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

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06492291
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Aug 5, 2024
Status verified
Oct 2025
Primary completion
Oct 13, 2028
Completion
Oct 13, 2028

Study Design

Enrollment
3,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enlicitide Decanoate
    Participants will receive 20 mg of enlicitide decanoate orally once daily (QD)

Primary Outcome Measure

Number of participants with one or more adverse events (AEs) [ Time Frame: Up to approximately 3 years ]

Locations (52)

FacilityCityStateZIPSite coordinators
Alliance for Multispecialty Research, LLC ( Site 0027)DaphneAlabama36526-
G&L Research ( Site 0035)FoleyAlabama36535-
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)PhoenixArizona85020-
National Heart Institute-Research ( Site 0029)Beverly HillsCalifornia90211-
Clinical Trials Research ( Site 0054)SacramentoCalifornia95821-
Velocity Clinical Research, Banning ( Site 0023)San BernardinoCalifornia92408-
Emerson Clinical Research Institute ( Site 0017)Washington D.C.District of Columbia20009-
Excel Medical Clinical Trials ( Site 0010)Boca RatonFlorida33434-
Alliance for Multispecialty Research, LLC ( Site 0037)DoralFlorida33172-
Alliance for Multispecialty Research, LLC ( Site 0056)Fort MyersFlorida33912-
Velocity Clinical Research, Hallandale Beach ( Site 0053)HallandaleFlorida33009-
Jacksonville Center for Clinical Research ( Site 0025)JacksonvilleFlorida32216-
South Broward Research ( Site 0012)MiramarFlorida33027-
Progressive Medical Research ( Site 0033)Port OrangeFlorida32127-
Clinical Research Trials of Florida ( Site 0006)TampaFlorida33607-
Clinical Site Partners, LLC dba Flourish Research ( Site 0004)Winter ParkFlorida32789-
East Coast Institute for Research, LLC ( Site 0020)MaconGeorgia31210-
Healthcare Research Network - Chicago ( Site 0051)FlossmoorIllinois60422-
Synexus Clinical Research US - Evansville ( Site 0005)EvansvilleIndiana47714-
Midwest Institute For Clinical Research ( Site 0052)IndianapolisIndiana46260-
Alliance for Multispecialty Research, LLC ( Site 0001)LexingtonKentucky40509-
L-MARC Research Center ( Site 0011)LouisvilleKentucky40213-
Velocity Clinical Research, Covington ( Site 0026)CovingtonLouisiana70433-
Velocity Clinical Research Rockville ( Site 0022)RockvilleMaryland20854-
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)TroyMichigan48098-
Velocity Clinical Research, Gulfport ( Site 0032)GulfportMississippi39503-
Healthcare Research Network - St. Louis ( Site 0040)HazelwoodMissouri63042-
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031)LincolnNebraska68510-
AB Clinical Trials ( Site 0002)Las VegasNevada89119-
Jubilee Clinical Research ( Site 0049)Las VegasNevada89106-
New Mexico Clinical Research & Osteoporosis Center ( Site 0043)AlbuquerqueNew Mexico87106-
Velocity Clinical Research, Syracuse ( Site 0014)East SyracuseNew York13057-
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042)New YorkNew York10029-
Lillestol Research ( Site 0030)FargoNorth Dakota58104-
altoona center for clinical research ( Site 0024)DuncansvillePennsylvania16635-
Cardiology Consultants of Philadelphia Yardley ( Site 0021)YardleyPennsylvania19067-
Velocity Clinical Research, Anderson ( Site 0015)AndersonSouth Carolina29621-
Piedmont Research Partners ( Site 0045)Fort MillSouth Carolina29707-
Coastal Carolina Research Center ( Site 0055)North CharlestonSouth Carolina29405-
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038)Rapid CitySouth Dakota57701-
Holston Medical Group ( Site 0034)KingsportTennessee37660-
Alliance for Multispecialty Research, LLC ( Site 0050)KnoxvilleTennessee37920-
Velocity Clinical Research, Dallas ( Site 0028)DallasTexas75230-
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0009)HoustonTexas77030-
Clinical Trials of Texas, LLC ( Site 0016)San AntonioTexas78229-
Synexus Clinical Research US, Inc. ( Site 0003)Salt Lake CityUtah84106-
Velocity Clinical Research, Salt Lake City ( Site 0041)West JordanUtah84088-
Manassas Clinical Research Center ( Site 0007)ManassasVirginia20110-
Health Research of Hampton Roads, Inc. ( Site 0019)Newport NewsVirginia23606-
Alliance for Multispecialty Research, LLC ( Site 0008)NorfolkVirginia23502-
National Clinical Research, Inc ( Site 0044)RichmondVirginia23294-
Rainier Clinical Research Center ( Site 0013)RentonWashington98057-

Find similar trials in Daphne, AL

By research site
Alliance for Multispecialty Research, LLC· Daphne, ALG&L Research· Foley, ALSynexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix· Phoenix, AZNational Heart Institute-Research· Beverly Hills, CAClinical Trials Research· Sacramento, CAVelocity Clinical Research, Banning· San Bernardino, CA

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