ACTIVE_NOT_RECRUITING

Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

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Conditions

Hypercholesterolemia

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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 an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).

Official Title

A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia

Quick Facts

Study Start:2024-08-05
Study Completion:2028-10-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06492291

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. * Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study \[MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)\] per protocol (including the final assessments/procedures of their parent study)
  2. * Had an overall study intervention compliance ≥80% while participating in their parent study
  1. * Has discontinued study intervention in their parent study
  2. * Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
  3. * Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
  4. * Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Alliance for Multispecialty Research, LLC ( Site 0027)
Daphne, Alabama, 36526
United States
G&L Research ( Site 0035)
Foley, Alabama, 36535
United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)
Phoenix, Arizona, 85020
United States
National Heart Institute-Research ( Site 0029)
Beverly Hills, California, 90211
United States
Clinical Trials Research ( Site 0054)
Sacramento, California, 95821
United States
Velocity Clinical Research, Banning ( Site 0023)
San Bernardino, California, 92408
United States
Emerson Clinical Research Institute ( Site 0017)
Washington D.C., District of Columbia, 20009
United States
Excel Medical Clinical Trials ( Site 0010)
Boca Raton, Florida, 33434
United States
Alliance for Multispecialty Research, LLC ( Site 0037)
Coral Gables, Florida, 33134
United States
Alliance for Multispecialty Research, LLC ( Site 0056)
Fort Myers, Florida, 33912
United States
Velocity Clinical Research, Hallandale Beach ( Site 0053)
Hallandale, Florida, 33009
United States
Jacksonville Center for Clinical Research ( Site 0025)
Jacksonville, Florida, 32216
United States
South Broward Research ( Site 0012)
Miramar, Florida, 33027
United States
Progressive Medical Research ( Site 0033)
Port Orange, Florida, 32127
United States
Clinical Research Trials of Florida ( Site 0006)
Tampa, Florida, 33607
United States
Clinical Site Partners, LLC dba Flourish Research ( Site 0004)
Winter Park, Florida, 32789
United States
East Coast Institute for Research, LLC ( Site 0020)
Macon, Georgia, 31210
United States
Healthcare Research Network - Chicago ( Site 0051)
Flossmoor, Illinois, 60422
United States
Synexus Clinical Research US - Evansville ( Site 0005)
Evansville, Indiana, 47714
United States
Midwest Institute For Clinical Research ( Site 0052)
Indianapolis, Indiana, 46260
United States
Alliance for Multispecialty Research, LLC ( Site 0001)
Lexington, Kentucky, 40509
United States
L-MARC Research Center ( Site 0011)
Louisville, Kentucky, 40213
United States
Velocity Clinical Research, Covington ( Site 0026)
Covington, Louisiana, 70433
United States
Velocity Clinical Research Rockville ( Site 0022)
Rockville, Maryland, 20854
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)
Troy, Michigan, 48098
United States
Velocity Clinical Research, Gulfport ( Site 0032)
Gulfport, Mississippi, 39503
United States
Healthcare Research Network - St. Louis ( Site 0040)
Hazelwood, Missouri, 63042
United States
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031)
Lincoln, Nebraska, 68510
United States
Jubilee Clinical Research ( Site 0049)
Las Vegas, Nevada, 89106
United States
AB Clinical Trials ( Site 0002)
Las Vegas, Nevada, 89119
United States
New Mexico Clinical Research & Osteoporosis Center ( Site 0043)
Albuquerque, New Mexico, 87106
United States
Velocity Clinical Research, Syracuse ( Site 0014)
East Syracuse, New York, 13057
United States
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042)
New York, New York, 10029
United States
Lillestol Research ( Site 0030)
Fargo, North Dakota, 58104
United States
altoona center for clinical research ( Site 0024)
Duncansville, Pennsylvania, 16635
United States
Cardiology Consultants of Philadelphia Yardley ( Site 0021)
Yardley, Pennsylvania, 19067
United States
Velocity Clinical Research, Anderson ( Site 0015)
Anderson, South Carolina, 29621
United States
Piedmont Research Partners ( Site 0045)
Fort Mill, South Carolina, 29707
United States
Coastal Carolina Research Center ( Site 0055)
North Charleston, South Carolina, 29405
United States
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038)
Rapid City, South Dakota, 57701
United States
Holston Medical Group ( Site 0034)
Kingsport, Tennessee, 37660
United States
Alliance for Multispecialty Research, LLC ( Site 0050)
Knoxville, Tennessee, 37920
United States
Velocity Clinical Research, Dallas ( Site 0028)
Dallas, Texas, 75230
United States
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0009)
Houston, Texas, 77030
United States
Clinical Trials of Texas, LLC ( Site 0016)
San Antonio, Texas, 78229
United States
Synexus Clinical Research US, Inc. ( Site 0003)
Salt Lake City, Utah, 84106
United States
Velocity Clinical Research, Salt Lake City ( Site 0041)
West Jordan, Utah, 84088
United States
Manassas Clinical Research Center ( Site 0007)
Manassas, Virginia, 20110
United States
Health Research of Hampton Roads, Inc. ( Site 0019)
Newport News, Virginia, 23606
United States
Alliance for Multispecialty Research, LLC ( Site 0008)
Norfolk, Virginia, 23502
United States
National Clinical Research, Inc ( Site 0044)
Richmond, Virginia, 23294
United States
Rainier Clinical Research Center ( Site 0013)
Renton, Washington, 98057
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 Date2024-08-05
Study Completion Date2028-10-13

Study Record Updates

Study Start Date2024-08-05
Study Completion Date2028-10-13

Terms related to this study

Additional Relevant MeSH Terms

  • Hypercholesterolemia