
Fairview Health Services ( Site 0024)
Maplewood, Minnesota, 55109
United States
Abbott Northwestern Hospital ( Site 0199)
Minneapolis, Minnesota, 55407
United States
University of Minnesota, Lillehei Clinical Research Unit ( Site 0193)
Minneapolis, Minnesota, 55455
United States
Velocity Clinical Research, Gulfport ( Site 0038)
Gulfport, Mississippi, 39503
United States
Cardiology Associates of North Mississippi ( Site 0169)
Tupelo, Mississippi, 38801
United States
Healthcare Research Network - St. Louis ( Site 0053)
Hazelwood, Missouri, 63042
United States
Alliance for Multispecialty Research, LLC ( Site 0071)
Kansas City, Missouri, 64114
United States
Skyline Medical Center/CCT Research ( Site 0148)
Elkhorn, Nebraska, 68022
United States
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0078)
Lincoln, Nebraska, 68510
United States
CHI Health Clinic Heart Institute ( Site 0180)
Lincoln, Nebraska, 68526
United States
Excel Clinical Research, LLC ( Site 0123)
Las Vegas, Nevada, 89109
United States
Clinical Research of South Nevada ( Site 0135)
Las Vegas, Nevada, 89121-4350
United States
Advanced Heart Care - Bridgewater Route 22 ( Site 0160)
Bridgewater, New Jersey, 08807
United States
Cardiovascular Associates of the Delaware Valley ( Site 0162)
Washington Township, New Jersey, 08080
United States
New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
Albuquerque, New Mexico, 87106
United States
Velocity Clinical Research, Binghamton ( Site 0063)
Binghamton, New York, 13905
United States
Central New York Clinical Research ( Site 0044)
Manlius, New York, 13104
United States
North Shore Diabetes & Endocrine Associates ( Site 0165)
New Hyde Park, New York, 11042
United States
Mid Hudson Medical Research ( Site 0087)
New Windsor, New York, 12553
United States
NYU Langone Health ( Site 0099)
New York, New York, 10016
United States
Rochester Clinical Research, Inc. ( Site 0098)
Rochester, New York, 14609
United States
Laurelton Heart Specialist PC ( Site 0092)
Rosedale, New York, 11422
United States
Duke University Health System (DUHS) ( Site 0153)
Durham, North Carolina, 27710
United States
Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0142)
Winston-Salem, North Carolina, 27157
United States
Lillestol Research ( Site 0025)
Fargo, North Dakota, 58104
United States
Altru Health System ( Site 0197)
Grand Forks, North Dakota, 58201
United States
Velocity Clinical Research, Springdale ( Site 0112)
Cincinnati, Ohio, 45246
United States
Cleveland Clinic Main ( Site 0121)
Cleveland, Ohio, 44195
United States
The Ohio State Wexner Medical Center ( Site 0200)
Columbus, Ohio, 43203
United States
Remington-Davis, Inc. ( Site 0183)
Columbus, Ohio, 43215
United States
Premier Cardiovascular Institute ( Site 0136)
Dayton, Ohio, 45414
United States
Genesis Healthcare System-Pharmacy Research ( Site 0163)
Zanesville, Ohio, 43701
United States
South Oklahoma Heart Research ( Site 0164)
Oklahoma City, Oklahoma, 73135
United States
Capital Area Research, LLC ( Site 0139)
Camp Hill, Pennsylvania, 17011
United States
Guthrie Medical Group, P.C. ( Site 0176)
Sayre, Pennsylvania, 18840
United States
Cardiology Consultants of Philadelphia Yardley ( Site 0072)
Yardley, Pennsylvania, 19067
United States
Velocity Clinical Research, Anderson ( Site 0022)
Anderson, South Carolina, 29621
United States
Coastal Carolina Research Center ( Site 0006)
North Charleston, South Carolina, 29405
United States
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009)
Rapid City, South Dakota, 57701
United States
Holston Medical Group ( Site 0106)
Bristol, Tennessee, 37620
United States
Holston Medical Group ( Site 0047)
Kingsport, Tennessee, 37660
United States
Alliance for Multispecialty Research, LLC ( Site 0008)
Knoxville, Tennessee, 37909
United States
PharmaTex Research, LLC ( Site 0182)
Amarillo, Texas, 79106
United States
Texas Diabetes and Endocrinology, P.A. ( Site 0187)
Austin, Texas, 78731
United States
Southwest Family Medicine Associates ( Site 0189)
Dallas, Texas, 75235
United States
Prolato Clinical Research Center ( Site 0108)
Houston, Texas, 77054
United States
Permian Research Foundation ( Site 0157)
Odessa, Texas, 79761
United States
LinQ Research ( Site 0101)
Pearland, Texas, 77584
United States
Northeast Clinical Research of San Antonio ( Site 0011)
San Antonio, Texas, 78233
United States
Discovery Clinical Trials ( Site 0096)
San Antonio, Texas, 78258
United States
Sugar Lakes Family Practice, PA ( Site 0094)
Sugar Land, Texas, 77479
United States
LinQ Research - Tomball ( Site 0208)
Tomball, Texas, 77375
United States
Northwest Houston Heart Center-Northwest Houston Clinical Research, PLLC ( Site 0158)
Tomball, Texas, 77375
United States
NextStage Clinical Research - Waco ( Site 0196)
Waco, Texas, 76712
United States
Synexus Clinical Research US, Inc. ( Site 0086)
Salt Lake City, Utah, 84106
United States
Highland Clinical Research ( Site 0122)
Salt Lake City, Utah, 84124
United States
Velocity Clinical Research, Salt Lake City ( Site 0019)
West Jordan, Utah, 84088
United States
Burke Internal Medicine and Research ( Site 0035)
Burke, Virginia, 22015
United States
Charlottesville Medical Research ( Site 0030)
Charlottesville, Virginia, 22911
United States
Virginia Heart ( Site 0097)
Falls Church, Virginia, 22042
United States
Carient Heart & Vascular - Manassas ( Site 0170)
Manassas, Virginia, 20109
United States
Manassas Clinical Research Center ( Site 0007)
Manassas, Virginia, 20110
United States
Health Research of Hampton Roads, Inc. ( Site 0043)
Newport News, Virginia, 23606
United States
Alliance for Multispecialty Research, LLC ( Site 0068)
Norfolk, Virginia, 23502
United States
Centricity Research Suffolk Family Medicine ( Site 0105)
Suffolk, Virginia, 23435
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-09
Study Completion Date2029-11-29

Study Record Updates

Study Start Date2023-10-09
Study Completion Date2029-11-29

Terms related to this study

Additional Relevant MeSH Terms

  • Arteriosclerosis
  • Hypercholesterolaemia