A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05952856
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

Key Dates

Start date
Aug 10, 2023
Status verified
Sep 2025
Primary completion
Jul 28, 2025
Completion
Jul 28, 2025

Study Design

Enrollment
2,912 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Enlicitide Decanoate
    Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
  • Placebo Comparator: Placebo
    Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.

Primary Outcome Measure

Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24 [ Time Frame: Baseline and Week 24 ]

Locations (49)

FacilityCityStateZIPSite coordinators
Alliance for Multispecialty Research, LLC ( Site 0093)DaphneAlabama36526-
G&L Research ( Site 0043)FoleyAlabama36535-
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)PhoenixArizona85020-
National Heart Institute-Research ( Site 0087)Beverly HillsCalifornia90211-
Clinical Trials Research ( Site 0115)SacramentoCalifornia95821-
Velocity Clinical Research, Banning ( Site 0017)San BernardinoCalifornia92408-
Emerson Clinical Research Institute ( Site 0118)Washington D.C.District of Columbia20009-
Excel Medical Clinical Trials ( Site 0053)Boca RatonFlorida33434-
Alliance for Multispecialty Research, LLC ( Site 0088)Coral GablesFlorida33134-
Alliance for Multispecialty Research, LLC ( Site 0094)Fort MyersFlorida33912-
Velocity Clinical Research, Hallandale Beach ( Site 0018)HallandaleFlorida33009-
Jacksonville Center for Clinical Research ( Site 0049)JacksonvilleFlorida32216-
South Broward Research ( Site 0051)MiramarFlorida33027-
Clinical Research Trials of Florida ( Site 0063)TampaFlorida33607-
East Coast Institute for Research, LLC ( Site 0033)MaconGeorgia31210-
Healthcare Research Network - Chicago ( Site 0052)FlossmoorIllinois60422-
Synexus Clinical Research US, Inc. ( Site 0109)EvansvilleIndiana47714-
Midwest Institute For Clinical Research ( Site 0059)IndianapolisIndiana46260-
Alliance for Multispecialty Research, LLC ( Site 0028)LexingtonKentucky40509-
L-MARC Research Center ( Site 0001)LouisvilleKentucky40213-
Velocity Clinical Research, Covington ( Site 0068)CovingtonLouisiana70433-
Velocity Clinical Research Rockville ( Site 0082)RockvilleMaryland20854-
Velocity Clinical Research, Gulfport ( Site 0039)GulfportMississippi39503-
Healthcare Research Network - St. Louis ( Site 0054)HazelwoodMissouri63042-
AB Clinical Trials ( Site 0070)Las VegasNevada89119-
Jubilee Clinical Research ( Site 0106)Las VegasNevada89106-
New Mexico Clinical Research & Osteoporosis Center ( Site 0005)AlbuquerqueNew Mexico87106-
Velocity Clinical Research, Syracuse ( Site 0021)East SyracuseNew York13057-
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)New YorkNew York10029-
Lillestol Research ( Site 0026)FargoNorth Dakota58104-
altoona center for clinical research ( Site 0089)DuncansvillePennsylvania16635-
Cardiology Consultants of Philadelphia Yardley ( Site 0097)YardleyPennsylvania19067-
Piedmont Research Partners ( Site 0090)Fort MillSouth Carolina29707-
Velocity Clinical Research, Greenville ( Site 0023)GreenvilleSouth Carolina29615-
Coastal Carolina Research Center ( Site 0006)North CharlestonSouth Carolina29405-
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009)Rapid CitySouth Dakota57701-
Holston Medical Group ( Site 0048)KingsportTennessee37660-
Alliance for Multispecialty Research, LLC ( Site 0008)KnoxvilleTennessee37920-
Velocity Clinical Research, Dallas ( Site 0114)DallasTexas75230-
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)HoustonTexas77030-
Clinical Trials of Texas, LLC ( Site 0103)San AntonioTexas78229-
Synexus Clinical Research US, Inc. ( Site 0110)Salt Lake CityUtah84106-
Velocity Clinical Research, Salt Lake City ( Site 0019)West JordanUtah84088-
Manassas Clinical Research Center ( Site 0007)ManassasVirginia20110-
Health Research of Hampton Roads, Inc. ( Site 0044)Newport NewsVirginia23606-
Alliance for Multispecialty Research, LLC ( Site 0101)NorfolkVirginia23502-
National Clinical Research, Inc ( Site 0061)RichmondVirginia23294-
Centricity Research Suffolk Family Medicine ( Site 0092)SuffolkVirginia23435-
Rainier Clinical Research Center ( Site 0116)RentonWashington98057-

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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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