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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

3,000

Participants

Timeline

Start Date

August 5, 2024

Primary Completion Date

October 13, 2028

Study Completion Date

October 13, 2028

Conditions
Hypercholesterolemia
Interventions
DRUG

Enlicitide Decanoate

Oral tablet

Trial Locations (222)

111

Shin Kong Wu Ho-Su Memorial Hospital ( Site 3110), Taipei City

112

Taipei Veterans General Hospital ( Site 3106), Taipei

251

Mackay Memorial Hospital -Tamsui Branch ( Site 3109), New Taipei City

704

National Cheng Kung University Hospital-Internal Medicine ( Site 3107), Tainan City

1122

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

1818

Soweto Clinical Trials Centre ( Site 2203), Soweto

2050

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

2193

Charlotte Maxeke Johannesburg Academic Hospital ( Site 2202), Johannesburg

3010

Pacific Clinical Research Network - Rotorua ( Site 2902), Rotorua

3168

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

4032

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

6725

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

7500

TREAD Research ( Site 2201), Cape Town

7530

Tiervlei Trial Centre ( Site 2205), Cape Town

7925

University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2200), Cape Town

8005

Nordlandssykehuset ( Site 2041), Bodø

8011

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

9301

IATROS International ( Site 2204), Bloemfontein

10002

National Taiwan University Hospital ( Site 3100), Taipei

10029

Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042), New York

10126

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801), Turin

10787

Velocity Clinical Research GmbH Berlin ( Site 1503), Berlin

12203

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1534), Berlin

13057

Velocity Clinical Research, Syracuse ( Site 0014), East Syracuse

13620

Seoul National University Bundang Hospital ( Site 3005), Seongnam

14021

Institut Klinicke a Experimentalni Mediciny ( Site 3601), Prague

14080

Instituto Nacional de Ciencias Medicas y Nutricion Salvador -Unidad de Investigación de Enfermedade ( Site 1071), Mexico City

15001

Hospital Abente y Lago ( Site 2356), A Coruña

15006

Hospital San Rafael de Coruna ( Site 2363), A Coruña

15706

CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320), Santiago de Compostela

16499

Ajou University Hospital ( Site 3006), Suwon

16635

altoona center for clinical research ( Site 0024), Duncansville

17600

Hospital de Figueres ( Site 2361), Figueres

19067

Cardiology Consultants of Philadelphia Yardley ( Site 0021), Yardley

20009

Emerson Clinical Research Institute ( Site 0017), Washington D.C.

20110

Manassas Clinical Research Center ( Site 0007), Manassas

20138

Centro Cardiologico Monzino ( Site 1804), Milan

20854

Velocity Clinical Research Rockville ( Site 0022), Rockville

23294

National Clinical Research, Inc ( Site 0044), Richmond

23502

Alliance for Multispecialty Research, LLC ( Site 0008), Norfolk

23606

Health Research of Hampton Roads, Inc. ( Site 0019), Newport News

26426

Wonju Severance Christian Hospital ( Site 3008), Wŏnju

26480

Eskisehir Osmangazi University-Cardiology ( Site 2510), Eskişehir

28041

Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2311), Madrid

28223

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 2344), Pozuelo de Alarcón

28644

Chungbuk National University Hospital ( Site 3011), Cheongju-si

28922

Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316), Alcorcón

29010

Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2358), Málaga

29405

Coastal Carolina Research Center ( Site 0055), North Charleston

29621

Velocity Clinical Research, Anderson ( Site 0015), Anderson

29707

Piedmont Research Partners ( Site 0045), Fort Mill

31210

East Coast Institute for Research, LLC ( Site 0020), Macon

32127

Progressive Medical Research ( Site 0033), Port Orange

32216

Jacksonville Center for Clinical Research ( Site 0025), Jacksonville

32789

Clinical Site Partners, LLC dba Flourish Research ( Site 0004), Winter Park

33009

Velocity Clinical Research, Hallandale Beach ( Site 0053), Hallandale

33027

South Broward Research ( Site 0012), Miramar

33172

Alliance for Multispecialty Research, LLC ( Site 0037), Doral

33305

Chang Gung Medical Foundation-Linkou Branch ( Site 3105), Taoyuan District

33434

Excel Medical Clinical Trials ( Site 0010), Boca Raton

33607

Clinical Research Trials of Florida ( Site 0006), Tampa

33912

Alliance for Multispecialty Research, LLC ( Site 0056), Fort Myers

34090

Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 5002), Montpellier

35100

Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502), Bornova

36526

Alliance for Multispecialty Research, LLC ( Site 0027), Daphne

36535

G&L Research ( Site 0035), Foley

37660

Holston Medical Group ( Site 0034), Kingsport

37920

Alliance for Multispecialty Research, LLC ( Site 0050), Knoxville

38039

Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2522), Kayseri

39503

Velocity Clinical Research, Gulfport ( Site 0032), Gulfport

40213

L-MARC Research Center ( Site 0011), Louisville

40509

Alliance for Multispecialty Research, LLC ( Site 0001), Lexington

41009

Hospital Universitario Virgen Macarena-Cardiology ( Site 2352), Seville

41380

Kocaeli Üniversitesi-Cardiology ( Site 2516), Kocaeli

41950

Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349), Castilleja de la Cuesta

42601

Keimyung University Dongsan Hospital CRC room 1 ( Site 3003), Daegu

43204

Hospital Universitari Sant Joan de Reus ( Site 2329), Reus

44600

Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057), Guadalajara

44800

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 5004), Saint-Herblain

45359

Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1543), Essen

46010

HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321), Valencia

46260

Midwest Institute For Clinical Research ( Site 0052), Indianapolis

47714

Synexus Clinical Research US - Evansville ( Site 0005), Evansville

48098

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018), Troy

48108

Inje University Haeundae Paik Hospital ( Site 3010), Haeundae-gu

49201

Dong-A University Hospital-Cardiology ( Site 3013), Busan

49241

Pusan National University Hospital-Internal Medicine ( Site 3012), Busan

50006

Changhua Christian Hospital ( Site 3101), Changhua

57701

Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038), Rapid City

58104

Lillestol Research ( Site 0030), Fargo

60422

Healthcare Research Network - Chicago ( Site 0051), Flossmoor

61469

Chonnam National University Hospital ( Site 3014), Gwangju

63042

Healthcare Research Network - St. Louis ( Site 0040), Hazelwood

68510

Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031), Lincoln

69677

Hospices Civils de Lyon - Hopital Louis Pradel-Service d'endocrinologie, de diabétologie et des mal ( Site 5000), Bron

70433

Velocity Clinical Research, Covington ( Site 0026), Covington

71004

Chi Mei Medical Center ( Site 3104), Tainan City

75230

Velocity Clinical Research, Dallas ( Site 0028), Dallas

77030

Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0009), Houston

78229

Clinical Trials of Texas, LLC ( Site 0016), San Antonio

83301

Chang Gung Memorial Hospital at Kaohsiung ( Site 3102), Kaohsiung City

84088

Velocity Clinical Research, Salt Lake City ( Site 0041), West Jordan

84106

Synexus Clinical Research US, Inc. ( Site 0003), Salt Lake City

85020

Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048), Phoenix

87106

New Mexico Clinical Research & Osteoporosis Center ( Site 0043), Albuquerque

89106

Jubilee Clinical Research ( Site 0049), Las Vegas

89119

AB Clinical Trials ( Site 0002), Las Vegas

90211

National Heart Institute-Research ( Site 0029), Beverly Hills

92408

Velocity Clinical Research, Banning ( Site 0023), San Bernardino

95122

Azienda Ospedaliera Garibaldi ( Site 1810), Catania

95821

Clinical Trials Research ( Site 0054), Sacramento

98057

Rainier Clinical Research Center ( Site 0013), Renton

99437

Zentralklinik Bad Berka ( Site 1531), Bad Berka

100029

Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 6000), Beijing

100050

Beijing Friendship Hospital Affiliate of Capital University ( Site 6003), Beijing

110231

Salud SURA Calle 100 ( Site 0905), Bogotá

110301

Taipei Medical University Hospital ( Site 3108), Taipei

136000

Siping Central People's Hospital ( Site 6011), Siping

213000

Changzhou Second People's Hospital ( Site 6073), Changzhou

225001

Northern Jiangsu People s Hospital ( Site 6008), Yangzhou

250252

Healthy Medical Center S.A.S ( Site 0902), Zipaquirá

323000

Lishui City People s Hospital ( Site 6002), Lishui

330003

The Third Hospital of Nanchang - Fuhe ( Site 6078), Nanchang

400000

Hunan Provincial People's Hospital ( Site 6017), Changsha

400072

The Second Affiliated Hospital of Chongqing Medical University ( Site 6020), Chongqing

404100

Chongqing University Three Gorges Hospital ( Site 6021), Chongqing

430030

Wuhan Fourth Hospital ( Site 6056), Wuhan

434036

Jingzhou Central Hospital ( Site 6076), Jingzhou

510080

Guangdong Provincial People s Hospital ( Site 6004), Guangzhou

510280

Zhujiang Hospital ( Site 6029), Guangzhou

516001

Huizhou Municipal Central Hospital ( Site 6079), Huizhou

518053

The University of Hong Kong-Shenzhen Hospital ( Site 6018), Shenzhen

529889

Changi General Hospital ( Site 3211), Singapore

610021

Chengdu Second Municipal People's Hospital ( Site 6032), Chengdu

712000

Xianyang Hospital of Yan'an University ( Site 6040), Xianyang

760032

Fundación Valle del Lili ( Site 0903), Santiago de Cali

3081000

Clalit Health Services - Sakhnin Community Clinic ( Site 1730), Sakhnin

3109601

Rambam Health Care Campus ( Site 1739), Haifa

Rambam Health Care Campus ( Site 1742), Haifa

3810101

Hillel Yaffe Medical Center ( Site 1731), Hadera

4428164

Meir Medical Center. ( Site 1737), Kfar Saba

4941492

Rabin Medical Center ( Site 1738), Petah Tikva

Rabin Medical Center ( Site 1740), Petah Tikva

5110683

Clinical Research Chile SpA ( Site 0800), Valdivia

5265601

Sheba Medical Center ( Site 1733), Ramat Gan

7033001

Yitzhak Shamir Medical Center. ( Site 1736), Ẕerifin

7500859

CDIEM ( Site 0801), Providencia

8330034

Pontificia Universidad Catolica de Chile-CICUC ( Site 0803), Santiago

9103102

Shaare Zedek Medical Center ( Site 1735), Jerusalem

9112001

Hadassah Medical Center ( Site 1732), Jerusalem

Hadassah Medical Center ( Site 1741), Jerusalem

Hadassah Medical Center-Heart Institute ( Site 1734), Jerusalem

60430270

Universidade Federal Do Ceara ( Site 0702), Fortaleza

C1060ABN

CEDIC ( Site 0603), CABA

C1425AGC

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0605), CABA

B7600FZO

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602), Mar del Plata

B2800DGH

Instituto de Investigaciones Clinicas Zarate ( Site 0604), Zárate

S2000DEJ

Fundacion Estudios Clinicos ( Site 0601), Rosario

C1056ABI

Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607), CABA

C1061AAS

CIPREC ( Site 0600), CABA

C1426ABP

Fundación Respirar ( Site 0606), CABA

04012-909

Instituto Dante Pazzanese de Cardiology ( Site 0701), São Paulo

05403-900

Incor - Instituto do Coracao ( Site 0703), São Paulo

V7M 2H4

The Medical Arts Health Research Group ( Site 0506), North Vancouver

N1R 6V6

Cambridge Cardiac Care Centre ( Site 0502), Cambridge

M6B 3H7

North York Diagnostic and Cardiac Centre ( Site 0505), North York

G7H 7K9

Ecogene-21 ( Site 0500), Chicoutimi

H1T 1C8

Institut de Cardiologie de Montreal ( Site 0504), Montreal

G9A 4P3

Diex Recherche Trois-Rivieres ( Site 0503), Trois-Rivières

050021

Fundación Centro de Investigación Clínica CIC ( Site 0904), Medellín

08001

Ciensalud Ips S A S ( Site 0900), Barranquilla

080020

Clinica de la Costa S.A.S. ( Site 0901), Barranquilla

602 00

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

625 00

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

00290

Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300), Helsinki

01307

Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1510), Dresden

06679

Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1528), Hohenmölsen

Unknown

Queen Mary Hospital-Medical ( Site 3300), Hksar

Prince of Wales Hospital ( Site 3304), Shatin

00133

Fondazione Policlinico Tor Vergata ( Site 1809), Rome

00189

Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807), Rome

807-0857

Hirohata Naika Clinic ( Site 3513), Kitakyushu

311-0113

Nakakinen clinic ( Site 3510), Naka

300-1207

Noritake Clinic ( Site 3512), Ushiku

920-8650

National Hospital Organization Kanazawa Medical Center ( Site 3508), Kanazawa

020-0132

Hirano Medical Clinic ( Site 3522), Morioka

981-3133

Shirai Healthcare Clinic Izumichuou ( Site 3527), Sendai

598-8577

Rinku General Medical Center ( Site 3503), Izumisano

582-0005

Shiraiwa Medical Clinic ( Site 3514), Kashihara

565-0853

Medical Corporation Heishinkai OCROM Clinic ( Site 3501), Suita-shi

350-0495

Saitama Medical University Hospital ( Site 3506), Iruma

113-0033

Teramoto Medical and Dental Clinic ( Site 3507), Bunkyo-ku

103-0027

Tokyo-Eki Center-building Clinic ( Site 3505), Chuo-ku

104-0031

Fukuwa Clinic ( Site 3504), Chuo-ku

173-8606

Teikyo University Hospital ( Site 3500), Itabashi-ku

125-0054

Kato Clinic of Internal Medicine ( Site 3509), Katsushika-ku

181-0013

Kanno Naika ( Site 3511), Mitaka

177-0041

Sugawara Clinic ( Site 3519), Nerima-ku

144-0051

Shin Clinic ( Site 3517), Ōta-ku

160-0008

Medical Corporation Heishinkai ToCROM Clinic ( Site 3502), Shinjuku-ku

810-0001

Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520), Fukuoka

730-8518

Hiroshima City Hiroshima Citizens Hospital ( Site 3518), Hiroshima

153-0051

Mishuku Hospital ( Site 3524), Tokyo

160-0023

Mitsukoshi Health and Welfare Foundation ( Site 3521), Tokyo

6525 GA

Radboudumc-internal medicine ( Site 1952), Nijmegen

1105 AZ

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

1624 NP

Dijklander Ziekenhuis ( Site 1953), Hoorn

3584 CX

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

0316

Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2040), Oslo

03080

Seoul National University Hospital ( Site 3001), Seoul

03181

Kangbuk Samsung Hospital ( Site 3009), Seoul

03722

Severance Hospital, Yonsei University Health System ( Site 3002), Seoul

05505

Asan Medical Center ( Site 3004), Seoul

06351

Samsung Medical Center-cardiology ( Site 3000), Seoul

06591

The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007), Seoul

08540

EBA CENTELLES ( Site 2319), Centelles

08035

Hospital Universitari Vall d'Hebron ( Site 2362), Barcelona

08025

EAP Sardenya ( Site 2357), Barcelona

06230

Hacettepe Universite Hastaneleri ( Site 2500), Ankara

06800

Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501), Ankara

EC1M 6BQ

Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 4001), London

NW3 2QG

Royal Free Hospital ( Site 4000), London

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT06492291 - Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension | Biotech Hunter | Biotech Hunter