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NCT07221188RecruitingPhase 3

A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Brief summary (registry, in English)

This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1250 (estimated)
First submitted
15 Oct 2025
Start date
12 Dec 2025
Primary completion date
24 Mar 2028
Lead sponsor
GlaxoSmithKline
NCT number
NCT07221188
EU CT number
2025-523674-16-00
EudraCT number
2025-523674-16

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1250
  • From 12 Dec 2025 to the primary completion date, 24 Mar 2028
  • 154 sites in 16 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

  • Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis, or any history or evidence of cirrhosis; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
  • Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening

Other illness

  • Model for End-Stage Liver Disease (MELD) 3.0 score \>=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome)
  • Known co-infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus; c. Hepatitis C virus (HCV); d. Hepatitis D virus; or e. Hepatitis E virus.

Lab values

  • ALT or AST \>=5 × upper limit of normal (ULN)
  • Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \>=1.3 mg/dL and direct BILI is \<=20% of total BILI; otherwise, the individual will be excluded.
  • Serum albumin \<=3.5 grams per deciliter (g/dL)
  • International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
  • Alkaline phosphatase (ALP) \>=2 × ULN
  • Platelet (PLT) count \<140 000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor
  • Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.
  • HbA1c \>=9.0%

Other

  • Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL)
  • Phosphatidylethanol (PEth) \>=80 nanogram per milliliter (ng/mL) at Screening

Who the study is looking for

  • Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
  • Age \>=18 through \<=75 years at enrolment
  • History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
  • History or presence of known or suspected MASH with evidence of fibrosis

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (154)

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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GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
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Klagenfurt Am WoertherseeAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Klinik Hietzing
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ViennaAustriaRecruiting
GSK Investigational Site
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WoolloongabbaAustraliaRecruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Az Maria Middelares Gent
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GentBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
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Gorna OryahovitsaBulgariaRecruiting
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
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PanagyurishteBulgariaRecruiting
Medical Centre Futuremeds EOOD
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PlovdivBulgariaRecruiting
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
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PlovdivBulgariaRecruiting
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
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SlivenBulgariaRecruiting
Diagnostic Consultative Centre Ascendent EOOD
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SofiaBulgariaRecruiting
University Hospital Lozenetz
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SofiaBulgariaRecruiting
Military Medical Academy
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SofiyaBulgariaRecruiting
Acibadem City Clinic Tokuda University Hospital EAD
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SofiyaBulgariaRecruiting
Medical Center Hera EOOD
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SofiyaBulgariaRecruiting
Multispecialty hospital for active treatment Sveta Sofia EOOD
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SofiyaBulgariaRecruiting
Diagnostic-Consultative Center Alexandrovska EOOD
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SofiyaBulgariaRecruiting
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
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SofiyaBulgariaRecruiting
MBAL Trakia EOOD
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Stara ZagoraBulgariaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
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BerlinGermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Universitaet Des Saarlandes
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HomburgGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Eugastro GmbH
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LeipzigGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
Universitaet Muenster
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MuensterGermanyRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainRecruiting
Hospital Quirónsalud Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Micancer Center S.L.P.
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Policlinica Gipuzkoa S.A.
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DonostiaSpainRecruiting
Hospital Universitario De Leon
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LeónSpainRecruiting
Hospital Universitario de la Princesa
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital General De Tomelloso
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TomellosoSpainRecruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Centre Hospitalier Regional D'Angers
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AngersFranceRecruiting
CHU Besançon
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BesançonFranceRecruiting
Assistance Publique Hopitaux De Paris
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BobignyFranceRecruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceRecruiting
Hopital Beaujon
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ClichyFranceRecruiting
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Hopital De La Croix-Rousse
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Lyon Cedex 04FranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Hopitaux Universitaires Pitie Salpetriere
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ParisFranceRecruiting
Hopital Saint Antoine
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Paris Cedex 12FranceRecruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Sante Atlantique
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St HerblainFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceRecruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceRecruiting
Hopital Paul Brousse
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Villejuif CedexFranceRecruiting
Hippokration Hospital
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AthensGreeceRecruiting
Evangelismos S A
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AthensGreeceRecruiting
Laiko General Hospital of Athens
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AthensGreeceRecruiting
University General Hospital of Heraklion
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HeraklionGreeceRecruiting
Hippokration Hospital
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ThessalonikiGreeceRecruiting
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceRecruiting
GSK Investigational Site
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PokfulamHong Kong SAR ChinaRecruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyRecruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Azienda Ospedaliera di Padova
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PadovaItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
GSK Investigational Site
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GunmaJapanRecruiting
GSK Investigational Site
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KagoshimaJapanRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsNot yet recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsNot yet recruiting
Bernhoven B.V.
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UdenNetherlandsNot yet recruiting
GSK Investigational Site
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WellingtonNew ZealandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandRecruiting
Gyncentrum Sp. z o.o.
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KatowicePolandRecruiting
Pratia S.A.
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KatowicePolandRecruiting
Amicare Sp. z o.o. S.K.
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LodzPolandRecruiting
Santa SP. z o.o
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LodzPolandRecruiting
Medrise Sp. z o.o.
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LublinPolandRecruiting
ID Clinic Arkadiusz Pisula
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MyslowicePolandRecruiting
Solumed Centrum Medyczne Sp. z o.o.
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PoznanPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Melita Medical Sp. z o.o.
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WroclawPolandRecruiting
GSK Investigational Site
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RiyadhSaudi ArabiaRecruiting
GSK Investigational Site
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AkronUnited StatesRecruiting
GSK Investigational Site
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ArcadiaUnited StatesRecruiting
GSK Investigational Site
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AustinUnited StatesRecruiting
GSK Investigational Site
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Boynton BeachUnited StatesRecruiting
GSK Investigational Site
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BrownsvilleUnited StatesRecruiting
GSK Investigational Site
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Cape CoralUnited StatesRecruiting
GSK Investigational Site
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ChattanoogaUnited StatesRecruiting
GSK Investigational Site
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ClermontUnited StatesRecruiting
GSK Investigational Site
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CovinaUnited StatesRecruiting
GSK Investigational Site
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DallasUnited StatesRecruiting
GSK Investigational Site
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DeSotoUnited StatesRecruiting
GSK Investigational Site
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DoralUnited StatesRecruiting
GSK Investigational Site
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East SyracuseUnited StatesRecruiting
GSK Investigational Site
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Fort MyersUnited StatesRecruiting
GSK Investigational Site
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HialeahUnited StatesRecruiting
GSK Investigational Site
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HomesteadUnited StatesRecruiting
GSK Investigational Site
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InvernessUnited StatesRecruiting
GSK Investigational Site
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JacksonvilleUnited StatesRecruiting
GSK Investigational Site
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Jersey CityUnited StatesRecruiting
GSK Investigational Site
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KissimmeeUnited StatesRecruiting
GSK Investigational Site
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LakelandUnited StatesRecruiting
GSK Investigational Site
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Los AngelesUnited StatesRecruiting
GSK Investigational Site
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MaitlandUnited StatesRecruiting
GSK Investigational Site
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ManassasUnited StatesRecruiting
GSK Investigational Site
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MarreroUnited StatesRecruiting
GSK Investigational Site
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MiamiUnited StatesRecruiting
GSK Investigational Site
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Miami LakesUnited StatesRecruiting
GSK Investigational Site
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Morehead CityUnited StatesRecruiting
GSK Investigational Site
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New YorkUnited StatesRecruiting
GSK Investigational Site
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OcalaUnited StatesRecruiting
GSK Investigational Site
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Palmetto BayUnited StatesRecruiting
GSK Investigational Site
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RichmondUnited StatesRecruiting
GSK Investigational Site
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San AntonioUnited StatesRecruiting
GSK Investigational Site
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San DiegoUnited StatesRecruiting
GSK Investigational Site
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Santa MariaUnited StatesRecruiting
GSK Investigational Site
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SarasotaUnited StatesRecruiting
GSK Investigational Site
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SeabrookUnited StatesRecruiting
GSK Investigational Site
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SeattleUnited StatesRecruiting
GSK Investigational Site
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SpringboroUnited StatesRecruiting
GSK Investigational Site
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SpringfieldUnited StatesRecruiting
GSK Investigational Site
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St LouisUnited StatesRecruiting
GSK Investigational Site
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Sugar LandUnited StatesRecruiting
GSK Investigational Site
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TomballUnited StatesRecruiting
GSK Investigational Site
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TopekaUnited StatesRecruiting
GSK Investigational Site
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Van NuysUnited StatesRecruiting
GSK Investigational Site
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WacoUnited StatesRecruiting
GSK Investigational Site
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West JordanUnited StatesRecruiting

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