A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH

Last updated: May 8, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

3

Condition

Familial Hypercholesterolemia

Hypercholesterolemia

High Cholesterol (Hyperlipidemia)

Treatment

Placebo

MK-0616

Enlicitide Decanoate

Clinical Study ID

NCT05952869
0616-017
2022-502782-14-00
2022-502782-14
MK-0616-017
U1111-1285-4257
  • Ages > 18
  • All Genders

Study Summary

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm

  • Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history

  • Is treated with a moderate- or high-intensity statin medication

  • Is on a stable dose of all background lipid-lowering therapies (LLTs) with noplanned medication change

Exclusion

Exclusion Criteria:

  • Has a history of homozygous familial hypercholesterolemia (FH) based on genetic orclinical criteria, compound heterozygous FH, or double heterozygous FH

  • Has a history of heart failure or heart failure hospitalization within 3 monthsbefore first study visit

  • Is undergoing or previously underwent an LDL-C apheresis program within 3 monthsbefore first study visit or plans to initiate an LDL-C apheresis program

  • Was previously treated/is being treated with certain other cholesterol loweringmedications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors

Study Design

Total Participants: 303
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 08, 2023
Estimated Completion Date:
April 07, 2025

Connect with a study center

  • Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

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

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Universidade Federal Do Ceara ( Site 0702)

    Fortaleza, Ceara 60430-270
    Brazil

    Site Not Available

  • Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0701)

    São Paulo, Sao Paulo 04012-909
    Brazil

    Site Not Available

  • Incor - Instituto do Coracao ( Site 0703)

    Sao Paulo, 05403-000
    Brazil

    Site Not Available

  • Ecogene-21 ( Site 0510)

    Chicoutimi, Quebec G7H 7K9
    Canada

    Site Not Available

  • Institut de Cardiologie de Montreal ( Site 0506)

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Diex Recherche Trois-Rivieres ( Site 0513)

    Trois-Rivieres, Quebec G9A 4P3
    Canada

    Site Not Available

  • Clinical Research Chile SpA ( Site 0804)

    Valdivia, Los Rios 5110683
    Chile

    Site Not Available

  • CDIEM ( Site 0814)

    Providencia, Region M. De Santiago 7500859
    Chile

    Site Not Available

  • Enroll SpA ( Site 0803)

    Santiago, Region M. De Santiago 7500587
    Chile

    Site Not Available

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 0812)

    Santiago, Region M. De Santiago 8330034
    Chile

    Site Not Available

  • Fundación Centro de Investigación Clínica CIC ( Site 0906)

    Medellín, Antioquia 050021
    Colombia

    Site Not Available

  • Ciensalud Ips S A S ( Site 0903)

    Barranquilla, Atlantico 08001
    Colombia

    Site Not Available

  • Clinica de la Costa S.A.S. ( Site 0902)

    Barranquilla, Atlantico 080020
    Colombia

    Site Not Available

  • Salud SURA Calle 100 ( Site 0918)

    Bogotá, Cundinamarca 110231
    Colombia

    Site Not Available

  • Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)

    Brno, Brno-mesto 625 00
    Czechia

    Site Not Available

  • Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)

    Brno, Jihomoravsky Kraj 60200
    Czechia

    Site Not Available

  • Institut Klinicke a Experimentalni Mediciny ( Site 3601)

    Praha, Praha 4 140 21
    Czechia

    Site Not Available

  • Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)

    Helsinki, Uusimaa 00290
    Finland

    Site Not Available

  • Queen Mary Hospital-Medical ( Site 3300)

    Pok Fu Lam,
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital ( Site 3304)

    Shatin, NT
    Hong Kong

    Site Not Available

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)

    Szeged, Csongrad 6725
    Hungary

    Site Not Available

  • Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)

    Budapest, 1122
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)

    Debrecen, 4032
    Hungary

    Site Not Available

  • Hadassah Medical Center ( Site 1709)

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Shaare Zedek Medical Center ( Site 1710)

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Rabin Medical Center ( Site 1717)

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1700)

    Sakhnin, 308100
    Israel

    Site Not Available

  • Radboudumc-internal medicine ( Site 1952)

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Site Not Available

  • Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • Vasculair Onderzoek Centrum Hoorn ( Site 1953)

    Hoorn, Noord-Holland 1625 HV
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Pacific Clinical Research Network - Rotorua ( Site 2902)

    Rotorua, Bay Of Plenty 3010
    New Zealand

    Site Not Available

  • New Zealand Clinical Research (Christchurch) ( Site 2901)

    Christchurch, Canterbury 8011
    New Zealand

    Site Not Available

  • Nordlandssykehuset ( Site 2001)

    Bodø, Nordland 8005
    Norway

    Site Not Available

  • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000)

    Oslo, 0316
    Norway

    Site Not Available

  • Changi General Hospital ( Site 3211)

    Singapore, Central Singapore 529889
    Singapore

    Site Not Available

  • National University Hospital-Department of Medicine ( Site 3212)

    Singapore, Central Singapore 119074
    Singapore

    Site Not Available

  • Hospital de Sant Joan Despí Moisès Broggi ( Site 2335)

    Sant Joan Despí, Cataluna 08970
    Spain

    Site Not Available

  • SALUT SANT JOAN DE REUS-BAIX CAMP (EDP)-Vascular and Metabolism Unit ( Site 2329)

    Reus, Tarragona 43204
    Spain

    Site Not Available

  • HOSPITAL CLINICO DE VALENCIA ( Site 2321)

    Valencia, Valenciana, Comunitat 46010
    Spain

    Site Not Available

  • Mackay Memorial Hospital -Tamshui Branch ( Site 3109)

    New Taipei City, New Taipei 251
    Taiwan

    Site Not Available

  • Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106)

    Taipei City, Taipei 111
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital-Internal Medicine ( Site 3107)

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital ( Site 3100)

    Taipei, 10002
    Taiwan

    Site Not Available

  • Alliance for Multispecialty Research, LLC ( Site 0023)

    Daphne, Alabama 36526
    United States

    Site Not Available

  • Excel Medical Clinical Trials ( Site 0008)

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Advanced Pharma Research ( Site 0007)

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • Progressive Medical Research ( Site 0021)

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Synexus Clinical Research US - Evansville ( Site 0031)

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)

    Troy, Michigan 48098
    United States

    Site Not Available

  • Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Jubilee Clinical Research ( Site 0030)

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Velocity Clinical Research, Salt Lake City ( Site 0004)

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Health Research of Hampton Roads, Inc. ( Site 0020)

    Newport News, Virginia 23606
    United States

    Site Not Available

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