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NCT06937099RecruitingPhase 3

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
290 (estimated)
First submitted
18 Apr 2025
Start date
26 Jun 2025
Primary completion date
May 2028
Lead sponsor
Eli Lilly and Company
NCT number
NCT06937099
EU CT number
2024-520210-21-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 290
  • From 26 Jun 2025 to the primary completion date, May 2028
  • 182 sites in 22 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

  • Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.

Other illness

  • Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
  • Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
  • Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
  • Have a current or recent acute, active infection.

Other

  • Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.
  • Currently have or are suspected to have an abscess.
  • Have a stoma, ileoanal pouch, or ostomy.
  • Have had more than 5% body weight change in the past 3 months

Who the study is looking for

  • Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
  • Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to \<30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:
    • hypertension
    • Type 2 diabetes mellitus (T2DM)
    • dyslipidemia
    • obstructive sleep apnea, or
    • cardiovascular disease.
  • Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
  • Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.
  • Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.
  • Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (182)

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

SiteCityCountrySite status
Medizinische Universität Graz
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GrazAustriaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Medizinische Universität Wien
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ViennaAustriaRecruiting
AZORG Campus Aalst-Moorselbaan
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AalstBelgiumRecruiting
Université Libre de Bruxelles - Hôpital Erasme
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BrusselsBelgiumRecruiting
AZ Groeninge Campus Kennedylaan
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KortrijkBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
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LiègeBelgiumRecruiting
Clinical Chc Montlégia
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LiègeBelgiumRecruiting
University Hospital "St. Ivan Rilski"
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Gorna OryahovitsaBulgariaRecruiting
NewData Clinical Research - Aracaju
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AracajuBrazilRecruiting
L2IP - Instituto de Pesquisas Clínicas
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BrasíliaBrazilRecruiting
Loema Instituto de Pesquisa Clinica
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CampinasBrazilRecruiting
Fundação Universidade de Caxias do Sul (FUCS)
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Caxias do SulBrazilRecruiting
Centro Digestivo de Curitiba
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CuritibaBrazilRecruiting
Galileo Medical Research
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Juiz de ForaBrazilRecruiting
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilRecruiting
Hospital de Clínicas de Ribeirão Preto
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Ribeirão PretoBrazilRecruiting
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
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SalvadorBrazilRecruiting
Pesquisare Saude
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Santo AndréBrazilRecruiting
Clínica Hepatogastro JK
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São PauloBrazilRecruiting
CPQuali Pesquisa Clínica
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São PauloBrazilRecruiting
CEPIC - Centro Paulista de Investigação Clínica
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São PauloBrazilRecruiting
CEDOES
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VitóriaBrazilRecruiting
Integral Pesquisa e Ensino
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VotuporangaBrazilRecruiting
Gastroenterology and internal medicine research institute
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EdmontonCanadaRecruiting
London Health Sciences Centre
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LondonCanadaRecruiting
London Digestive Disease Institute
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LondonCanadaRecruiting
Clinique IMD
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MontrealCanadaRecruiting
The Ottawa Hospital - General Campus
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OttawaCanadaNot yet recruiting
Vancouver General Hospital
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VancouverCanadaRecruiting
(G.I.R.I.) GI Research Institute Foundation
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VancouverCanadaRecruiting
SurGal Clinic
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BrnoCzechiaRecruiting
Gastroenterologie
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Hradec KrálovéCzechiaRecruiting
EndoArt
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OstravaCzechiaRecruiting
ISCARE klinické centrum
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PragueCzechiaRecruiting
ResTrial GastroEndo s.r.o
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PragueCzechiaRecruiting
Masarykova nemocnice v Usti nad Labem
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Ústí nad LabemCzechiaRecruiting
Universitätsklinikum Frankfurt Goethe-Universität
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FrankfurtGermanyRecruiting
Praxiszentrum für Gastroenterologie
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GrevenbroichGermanyRecruiting
Studiengesellschaft Mitteldeutschland GmbH
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HalleGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Eugastro GmbH
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LeipzigGermanyRecruiting
Klinikum Ernst von Bergmann
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PotsdamGermanyRecruiting
Aarhus Universitetshospital, Skejby
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AarhusDenmarkRecruiting
Rigshospitalet
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CopenhagenDenmarkRecruiting
Herlev and Gentofte Hospital
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CopenhagenDenmarkRecruiting
Aalborg Universitetshospital, Syd
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GistrupDenmarkRecruiting
Odense Universitetshospital
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OdenseDenmarkRecruiting
Vejle Sygehus
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VejleDenmarkRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Centro Médico Teknon
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BarcelonaSpainRecruiting
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide
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FerrolSpainRecruiting
Hospital de Cabuenes
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GijónSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
Complejo Hospitalario de Navarra
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PamplonaSpainRecruiting
Hospital Universitario Virgen Macarena
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SevilleSpainRecruiting
Hospital Universitari i Politécnic La Fe
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ValenciaSpainRecruiting
Clinique des Cèdres
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ÉchirollesFranceRecruiting
CHD Vendée
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La Roche-sur-YonFranceRecruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
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Le Kremlin-BicêtreFranceRecruiting
CHU Saint-Eloi
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MontpellierFranceRecruiting
Centres Médico Chirurgicaux - Clinique Ambroise Paré
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Neuilly-sur-SeineFranceRecruiting
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
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NiceFranceRecruiting
Hôpital Saint-Antoine
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ParisFranceRecruiting
CHU Charles Nicolle
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RouenFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord
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Saint-Priest-en-JarezFranceRecruiting
CHU Rangueil
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ToulouseFranceRecruiting
Evangelismos General Hospital of Athens
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AthensGreeceRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
University General Hospital of Heraklion
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HeraklionGreeceRecruiting
Ippokrateio General Hospital of Thessaloniki
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ThessalonikiGreeceRecruiting
Semmelweis Egyetem
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BudapestHungaryRecruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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SzegedHungaryRecruiting
CLINFAN Szolgáltató Kft
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SzekszárdHungaryRecruiting
Assuta Ashdod Medical Center
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AshdodIsraelRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Edith Wolfson Medical Center
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HolonIsraelRecruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Sourasky Medical Center
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Tel AvivIsraelRecruiting
Yitzhak Shamir Medical Center
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TsrifinIsraelRecruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
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BolognaItalyRecruiting
Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
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Castellana GrotteItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Ospedale San Raffaele
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MilanItalyRecruiting
Azienda Ospedale Universita Padova
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PadovaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Ospedale Di Circolo
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RhoItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli
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RomaItalyRecruiting
Humanitas
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RozzanoItalyRecruiting
San Peregrino Unidad de Investigacion
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AguascalientesMexicoNot yet recruiting
Scientia Investigacion Clinica S.C.
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Chihuahua CityMexicoRecruiting
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
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Ciudad MaderoMexicoRecruiting
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
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DurangoMexicoNot yet recruiting
Boca Clinical Trials Mexico S.C.
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GuadajalaraMexicoRecruiting
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
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GuadalajaraMexicoRecruiting
Hospital General de Occidente
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GuadalajaraMexicoNot yet recruiting
Health Pharma Querétaro
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JuriquillaMexicoNot yet recruiting
Medical Care and Research Sa de Cv
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MéridaMexicoRecruiting
Centro de Investigacion Clinica Chapultepec
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Mexico CityMexicoRecruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
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Mexico CityMexicoNot yet recruiting
Servicios de Oncología Médica Integral - Monterrey
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MonterreyMexicoRecruiting
Centro de Investigacion Clinica Chapultepec
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MoreliaMexicoRecruiting
Boca Clinical Trials Mexico Sc.
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Puebla CityMexicoRecruiting
Clinical Research Institute S.C.
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TlalnepantlaMexicoRecruiting
FAICIC S. de R.L. de C.V.
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VeracruzMexicoNot yet recruiting
Amsterdam UMC Locatie VUMC
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AmsterdamNetherlandsRecruiting
Radboudumc
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NijmegenNetherlandsNot yet recruiting
Erasmus Medisch Centrum
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RotterdamNetherlandsNot yet recruiting
Ikazia Ziekenhuis
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RotterdamNetherlandsRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Medrise Sp. z o.o.
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LublinPolandRecruiting
Twoja Przychodnia Opolskie Centrum Medyczne
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OpolePolandRecruiting
IRMED
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Piotrkow TrybunalskiPolandRecruiting
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
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PoznanPolandRecruiting
Twoja Przychodnia PCM
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PoznanPolandRecruiting
Korczowski Bartosz, Gabinet Lekarski
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RzeszówPolandRecruiting
Twoja Przychodnia SCM
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SzczecinPolandRecruiting
Vivamed Sp. z o.o.
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WarsawPolandRecruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
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WarsawPolandRecruiting
NZOZ GynCentrum - Oddział Warszawa
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WarsawPolandRecruiting
Melita Medical
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WroclawPolandRecruiting
ETG Zamosc
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ZamośćPolandRecruiting
CMRC Headlands, LLC
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San JuanPuerto RicoRecruiting
Spitalul Județean de Urgență Bacău
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BacauRomaniaRecruiting
Spitalul Universitar de Urgență București
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BucharestRomaniaRecruiting
Spitalul Clinic Colentina
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BucharestRomaniaRecruiting
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
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ConstanțaRomaniaRecruiting
Spitalul Clinic Județean de Urgență
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CraiovaRomaniaRecruiting
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
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TimișoaraRomaniaRecruiting
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
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Banská BystricaSlovakiaRecruiting
Cliniq s.r.o.
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BratislavaSlovakiaRecruiting
ENDOMED
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KošiceSlovakiaRecruiting
Gastro LM
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PrešovSlovakiaRecruiting
Smart Cures Clinical Research
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AnaheimUnited StatesRecruiting
Cedars-Sinai Medical Center
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Beverly HillsUnited StatesRecruiting
Capital Digestive Care - Chevy Chase
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Chevy ChaseUnited StatesRecruiting
Rush University Medical Center
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ChicagoUnited StatesRecruiting
Gastroenterology Center Of The Midsouth
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CordovaUnited StatesRecruiting
Digestive Health Specialists
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DothanUnited StatesRecruiting
Coastal Research Institute - Fayetteville
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FayettevilleUnited StatesRecruiting
Gastroenterology Associates - Patewood
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GreenvilleUnited StatesRecruiting
Grand Teton Research Group
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Idaho FallsUnited StatesRecruiting
Indiana University Health University Hospital
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IndianapolisUnited StatesRecruiting
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesRecruiting
United Medical Doctors - Los Alamitos
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Los AlamitosUnited StatesRecruiting
Gastroenterology Health Partners
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LouisvilleUnited StatesRecruiting
Research Associates of South Florida - Miami - Southwest 8th Street
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MiamiUnited StatesRecruiting
Gastro Health Research - Miami
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MiamiUnited StatesRecruiting
Wisconsin Center for Advanced Research
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MilwaukeeUnited StatesRecruiting
Gastroenterology Health Partners
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New AlbanyUnited StatesRecruiting
Lucida Clinical Trials
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New BedfordUnited StatesRecruiting
Care Access - New Iberia
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New IberiaUnited StatesRecruiting
New York Gastroenterology Associates
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New YorkUnited StatesRecruiting
California Medical Research Associates
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NorthridgeUnited StatesRecruiting
Orlando Health
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OrlandoUnited StatesRecruiting
Digestive and Liver Center of Florida
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OrlandoUnited StatesRecruiting
Gastro Health Research - Pensacola
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PensacolaUnited StatesRecruiting
Thomas Jefferson University - Medicine/GI and Hepatology
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PhiladelphiaUnited StatesRecruiting
University Gastroenterology
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ProvidenceUnited StatesRecruiting
Southern Star Research Institute
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San AntonioUnited StatesRecruiting
Gastroenterology Research of San Antonio
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San AntonioUnited StatesRecruiting
Louisiana Research Center
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ShreveportUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Precision Clinical Research
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SunriseUnited StatesRecruiting
Washington Gastroenterology - Tacoma
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TacomaUnited StatesRecruiting
Tyler Research Institute
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TylerUnited StatesRecruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC
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WestlakeUnited StatesRecruiting
Care Access - Yonkers
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YonkersUnited StatesRecruiting
Gazi University Health Research and Application Center Gazi Hospital
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AnkaraTurkey (Türkiye)Recruiting
Uludag Universitesi
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BursaTurkey (Türkiye)Recruiting
Eskisehir Osmangazi University
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EskişehirTurkey (Türkiye)Recruiting
Mustafa Kemal Universitesi
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HatayTurkey (Türkiye)Recruiting
Bezmialem Vakf Üniversitesi
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IstanbulTurkey (Türkiye)Recruiting
Ege Universitesi Hastanesi
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IzmirTurkey (Türkiye)Recruiting
Kocaeli University Medical Faculty Hospital
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İzmitTurkey (Türkiye)Recruiting
Mersin University
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MersinTurkey (Türkiye)Recruiting
Antalya Egitim ve Arastırma Hastanesi
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MuratpaşaTurkey (Türkiye)Recruiting

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