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NCT05877547CompletedPhase 2

A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis

Source: ClinicalTrials.gov · Last updated 12 Jan 2026

Brief summary (registry, in English)

The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
381 (actual)
First submitted
17 May 2023
Start date
23 Jun 2023
Primary completion date
29 Dec 2025
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05877547
EU CT number
2022-502647-35-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 381
  • From 23 Jun 2023 to the primary completion date, 29 Dec 2025
  • 173 sites in 26 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

  • Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack

Other illness

  • History of liver disease other than NASH
  • History of pancreatitis
  • History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy

Age

  • History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality

Other

  • History or evidence of cirrhosis

Who the study is looking for

  • Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
  • No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
  • Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (173)

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

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaCompleted
Klinik Landstrabe
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ViennaAustriaCompleted
Antwerp University Hospital
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EdegemBelgiumCompleted
Az Maria Middelares Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Heritage Medical Research Clinic ( Site 0403)
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CalgaryCanadaUnknown status
McGill University Health Centre ( Site 0400)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Diex Recherche Quebec Inc. ( Site 0409)
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QuébecCanadaUnknown status
Toronto General Hospital ( Site 0402)
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Vancouver General Hospital-Gastroenterology ( Site 0408)
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
Fondazione Epatocentro Ticino ( Site 2602)
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LuganoSwitzerlandUnknown status
Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601)
Coordinator of this site? Confirm its status
Sankt GallenSwitzerlandUnknown status
UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603)
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status
Enroll SpA ( Site 0501)
Coordinator of this site? Confirm its status
ProvidenciaChileUnknown status
Pontificia Universidad Catolica de Chile-CICUC ( Site 0502)
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SantiagoChileUnknown status
CECIM ( Site 0500)
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SantiagoChileUnknown status
Beijing Youan Hospital ( Site 0602)
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BeijingChinaUnknown status
Beijing Tsinghua Changgung Hospital ( Site 0606)
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BeijingChinaUnknown status
West China Hospital, Sichuan University ( Site 0611)
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ChengduChinaUnknown status
Southern Medical University Nanfang Hospital ( Site 0601)
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University ( Site 0603)
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GuangzhouChinaUnknown status
No. 2 Hospital of Nanjing ( Site 0605)
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NanjingChinaUnknown status
Tianjin Second People's Hospital ( Site 0604)
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TianjinChinaUnknown status
Chongqing University Three Gorges Hospital ( Site 0607)
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WanzhouChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University ( Site 0609)
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WenzhouChinaUnknown status
Fundacion Santa Fe de Bogota ( Site 0701)
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BogotáColombiaUnknown status
Solano & Terront Servicios Medicos - UNIENDO ( Site 0705)
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BogotáColombiaUnknown status
Fundación Valle del Lili ( Site 0700)
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CaliColombiaUnknown status
Fundación Centro de Investigación Clínica CIC ( Site 0704)
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MedellínColombiaUnknown status
Oncomédica S.A.S ( Site 0702)
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MonteríaColombiaUnknown status
Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0708)
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ValleduparColombiaUnknown status
Krajska nemocnice Liberec a.s.
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Liberec I-Stare MestoCzechiaCompleted
Klin Med s.r.o.
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Prague 2CzechiaCompleted
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital General De Tomelloso
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TomellosoSpainCompleted
Hospital Unviersitario Miguel Servet
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ZaragozaSpainCompleted
Hopital De La Croix-Rousse
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Lyon Cedex 04FranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
CHU De Rouen
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Rouen CedexFranceCompleted
Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004)
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AberdeenUnited KingdomUnknown status
Queen Elizabeth Hospital Birmingham ( Site 3000)
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BirminghamUnited KingdomUnknown status
St James's University Hospital ( Site 3005)
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LeedsUnited KingdomUnknown status
Royal London Hospital ( Site 3003)
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LondonUnited KingdomUnknown status
King's College Hospital ( Site 3002)
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LondonUnited KingdomUnknown status
Prince of Wales Hospital ( Site 1000)
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ShatinHong Kong SAR ChinaUnknown status
SYNEXUS Magyarorszag Kft.
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Budapest IIIHungaryCompleted
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
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Budapest IXHungaryCompleted
Barzilai Medical Center ( Site 1306)
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AshkelonIsraelUnknown status
Carmel Hospital ( Site 1305)
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HaifaIsraelUnknown status
Rambam Health Care Campus ( Site 1304)
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HaifaIsraelUnknown status
Shaare Zedek Medical Center-Liver Unit ( Site 1302)
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JerusalemIsraelUnknown status
Rabin Medical Center ( Site 1301)
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Petah TikvaIsraelUnknown status
Sheba Medical Center ( Site 1300)
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Ramat GanIsraelUnknown status
Maccabi Health Services - Ramat Hasharon ( Site 1303)
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Ramat HaSharonIsraelUnknown status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyCompleted
Fukuiken Saiseikai Hospital ( Site 1507)
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FukuiJapanUnknown status
Gifu Municipal Hospital ( Site 1506)
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GifuJapanUnknown status
Nara Medical University Hospital ( Site 1513)
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KashiharaJapanUnknown status
St. Marianna University Hospital ( Site 1516)
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KawasakiJapanUnknown status
Toranomon Hospital Kajigaya ( Site 1502)
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KawasakiJapanUnknown status
Shinyurigaoka General Hospital ( Site 1518)
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KawasakiJapanUnknown status
Kagawa University Hospital ( Site 1515)
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KitaJapanUnknown status
Kurume University Hospital ( Site 1504)
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KurumeJapanUnknown status
University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)
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KyotoJapanUnknown status
Shinshu University Hospital ( Site 1512)
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MatsumotoJapanUnknown status
Toranomon Hospital ( Site 1501)
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Minato-kuJapanUnknown status
Ogaki Municipal Hospital ( Site 1511)
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ŌgakiJapanUnknown status
Kawasaki Medical School General Medical Center ( Site 1508)
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OkayamaJapanUnknown status
Osaka Metropolitan University Hospital ( Site 1520)
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OsakaJapanUnknown status
Saga University Hospital ( Site 1510)
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SagaJapanUnknown status
Sapporo Kosei General Hospital ( Site 1521)
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SapporoJapanUnknown status
Osaka Saiseikai Suita Hospital ( Site 1503)
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SuitaJapanUnknown status
Kagawa Prefectural Central Hospital ( Site 1514)
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TakamatsuJapanUnknown status
Japanese Red Cross Musashino Hospital ( Site 1517)
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TokyoJapanUnknown status
Ehime University Hospital ( Site 1509)
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TōonJapanUnknown status
Yokohama City University Hospital ( Site 1505)
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YokohamaJapanUnknown status
Boramae Medical Center-Internal Medicine ( Site 2403)
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Dongjak-guSouth KoreaUnknown status
Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)
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IncheonSouth KoreaUnknown status
Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System ( Site 2401)
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SeoulSouth KoreaUnknown status
ICARO Investigaciones en Medicina ( Site 1608)
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Chihuahua CityMexicoUnknown status
Centro de Investigación y Gastroenterología ( Site 1601)
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CuauhtémocMexicoUnknown status
Centro de Investigación y Gastroenterología - S.C. ( Site 1609)
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Mexico CityMexicoUnknown status
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1603)
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Mexico CityMexicoUnknown status
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1604)
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MonterreyMexicoUnknown status
Servicios de Oncología Médica Integral - Monterrey ( Site 1611)
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MonterreyMexicoUnknown status
Oaxaca Site Management Organization ( Site 1613)
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Oaxaca CityMexicoUnknown status
Centro de Investigacion Clinica de Oaxaca ( Site 1607)
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Oaxaca CityMexicoUnknown status
CLINICA DELGADO-Clinical Research ( Site 1800)
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MirafloresPeruUnknown status
Instituto Médico Soy Diabetico ( Site 1804)
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PiuraPeruUnknown status
Centro de investigacion Clínica Trujillo ( Site 1802)
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TrujilloPeruUnknown status
ISIS CLINICAL RESEARCH CENTER ( Site 2006)
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GuaynaboPuerto RicoUnknown status
Pan American Center for Oncology Trials ( Site 2000)
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Rio PiedrasPuerto RicoUnknown status
Klinical Investigations Group-Clinical Research ( Site 2001)
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San JuanPuerto RicoUnknown status
Latin Clinical Trial Center ( Site 2004)
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San JuanPuerto RicoUnknown status
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalCompleted
Unidade Local De Saude Lisboa Ocidental E.P.E.
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LisbonPortugalCompleted
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalCompleted
Unidade Local De Saude Do Alto Minho E.P.E.
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Viana do CasteloPortugalCompleted
Singapore General Hospital ( Site 2188)
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SingaporeSingaporeUnknown status
Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 2802)
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BangkokThailandUnknown status
Chulalongkorn University ( Site 2800)
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BangkokThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital ( Site 2801)
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MuangThailandUnknown status
Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)
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Changhua CountyTaiwanUnknown status
Chiayi Christian Hospital ( Site 2707)
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Chiayi CityTaiwanUnknown status
Taichung Veterans General Hospital ( Site 2703)
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi
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TainanTaiwanUnknown status
Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
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TaipeiTaiwanUnknown status
National Taiwan University Hospital-Internal Medicine ( Site 2700)
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch ( Site 2702)
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TaoyuanTaiwanUnknown status
Om Research - Apple Valley ( Site 3244)
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Apple ValleyUnited StatesUnknown status
Velocity Clinical Research, Austin ( Site 3235)
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AustinUnited StatesUnknown status
Excel Medical Clinical Trials ( Site 3246)
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Boca RatonUnited StatesUnknown status
Synergy Healthcare ( Site 3286)
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BradentonUnited StatesUnknown status
Synergy Healthcare LLC ( Site 3290)
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BrandonUnited StatesUnknown status
South Texas Research Institute - Brownsville ( Site 3285)
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BrownsvilleUnited StatesUnknown status
Om Research LLC ( Site 3245)
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CamarilloUnited StatesUnknown status
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3
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ChandlerUnited StatesUnknown status
Eagle Clinical Research ( Site 3233)
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ChicagoUnited StatesUnknown status
Velocity Clinical Research, Cincinnati ( Site 3237)
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CincinnatiUnited StatesUnknown status
Top Medical Research ( Site 3209)
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Cutler BayUnited StatesUnknown status
Velocity Clinical Research, Dallas ( Site 3220)
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DallasUnited StatesUnknown status
Southeast Clinical Research Center ( Site 3288)
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DaltonUnited StatesUnknown status
Velocity Clinical Research, Providence ( Site 3222)
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East GreenwichUnited StatesUnknown status
Velocity Clinical Research, Syracuse ( Site 3227)
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East SyracuseUnited StatesUnknown status
Covenant Metabolic Specialists, LLC ( Site 3231)
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Fort MyersUnited StatesUnknown status
Velocity Clinical Research, Gardena ( Site 3225)
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GardenaUnited StatesUnknown status
Velocity Clinical Research, Hallandale Beach ( Site 3241)
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HallandaleUnited StatesUnknown status
Sweet Hope Research Specialty, Inc-Research ( Site 3200)
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HialeahUnited StatesUnknown status
Indago Research & Health Center, Inc ( Site 3207)
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HialeahUnited StatesUnknown status
Houston Research Institute ( Site 3262)
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HoustonUnited StatesUnknown status
Velocity Clinical Research, Huntington Park ( Site 3217)
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Huntington ParkUnited StatesUnknown status
University of Iowa ( Site 3213)
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Iowa CityUnited StatesUnknown status
Kansas City Research Institute ( Site 3249)
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Kansas CityUnited StatesUnknown status
Florida Research Institute ( Site 3243)
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Lakewood RchUnited StatesUnknown status
Velocity Clinical Research, San Diego ( Site 3226)
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La MesaUnited StatesUnknown status
Om Research LLC ( Site 3229)
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LancasterUnited StatesUnknown status
The Machuca Foundation ( Site 3234)
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Las VegasUnited StatesUnknown status
Velocity Clinical Research, Westlake ( Site 3216)
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Los AngelesUnited StatesUnknown status
Genoma Research Group ( Site 3242)
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MiamiUnited StatesUnknown status
Floridian Clinical Research, LLC ( Site 3203)
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Miami LakesUnited StatesUnknown status
New York Gastroenterology Associates ( Site 3252)
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New YorkUnited StatesUnknown status
Velocity Clinical Research, Panorama City ( Site 3214)
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Panorama CityUnited StatesUnknown status
California Liver Research Institute ( Site 3232)
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PasadenaUnited StatesUnknown status
The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)
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PeoriaUnited StatesUnknown status
Gastroenterology Consultants of Southwest Virginia ( Site 3282)
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RoanokeUnited StatesUnknown status
Clinical Trials Research ( Site 3230)
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SacramentoUnited StatesUnknown status
Pinnacle Clinical Research ( Site 3284)
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San AntonioUnited StatesUnknown status
American Research Corporation ( Site 3202)
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San AntonioUnited StatesUnknown status
Del Sol Research Management, LLC ( Site 3211)
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TucsonUnited StatesUnknown status
The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)
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TucsonUnited StatesUnknown status
Velocity Clinical Research, Salt Lake City ( Site 3223)
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West JordanUnited StatesUnknown status
Hacettepe Universite Hastaneleri-internal diseases ( Site 2901)
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AnkaraTurkey (Türkiye)Unknown status
Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903)
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IstanbulTurkey (Türkiye)Unknown status
T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik -T.C. Sağlik Bakanliği- Marmara Ünivers
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IstanbulTurkey (Türkiye)Unknown status
Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905)
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IzmirTurkey (Türkiye)Unknown status
Recep Tayyip Erdogan University Training and Research Hospital ( Site 2900)
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RizeTurkey (Türkiye)Unknown status

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