Clinical trial NCT06492291: Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
Official title: A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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)
* Had an overall study intervention compliance ≥80% while participating in their parent study

Exclusion Criteria:

* Has discontinued study intervention in their parent study
* Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
* Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
* Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study

Primary outcomes:
measure: Number of participants with one or more adverse events (AEs)
timeFrame: Up to approximately 3 years
measure: Number of participants who discontinue study drug due to an AE
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study
timeFrame: Baseline of the parent study and Week 8 of this extension study
measure: Mean percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this Extension Study
timeFrame: Baseline of the parent study and Week 8 of this extension study
measure: Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study
timeFrame: Baseline of the parent study and Week 8 of this extension study
measure: Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study
timeFrame: Baseline of the parent study and Week 8 of this extension study
measure: Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study
timeFrame: Baseline in the parent study and up to approximately 3 years in this extension study
measure: Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study
timeFrame: Baseline in the parent study and up to approximately 3 years in this extension study
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0027)
state: Alabama
city: Foley
country: United States
facility: G&L Research ( Site 0035)
state: Alabama
city: Phoenix
country: United States
facility: Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)
state: Arizona
city: Beverly Hills
country: United States
facility: National Heart Institute-Research ( Site 0029)
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research ( Site 0054)
state: California
city: San Bernardino
country: United States
facility: Velocity Clinical Research, Banning ( Site 0023)
state: California
city: Washington
country: United States
facility: Emerson Clinical Research Institute ( Site 0017)
state: District of Columbia
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials ( Site 0010)
state: Florida
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0037)
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0056)
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0053)
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research ( Site 0025)
state: Florida
city: Miramar
country: United States
facility: South Broward Research ( Site 0012)
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research ( Site 0033)
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida ( Site 0006)
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research ( Site 0004)
state: Florida
city: Macon
country: United States
facility: East Coast Institute for Research, LLC ( Site 0020)
state: Georgia
city: Flossmoor
country: United States
facility: Healthcare Research Network - Chicago ( Site 0051)
state: Illinois
city: Evansville
country: United States
facility: Synexus Clinical Research US - Evansville ( Site 0005)
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Institute For Clinical Research ( Site 0052)
state: Indiana
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0001)
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center ( Site 0011)
state: Kentucky
city: Covington
country: United States
facility: Velocity Clinical Research, Covington ( Site 0026)
state: Louisiana
city: Rockville
country: United States
facility: Velocity Clinical Research Rockville ( Site 0022)
state: Maryland
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)
state: Michigan
city: Gulfport
country: United States
facility: Velocity Clinical Research, Gulfport ( Site 0032)
state: Mississippi
city: Hazelwood
country: United States
facility: Healthcare Research Network - St. Louis ( Site 0040)
state: Missouri
city: Lincoln
country: United States
facility: Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031)
state: Nebraska
city: Las Vegas
country: United States
facility: Jubilee Clinical Research ( Site 0049)
state: Nevada
city: Las Vegas
country: United States
facility: AB Clinical Trials ( Site 0002)
state: Nevada
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center ( Site 0043)
state: New Mexico
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse ( Site 0014)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042)
state: New York
city: Fargo
country: United States
facility: Lillestol Research ( Site 0030)
state: North Dakota
city: Duncansville
country: United States
facility: altoona center for clinical research ( Site 0024)
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia Yardley ( Site 0021)
state: Pennsylvania
city: Anderson
country: United States
facility: Velocity Clinical Research, Anderson ( Site 0015)
state: South Carolina
city: Fort Mill
country: United States
facility: Piedmont Research Partners ( Site 0045)
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center ( Site 0055)
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038)
state: South Dakota
city: Kingsport
country: United States
facility: Holston Medical Group ( Site 0034)
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0050)
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas ( Site 0028)
state: Texas
city: Houston
country: United States
facility: Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0009)
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC ( Site 0016)
state: Texas
city: Salt Lake City
country: United States
facility: Synexus Clinical Research US, Inc. ( Site 0003)
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City ( Site 0041)
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center ( Site 0007)
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. ( Site 0019)
state: Virginia
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0008)
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc ( Site 0044)
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center ( Site 0013)
state: Washington
city: Caba
country: Argentina
facility: CEDIC ( Site 0603)
state: Buenos Aires
city: Caba
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0605)
state: Buenos Aires
city: Caba
country: Argentina
facility: Fundación Respirar ( Site 0606)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602)
state: Buenos Aires
city: Zárate
country: Argentina
facility: Instituto de Investigaciones Clinicas Zarate ( Site 0604)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos ( Site 0601)
state: Santa Fe
city: Caba
country: Argentina
facility: Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607)
city: Caba
country: Argentina
facility: CIPREC ( Site 0600)
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
state: New South Wales
city: Clayton
country: Australia
facility: Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)
state: Victoria
city: Fortaleza
country: Brazil
facility: Universidade Federal Do Ceara ( Site 0702)
state: Ceara
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiology ( Site 0701)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Incor - Instituto do Coracao ( Site 0703)
city: North Vancouver
country: Canada
facility: The Medical Arts Health Research Group ( Site 0506)
state: British Columbia
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Centre ( Site 0502)
state: Ontario
city: North York
country: Canada
facility: North York Diagnostic and Cardiac Centre ( Site 0505)
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21 ( Site 0500)
state: Quebec
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal ( Site 0504)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Diex Recherche Trois-Rivieres ( Site 0503)
state: Quebec
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA ( Site 0800)
state: Los Rios
city: Providencia
country: Chile
facility: CDIEM ( Site 0801)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-CICUC ( Site 0803)
state: Region M. De Santiago
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 6000)
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliate of Capital University ( Site 6003)
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University ( Site 6020)
state: Chongqing
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital ( Site 6021)
state: Chongqing
city: Guangzhou
country: China
facility: Guangdong Provincial People s Hospital ( Site 6004)
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital ( Site 6029)
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital ( Site 6079)
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong-Shenzhen Hospital ( Site 6018)
state: Guangdong
city: Jingzhou
country: China
facility: Jingzhou Central Hospital ( Site 6076)
state: Hubei
city: Wuhan
country: China
facility: Wuhan Fourth Hospital ( Site 6056)
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital ( Site 6017)
state: Hunan
city: Changzhou
country: China
facility: Changzhou Second People's Hospital ( Site 6073)
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People s Hospital ( Site 6008)
state: Jiangsu
city: Nanchang
country: China
facility: The Third Hospital of Nanchang - Fuhe ( Site 6078)
state: Jiangxi
city: Siping
country: China
facility: Siping Central People's Hospital ( Site 6011)
state: Jilin
city: Xianyang City
country: China
facility: Xianyang Hospital of Yan'an University ( Site 6040)
state: Shaanxi
city: Chengdu
country: China
facility: Chengdu Second Municipal People's Hospital ( Site 6032)
state: Sichuan
city: Lishui
country: China
facility: Lishui City People s Hospital ( Site 6002)
state: Zhejiang
city: Medellín
country: Colombia
facility: Fundación Centro de Investigación Clínica CIC ( Site 0904)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Ciensalud Ips S A S ( Site 0900)
state: Atlantico
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 0901)
state: Atlantico
city: Bogotá
country: Colombia
facility: Salud SURA Calle 100 ( Site 0905)
state: Cundinamarca
city: Zipaquira
country: Colombia
facility: Healthy Medical Center S.A.S ( Site 0902)
state: Cundinamarca
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0903)
state: Valle Del Cauca
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)
state: Brno-mesto
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)
state: Brno-mesto
city: Prague
country: Czechia
facility: Institut Klinicke a Experimentalni Mediciny ( Site 3601)
state: Praha 4
city: Helsinki
country: Finland
facility: Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)
state: Uusimaa
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 5002)
state: Herault
city: Saint-Herblain
country: France
facility: Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 5004)
state: Loire-Atlantique
city: Bron
country: France
facility: Hospices Civils de Lyon - Hopital Louis Pradel-Service d'endocrinologie, de diabétologie et des mal ( Site 5000)
state: Rhone
city: Essen
country: Germany
facility: Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1543)
state: Nordrhein-Westfalen
city: Hohenmoelsen
country: Germany
facility: Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1528)
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1510)
state: Sachsen
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka ( Site 1531)
state: Thuringen
city: Berlin
country: Germany
facility: Velocity Clinical Research GmbH Berlin ( Site 1503)
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1534)
city: Hksar
country: Hong Kong
facility: Queen Mary Hospital-Medical ( Site 3300)
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 3304)
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)
state: Csongrad
city: Budapest
country: Hungary
facility: Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center ( Site 1731)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 1739)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 1742)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1735)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1732)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1741)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Heart Institute ( Site 1734)
city: Kfar Saba
country: Israel
facility: Meir Medical Center. ( Site 1737)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1738)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1740)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 1733)
city: Sakhnin
country: Israel
facility: Clalit Health Services - Sakhnin Community Clinic ( Site 1730)
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center. ( Site 1736)
city: Rome
country: Italy
facility: Fondazione Policlinico Tor Vergata ( Site 1809)
state: Lazio
city: Milan
country: Italy
facility: Centro Cardiologico Monzino ( Site 1804)
state: Milano
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)
state: Piemonte
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)
state: Roma
city: Catania
country: Italy
facility: Azienda Ospedaliera Garibaldi ( Site 1810)
city: Kitakyushu
country: Japan
facility: Hirohata Naika Clinic ( Site 3513)
state: Fukuoka
city: Naka
country: Japan
facility: Nakakinen clinic ( Site 3510)
state: Ibaraki
city: Ushiku
country: Japan
facility: Noritake Clinic ( Site 3512)
state: Ibaraki
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center ( Site 3508)
state: Ishikawa
city: Morioka
country: Japan
facility: Hirano Medical Clinic ( Site 3522)
state: Iwate
city: Sendai
country: Japan
facility: Shirai Healthcare Clinic Izumichuou ( Site 3527)
state: Miyagi
city: Izumisano
country: Japan
facility: Rinku General Medical Center ( Site 3503)
state: Osaka
city: Kashiwara
country: Japan
facility: Shiraiwa Medical Clinic ( Site 3514)
state: Osaka
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
state: Osaka
city: Iruma
country: Japan
facility: Saitama Medical University Hospital ( Site 3506)
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Teramoto Medical and Dental Clinic ( Site 3507)
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic ( Site 3505)
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic ( Site 3504)
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital ( Site 3500)
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Kato Clinic of Internal Medicine ( Site 3509)
state: Tokyo
city: Mitaka
country: Japan
facility: Kanno Naika ( Site 3511)
state: Tokyo
city: Nerima-ku
country: Japan
facility: Sugawara Clinic ( Site 3519)
state: Tokyo
city: Ota-ku
country: Japan
facility: Shin Clinic ( Site 3517)
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
state: Tokyo
city: Fukuoka
country: Japan
facility: Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 3518)
city: Tokyo
country: Japan
facility: Mishuku Hospital ( Site 3524)
city: Tokyo
country: Japan
facility: Mitsukoshi Health and Welfare Foundation ( Site 3521)
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital ( Site 3011)
state: Chungbuk
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital ( Site 3008)
state: Kang-won-do
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital ( Site 3014)
state: Kwangju-Kwangyokshi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 3005)
state: Kyonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital ( Site 3006)
state: Kyonggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital-Cardiology ( Site 3013)
state: Pusan-Kwangyokshi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital-Internal Medicine ( Site 3012)
state: Pusan-Kwangyokshi
city: Haeundae-gu
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital ( Site 3010)
state: Pusan-Kwangyokshi
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 3001)
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital ( Site 3009)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 3002)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 3004)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-cardiology ( Site 3000)
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador -Unidad de Investigación de Enfermedade ( Site 1071)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
state: Jalisco
city: Nijmegen
country: Netherlands
facility: Radboudumc-internal medicine ( Site 1952)
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)
state: Noord-Holland
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis ( Site 1953)
state: Noord-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)
city: Rotorua
country: New Zealand
facility: Pacific Clinical Research Network - Rotorua ( Site 2902)
state: Bay Of Plenty
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research (Christchurch) ( Site 2901)
state: Canterbury
city: Bodø
country: Norway
facility: Nordlandssykehuset ( Site 2041)
state: Nordland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2040)
city: Singapore
country: Singapore
facility: Changi General Hospital ( Site 3211)
state: Central Singapore
city: Bloemfontein
country: South Africa
facility: IATROS International ( Site 2204)
state: Free State
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital ( Site 2202)
state: Gauteng
city: Soweto
country: South Africa
facility: Soweto Clinical Trials Centre ( Site 2203)
state: Gauteng
city: Cape Town
country: South Africa
facility: TREAD Research ( Site 2201)
state: Western Cape
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre ( Site 2205)
state: Western Cape
city: Cape Town
country: South Africa
facility: University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2200)
state: Western Cape
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2358)
state: Andalucia
city: Centelles
country: Spain
facility: EBA CENTELLES ( Site 2319)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron ( Site 2362)
state: Cataluna
city: Figueres
country: Spain
facility: Hospital de Figueres ( Site 2361)
state: Gerona
city: A Coruña
country: Spain
facility: Hospital Abente y Lago ( Site 2356)
state: La Coruna
city: A Coruña
country: Spain
facility: Hospital San Rafael de Coruna ( Site 2363)
state: La Coruna
city: Santiago de compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)
state: La Coruna
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)
state: Madrid, Comunidad De
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 2344)
state: Madrid
city: Castilleja de la Cuesta
country: Spain
facility: Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)
state: Sevilla
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus ( Site 2329)
state: Tarragona
city: Valencia
country: Spain
facility: HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: EAP Sardenya ( Site 2357)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2311)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena-Cardiology ( Site 2352)
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
state: Kaohsiung
city: New Taipei City
country: Taiwan
facility: Mackay Memorial Hospital -Tamsui Branch ( Site 3109)
state: New Taipei
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center ( Site 3104)
state: Tainan
city: Taipei City
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital ( Site 3110)
state: Taipei
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital ( Site 3101)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Internal Medicine ( Site 3107)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 3100)
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital ( Site 3108)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 3106)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 3105)
city: Bornova
country: Turkey
facility: Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
state: Izmir
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri ( Site 2500)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University-Cardiology ( Site 2510)
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2522)
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi-Cardiology ( Site 2516)
city: London
country: United Kingdom
facility: Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 4001)
state: England
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 4000)
state: England
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: