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NCT06492291Active, not recruitingPhase 3

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

A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia

Source: ClinicalTrials.gov · Last updated 7 Oct 2025

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
3000 (estimated)
First submitted
1 Jul 2024
Start date
5 Aug 2024
Primary completion date
13 Oct 2028
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT06492291
EU CT number
2023-504922-20-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 3000
  • From 5 Aug 2024 to the primary completion date, 13 Oct 2028
  • 222 sites in 28 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study

Other

  • 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 currently participating in an interventional clinical study other than an enlicitide decanoate parent study

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (222)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CEDIC ( Site 0603)
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CABAArgentinaUnknown status
Centro de Investigaciones Metabolicas CINME - Cardiology ( Site 0607)
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CABAArgentinaUnknown status
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0605)
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CABAArgentinaUnknown status
Fundación Respirar ( Site 0606)
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CABAArgentinaUnknown status
CIPREC ( Site 0600)
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CABAArgentinaUnknown status
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0602)
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Mar del PlataArgentinaUnknown status
Fundacion Estudios Clinicos ( Site 0601)
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RosarioArgentinaUnknown status
Instituto de Investigaciones Clinicas Zarate ( Site 0604)
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ZárateArgentinaUnknown status
Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
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CamperdownAustraliaUnknown status
Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)
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ClaytonAustraliaUnknown status
Universidade Federal Do Ceara ( Site 0702)
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FortalezaBrazilUnknown status
Incor - Instituto do Coracao ( Site 0703)
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São PauloBrazilUnknown status
Instituto Dante Pazzanese de Cardiology ( Site 0701)
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São PauloBrazilUnknown status
Cambridge Cardiac Care Centre ( Site 0502)
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CambridgeCanadaUnknown status
Ecogene-21 ( Site 0500)
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ChicoutimiCanadaUnknown status
Institut de Cardiologie de Montreal ( Site 0504)
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MontrealCanadaUnknown status
The Medical Arts Health Research Group ( Site 0506)
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North VancouverCanadaUnknown status
North York Diagnostic and Cardiac Centre ( Site 0505)
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North YorkCanadaUnknown status
Diex Recherche Trois-Rivieres ( Site 0503)
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Trois-RivièresCanadaUnknown status
CDIEM ( Site 0801)
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ProvidenciaChileUnknown status
Pontificia Universidad Catolica de Chile-CICUC ( Site 0803)
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SantiagoChileUnknown status
Clinical Research Chile SpA ( Site 0800)
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ValdiviaChileUnknown status
Beijing Friendship Hospital Affiliate of Capital University ( Site 6003)
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BeijingChinaUnknown status
Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 6000)
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BeijingChinaUnknown status
Hunan Provincial People's Hospital ( Site 6017)
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ChangshaChinaUnknown status
Changzhou Second People's Hospital ( Site 6073)
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ChangzhouChinaUnknown status
Chengdu Second Municipal People's Hospital ( Site 6032)
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ChengduChinaUnknown status
Chongqing University Three Gorges Hospital ( Site 6021)
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ChongqingChinaUnknown status
The Second Affiliated Hospital of Chongqing Medical University ( Site 6020)
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ChongqingChinaUnknown status
Zhujiang Hospital ( Site 6029)
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GuangzhouChinaUnknown status
Guangdong Provincial People s Hospital ( Site 6004)
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GuangzhouChinaUnknown status
Huizhou Municipal Central Hospital ( Site 6079)
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HuizhouChinaUnknown status
Jingzhou Central Hospital ( Site 6076)
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JingzhouChinaUnknown status
Lishui City People s Hospital ( Site 6002)
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LishuiChinaUnknown status
The Third Hospital of Nanchang - Fuhe ( Site 6078)
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NanchangChinaUnknown status
The University of Hong Kong-Shenzhen Hospital ( Site 6018)
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ShenzhenChinaUnknown status
Siping Central People's Hospital ( Site 6011)
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SipingChinaUnknown status
Wuhan Fourth Hospital ( Site 6056)
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WuhanChinaUnknown status
Xianyang Hospital of Yan'an University ( Site 6040)
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XianyangChinaUnknown status
Northern Jiangsu People s Hospital ( Site 6008)
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YangzhouChinaUnknown status
Clinica de la Costa S.A.S. ( Site 0901)
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BarranquillaColombiaUnknown status
Ciensalud Ips S A S ( Site 0900)
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BarranquillaColombiaUnknown status
Salud SURA Calle 100 ( Site 0905)
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BogotáColombiaUnknown status
Fundación Valle del Lili ( Site 0903)
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CaliColombiaUnknown status
Fundación Centro de Investigación Clínica CIC ( Site 0904)
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MedellínColombiaUnknown status
Healthy Medical Center S.A.S ( Site 0902)
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ZipaquiráColombiaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaActive, not recruiting
Institute for Clinical and Experimental Medicine
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PragueCzechiaActive, not recruiting
Zentralklinik Bad Berka GmbH
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Bad BerkaGermanyActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Velocity Clinical Research GmbH
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BerlinGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyActive, not recruiting
Uhz Klinische Forschung
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EssenGermanyActive, not recruiting
Hausarzt- und Diabetologischen Schwerpunktpraxis Hohenmölsen
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HohenmölsenGermanyActive, not recruiting
Instituto Medico Quirurgico San Rafael S.A.
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A CorunaSpainActive, not recruiting
Area Sanitaria Da Coruna E Cee
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A CorunaSpainActive, not recruiting
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Equip D'atencio Primaria Barcelona Sardenya S.L.P.
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BarcelonaSpainActive, not recruiting
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainActive, not recruiting
EAP Osona Sud - Alt Congost S.L.P
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CentellesSpainActive, not recruiting
Fundacio Salut Emporda
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FigueresSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Salut Sant Joan de Reus
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ReusSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
HUS-Yhtymae
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HelsinkiFinlandActive, not recruiting
Hospices Civils de Lyon
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BronFranceActive, not recruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceActive, not recruiting
Institut De Cancerologie De L Ouest
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St HerblainFranceActive, not recruiting
Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 4001)
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LondonUnited KingdomUnknown status
Royal Free Hospital ( Site 4000)
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LondonUnited KingdomUnknown status
Queen Mary Hospital-Medical ( Site 3300)
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HksarHong Kong SAR ChinaUnknown status
Prince of Wales Hospital ( Site 3304)
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ShatinHong Kong SAR ChinaUnknown status
Semmelweis University
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Budapest XIIHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
University of Szeged
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SzegedHungaryActive, not recruiting
Hillel Yaffe Medical Center ( Site 1731)
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HaderaIsraelUnknown status
Rambam Health Care Campus ( Site 1742)
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HaifaIsraelUnknown status
Rambam Health Care Campus ( Site 1739)
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HaifaIsraelUnknown status
Hadassah Medical Center ( Site 1732)
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JerusalemIsraelUnknown status
Hadassah Medical Center-Heart Institute ( Site 1734)
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JerusalemIsraelUnknown status
Hadassah Medical Center ( Site 1741)
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JerusalemIsraelUnknown status
Shaare Zedek Medical Center ( Site 1735)
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JerusalemIsraelUnknown status
Meir Medical Center. ( Site 1737)
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Kfar SabaIsraelUnknown status
Rabin Medical Center ( Site 1738)
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Petah TikvaIsraelUnknown status
Rabin Medical Center ( Site 1740)
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Petah TikvaIsraelUnknown status
Sheba Medical Center ( Site 1733)
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Ramat GanIsraelUnknown status
Clalit Health Services - Sakhnin Community Clinic ( Site 1730)
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SakhninIsraelUnknown status
Yitzhak Shamir Medical Center. ( Site 1736)
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TsrifinIsraelUnknown status
Centro Cardiologico Monzino S.p.A.
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MilanItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyActive, not recruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Teramoto Medical and Dental Clinic ( Site 3507)
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Bunkyo-kuJapanUnknown status
Fukuwa Clinic ( Site 3504)
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Chuo-kuJapanUnknown status
Tokyo-Eki Center-building Clinic ( Site 3505)
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Chuo-kuJapanUnknown status
Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
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FukuokaJapanUnknown status
Hiroshima City Hiroshima Citizens Hospital ( Site 3518)
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HiroshimaJapanUnknown status
Saitama Medical University Hospital ( Site 3506)
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IrumaJapanUnknown status
Rinku General Medical Center ( Site 3503)
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IzumisanoJapanUnknown status
National Hospital Organization Kanazawa Medical Center ( Site 3508)
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KanazawaJapanUnknown status
Shiraiwa Medical Clinic ( Site 3514)
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KashiharaJapanUnknown status
Kato Clinic of Internal Medicine ( Site 3509)
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Katsushika-kuJapanUnknown status
Hirohata Naika Clinic ( Site 3513)
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KitakyushuJapanUnknown status
Kanno Naika ( Site 3511)
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MitakaJapanUnknown status
Hirano Medical Clinic ( Site 3522)
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MoriokaJapanUnknown status
Nakakinen clinic ( Site 3510)
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NakaJapanUnknown status
Sugawara Clinic ( Site 3519)
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Nerima-kuJapanUnknown status
Shin Clinic ( Site 3517)
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Ōta-kuJapanUnknown status
Shirai Healthcare Clinic Izumichuou ( Site 3527)
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SendaiJapanUnknown status
Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
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Shinjuku-kuJapanUnknown status
Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
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Suita-shiJapanUnknown status
Teikyo University Hospital ( Site 3500)
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tabashi CityJapanUnknown status
Mishuku Hospital ( Site 3524)
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TokyoJapanUnknown status
Mitsukoshi Health and Welfare Foundation ( Site 3521)
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TokyoJapanUnknown status
Noritake Clinic ( Site 3512)
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UshikuJapanUnknown status
Pusan National University Hospital-Internal Medicine ( Site 3012)
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BusanSouth KoreaUnknown status
Dong-A University Hospital-Cardiology ( Site 3013)
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BusanSouth KoreaUnknown status
Chungbuk National University Hospital ( Site 3011)
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Cheongju-siSouth KoreaUnknown status
Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)
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DaeguSouth KoreaUnknown status
Chonnam National University Hospital ( Site 3014)
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GwangjuSouth KoreaUnknown status
Inje University Haeundae Paik Hospital ( Site 3010)
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Haeundae-guSouth KoreaUnknown status
Seoul National University Bundang Hospital ( Site 3005)
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SeongnamSouth KoreaUnknown status
Asan Medical Center ( Site 3004)
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital ( Site 3009)
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SeoulSouth KoreaUnknown status
Seoul National University Hospital ( Site 3001)
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SeoulSouth KoreaUnknown status
The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
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SeoulSouth KoreaUnknown status
Samsung Medical Center-cardiology ( Site 3000)
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System ( Site 3002)
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SeoulSouth KoreaUnknown status
Ajou University Hospital ( Site 3006)
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SuwonSouth KoreaUnknown status
Wonju Severance Christian Hospital ( Site 3008)
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WŏnjuSouth KoreaUnknown status
Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
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GuadalajaraMexicoUnknown status
Instituto Nacional de Ciencias Medicas y Nutricion Salvador -Unidad de Investigación de Enfermedade ( Site 1071)
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Mexico CityMexicoUnknown status
Amsterdam UMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Dijklander Ziekenhuis
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Hoorn NhNetherlandsActive, not recruiting
Stichting Radboud Universitair Medisch Centrum
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NijmegenNetherlandsActive, not recruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsActive, not recruiting
Nordlandssykehuset HF
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BodoNorwayActive, not recruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
New Zealand Clinical Research (Christchurch) ( Site 2901)
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ChristchurchNew ZealandUnknown status
Pacific Clinical Research Network - Rotorua ( Site 2902)
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RotoruaNew ZealandUnknown status
Changi General Hospital ( Site 3211)
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SingaporeSingaporeUnknown status
Changhua Christian Hospital ( Site 3101)
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ChanghuaTaiwanUnknown status
Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)
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Kaohsiung CityTaiwanUnknown status
Mackay Memorial Hospital -Tamsui Branch ( Site 3109)
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New Taipei CityTaiwanUnknown status
National Cheng Kung University Hospital-Internal Medicine ( Site 3107)
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TainanTaiwanUnknown status
Chi Mei Medical Center ( Site 3104)
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TainanTaiwanUnknown status
National Taiwan University Hospital ( Site 3100)
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TaipeiTaiwanUnknown status
Taipei Medical University Hospital ( Site 3108)
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital ( Site 3106)
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TaipeiTaiwanUnknown status
Shin Kong Wu Ho-Su Memorial Hospital ( Site 3110)
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Taipei CityTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch ( Site 3105)
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TaoyuanTaiwanUnknown status
New Mexico Clinical Research & Osteoporosis Center ( Site 0043)
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AlbuquerqueUnited StatesUnknown status
Velocity Clinical Research, Anderson ( Site 0015)
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AndersonUnited StatesUnknown status
National Heart Institute-Research ( Site 0029)
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Beverly HillsUnited StatesUnknown status
Excel Medical Clinical Trials ( Site 0010)
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Boca RatonUnited StatesUnknown status
Velocity Clinical Research, Covington ( Site 0026)
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CovingtonUnited StatesUnknown status
Velocity Clinical Research, Dallas ( Site 0028)
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DallasUnited StatesUnknown status
Alliance for Multispecialty Research, LLC ( Site 0027)
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DaphneUnited StatesUnknown status
Alliance for Multispecialty Research, LLC ( Site 0037)
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DoralUnited StatesUnknown status
altoona center for clinical research ( Site 0024)
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DuncansvilleUnited StatesUnknown status
Velocity Clinical Research, Syracuse ( Site 0014)
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East SyracuseUnited StatesUnknown status
Synexus Clinical Research US - Evansville ( Site 0005)
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EvansvilleUnited StatesUnknown status
Lillestol Research ( Site 0030)
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FargoUnited StatesUnknown status
Healthcare Research Network - Chicago ( Site 0051)
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FlossmoorUnited StatesUnknown status
G&L Research ( Site 0035)
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FoleyUnited StatesUnknown status
Piedmont Research Partners ( Site 0045)
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Fort MillUnited StatesUnknown status
Alliance for Multispecialty Research, LLC ( Site 0056)
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Fort MyersUnited StatesUnknown status
Velocity Clinical Research, Gulfport ( Site 0032)
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GulfportUnited StatesUnknown status
Velocity Clinical Research, Hallandale Beach ( Site 0053)
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HallandaleUnited StatesUnknown status
Healthcare Research Network - St. Louis ( Site 0040)
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HazelwoodUnited StatesUnknown status
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0009)
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HoustonUnited StatesUnknown status
Midwest Institute For Clinical Research ( Site 0052)
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IndianapolisUnited StatesUnknown status
Jacksonville Center for Clinical Research ( Site 0025)
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JacksonvilleUnited StatesUnknown status
Holston Medical Group ( Site 0034)
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KingsportUnited StatesUnknown status
Alliance for Multispecialty Research, LLC ( Site 0050)
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KnoxvilleUnited StatesUnknown status
AB Clinical Trials ( Site 0002)
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Las VegasUnited StatesUnknown status
Jubilee Clinical Research ( Site 0049)
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Las VegasUnited StatesUnknown status
Alliance for Multispecialty Research, LLC ( Site 0001)
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LexingtonUnited StatesUnknown status
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031)
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LincolnUnited StatesUnknown status
L-MARC Research Center ( Site 0011)
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LouisvilleUnited StatesUnknown status
East Coast Institute for Research, LLC ( Site 0020)
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MaconUnited StatesUnknown status
Manassas Clinical Research Center ( Site 0007)
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ManassasUnited StatesUnknown status
South Broward Research ( Site 0012)
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MiramarUnited StatesUnknown status
Health Research of Hampton Roads, Inc. ( Site 0019)
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Newport NewsUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0042)
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New YorkUnited StatesUnknown status
Alliance for Multispecialty Research, LLC ( Site 0008)
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NorfolkUnited StatesUnknown status
Coastal Carolina Research Center ( Site 0055)
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North CharlestonUnited StatesUnknown status
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)
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PhoenixUnited StatesUnknown status
Progressive Medical Research ( Site 0033)
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Port OrangeUnited StatesUnknown status
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0038)
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Rapid CityUnited StatesUnknown status
Rainier Clinical Research Center ( Site 0013)
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RentonUnited StatesUnknown status
National Clinical Research, Inc ( Site 0044)
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RichmondUnited StatesUnknown status
Velocity Clinical Research Rockville ( Site 0022)
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RockvilleUnited StatesUnknown status
Clinical Trials Research ( Site 0054)
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SacramentoUnited StatesUnknown status
Synexus Clinical Research US, Inc. ( Site 0003)
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Salt Lake CityUnited StatesUnknown status
Clinical Trials of Texas, LLC ( Site 0016)
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San AntonioUnited StatesUnknown status
Velocity Clinical Research, Banning ( Site 0023)
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San BernardinoUnited StatesUnknown status
Clinical Research Trials of Florida ( Site 0006)
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TampaUnited StatesUnknown status
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)
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TroyUnited StatesUnknown status
Emerson Clinical Research Institute ( Site 0017)
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Washington D.C.United StatesUnknown status
Velocity Clinical Research, Salt Lake City ( Site 0041)
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West JordanUnited StatesUnknown status
Clinical Site Partners, LLC dba Flourish Research ( Site 0004)
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Winter ParkUnited StatesUnknown status
Cardiology Consultants of Philadelphia Yardley ( Site 0021)
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YardleyUnited StatesUnknown status
IATROS International ( Site 2204)
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BloemfonteinSouth AfricaUnknown status
TREAD Research ( Site 2201)
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Cape TownSouth AfricaUnknown status
Tiervlei Trial Centre ( Site 2205)
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Cape TownSouth AfricaUnknown status
University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2200)
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Cape TownSouth AfricaUnknown status
Charlotte Maxeke Johannesburg Academic Hospital ( Site 2202)
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JohannesburgSouth AfricaUnknown status
Soweto Clinical Trials Centre ( Site 2203)
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SowetoSouth AfricaUnknown status
Hacettepe Universite Hastaneleri ( Site 2500)
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
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AnkaraTurkey (Türkiye)Unknown status
Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
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BornovaTurkey (Türkiye)Unknown status
Eskisehir Osmangazi University-Cardiology ( Site 2510)
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EskişehirTurkey (Türkiye)Unknown status
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 2522)
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KayseriTurkey (Türkiye)Unknown status
Kocaeli Üniversitesi-Cardiology ( Site 2516)
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KocaeliTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.