Can a Weight-Loss drug boost Crohn's treatment? new trial aims to find out
NCT ID NCT06937099
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 6 times
Summary
This study tests whether adding the weight-loss drug tirzepatide to the Crohn's drug mirikizumab helps people with moderate-to-severe Crohn's disease who are also overweight or have obesity. About 290 adults will receive either mirikizumab alone or mirikizumab plus tirzepatide. The main goal is to see if more people achieve both gut healing and at least 10% weight loss with the combination.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mirikizumab and tirzepatide
- What this could lead to
- If successful, this could show that adding a weight-loss drug to a Crohn's treatment helps control both gut inflammation and weight, improving overall health.
- What could go wrong
- This is a mid-stage trial with 290 people, so results may not apply to everyone. Adding tirzepatide could cause side effects like nausea or vomiting, and it's unclear if the combination is better than mirikizumab alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis. * 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 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 history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening. * Have had more than 5% body weight change in the past 3 months * Have a current or recent acute, active infection.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Crohn's disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
183 sites in 22 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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(G.I.R.I.) GI Research Institute Foundation
RECRUITINGVancouver, V5Z 2K5, Canada
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AZ Groeninge Campus Kennedylaan
RECRUITINGKortrijk, 8500, Belgium
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AZORG Campus Aalst-Moorselbaan
RECRUITINGAalst, 9300, Belgium
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Aalborg Universitetshospital, Syd
RECRUITINGGistrup, 9260, Denmark
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Aarhus Universitetshospital, Skejby
RECRUITINGAarhus, 8200, Denmark
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Amsterdam UMC, locatie VUmc
RECRUITINGAmsterdam, 1081 HZ, Netherlands
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Antalya Egitim ve Arastırma Hastanesi
RECRUITINGMuratpaşa, 07050, Turkey (Türkiye)
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Assuta Ashdod Medical Center
RECRUITINGAshdod, 7747629, Israel
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Azienda Ospedale - Università Padova
RECRUITINGPadova, 35128, Italy
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Azienda Ospedaliero Universitaria Pisana
RECRUITINGPisa, 56124, Italy
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Bezmialem Vakf Üniversitesi
RECRUITINGIstanbul, 34093, Turkey (Türkiye)
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Boca Clinical Trials Mexico S.C.
RECRUITINGGuadajalara, 44600, Mexico
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Boca Clinical Trials Mexico SC
RECRUITINGPuebla City, 72160, Mexico
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CEDOES
RECRUITINGVitória, 29055450, Brazil
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CEPIC - Centro Paulista de Investigação Clínica
RECRUITINGSão Paulo, 04266-010, Brazil
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CHD Vendee
RECRUITINGLa Roche-sur-Yon, 85000, France
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CHU Charles Nicolle
RECRUITINGRouen, 76031, France
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CHU Rangueil
RECRUITINGToulouse, 31059, France
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CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
RECRUITINGSalvador, 41500-300, Brazil
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CLINFAN Szolgáltató Kft
RECRUITINGSzekszárd, 7100, Hungary
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CMRC Headlands, LLC
RECRUITINGSan Juan, 00918, Puerto Rico
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CPQuali Pesquisa Clínica
RECRUITINGSão Paulo, 01228-000, Brazil
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California Medical Research Associates
RECRUITINGNorthridge, California, 91324, United States
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Capital Digestive Care - Chevy Chase
RECRUITINGChevy Chase, Maryland, 20815, United States
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Care Access - New Iberia
RECRUITINGNew Iberia, Louisiana, 70560, United States
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Care Access - Yonkers
RECRUITINGYonkers, New York, 10701, United States
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Cedars-Sinai Medical Center
RECRUITINGBeverly Hills, California, 90211, United States
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Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
RECRUITINGLiège, 4000, Belgium
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Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
RECRUITINGNice, 06202, France
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Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
RECRUITINGSaint-Priest-en-Jarez, 42270, France
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Centres Médico Chirurgicaux - Clinique Ambroise Paré
RECRUITINGNeuilly-sur-Seine, 92200, France
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Centro Digestivo de Curitiba
RECRUITINGCuritiba, 80430-180, Brazil
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Centro Médico Teknon
RECRUITINGBarcelona, 08022, Spain
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Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
RECRUITINGCiudad Madero, 89440, Mexico
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Centro de Investigacion Clinica Chapultepec
RECRUITINGMorelia, 58260, Mexico
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Centro de Investigación Clinica Chapultepec
RECRUITINGMexico City, 04100, Mexico
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Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
RECRUITINGGuadalajara, 44340, Mexico
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Chu Saint Eloi
RECRUITINGMontpellier, 34295, France
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Clinical Chc Montlégia
RECRUITINGLiège, 4000, Belgium
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Clinical Research Institute S.C.
RECRUITINGTlalnepantla, 54055, Mexico
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Cliniq s.r.o.
RECRUITINGBratislava, 81109, Slovakia
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Clinique IMD
RECRUITINGMontreal, H3H 1E8, Canada
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Clinique des Cèdres
RECRUITINGÉchirolles, 38130, France
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Clínica Hepatogastro JK
RECRUITINGSão Paulo, 04543-011, Brazil
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Coastal Research Institute - Fayetteville
RECRUITINGFayetteville, North Carolina, 28304, United States
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Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide
RECRUITINGFerrol, 15405, Spain
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Complejo Hospitalario de Navarra
RECRUITINGPamplona, 31009, Spain
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Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
RECRUITINGConstanța, 900591, Romania
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Dartmouth-Hitchcock Medical Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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Digestive Health Specialists
RECRUITINGDothan, Alabama, 36301, United States
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Digestive and Liver Center of Florida
RECRUITINGOrlando, Florida, 32825, United States
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ENDOMED
RECRUITINGKošice, 040 13, Slovakia
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ETG Zamość
RECRUITINGZamość, 22-400, Poland
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Edith Wolfson Medical Center
RECRUITINGHolon, 5810001, Israel
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Ege Universitesi Hastanesi
RECRUITINGIzmir, 35100, Turkey (Türkiye)
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EndoArt
RECRUITINGOstrava, 710 00, Czechia
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Erasmus Medisch Centrum
NOT_YET_RECRUITINGRotterdam, 3015 GD, Netherlands
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Eskisehir Osmangazi University
RECRUITINGEskişehir, 26480, Turkey (Türkiye)
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Eugastro GmbH
RECRUITINGLeipzig, 04103, Germany
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Evangelismos General Hospital of Athens
RECRUITINGAthens, 106 76, Greece
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FAICIC S. de R.L. de C.V.
NOT_YET_RECRUITINGVeracruz, 91900, Mexico
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Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
RECRUITINGBanská Bystrica, 97517, Slovakia
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITINGMilan, 20122, Italy
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Fondazione Policlinico Universitario Agostino Gemelli
RECRUITINGRoma, 00168, Italy
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Fundação Universidade de Caxias do Sul (FUCS)
RECRUITINGCaxias do Sul, 95070-560, Brazil
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Galileo Medical Research
RECRUITINGJuiz de Fora, 36033-318, Brazil
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Gastro Health Research - Miami
RECRUITINGMiami, Florida, 33176, United States
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Gastro Health Research - Pensacola
RECRUITINGPensacola, Florida, 32504, United States
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Gastro Intestinal Research Institute of Northern Ohio, LLC
RECRUITINGWestlake, Ohio, 44145, United States
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Gastro LM
RECRUITINGPrešov, 080 01, Slovakia
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Gastroenterologie
RECRUITINGHradec Králové, 500 02, Czechia
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Gastroenterology Associates - Patewood
RECRUITINGGreenville, South Carolina, 29607, United States
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Gastroenterology Center Of The Midsouth
RECRUITINGCordova, Tennessee, 38018, United States
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Gastroenterology Health Partners
RECRUITINGNew Albany, Indiana, 47150, United States
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Gastroenterology Health Partners
RECRUITINGLouisville, Kentucky, 40218, United States
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Gastroenterology Research of San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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Gastroenterology and internal medicine research institute
NOT_YET_RECRUITINGEdmonton, T5R 1W2, Canada
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Gazi University Health Research and Application Center Gazi Hospital
RECRUITINGAnkara, 06560, Turkey (Türkiye)
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Grand Teton Research Group
RECRUITINGIdaho Falls, Idaho, 83404, United States
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Health Pharma Querétaro
NOT_YET_RECRUITINGJuriquilla, 76230, Mexico
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Herlev and Gentofte Hospital
RECRUITINGCopenhagen, 2730, Denmark
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Hospital General Universitario Gregorio Marañon
RECRUITINGMadrid, 28028, Spain
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Hospital General de Occidente
NOT_YET_RECRUITINGGuadalajara, 45170, Mexico
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Hospital Universitari Vall d'Hebron
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitari i Politecnic La Fe
RECRUITINGValencia, 46026, Spain
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Hospital Universitario Central de Asturias
RECRUITINGOviedo, 33011, Spain
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Hospital Universitario La Paz
RECRUITINGMadrid, 28046, Spain
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Hospital Universitario Virgen Macarena
RECRUITINGSeville, 41009, Spain
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Hospital de Cabueñes
RECRUITINGGijón, 33394, Spain
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Hospital de Clinicas de Porto Alegre
RECRUITINGPorto Alegre, 90035-903, Brazil
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Hospital de Clínicas de Ribeirão Preto
RECRUITINGRibeirão Preto, 14051-140, Brazil
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Humanitas
RECRUITINGRozzano, 20089, Italy
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Hôpital Saint Antoine
RECRUITINGParis, 75571, France
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Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
RECRUITINGLe Kremlin-Bicêtre, 94270, France
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IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
RECRUITINGBologna, 40138, Italy
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IRMED
RECRUITINGPiotrkow Trybunalski, 97-300, Poland
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ISCARE klinické centrum
RECRUITINGPrague, 19000, Czechia
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Ikazia Ziekenhuis
RECRUITINGRotterdam, 3083 AN, Netherlands
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Indiana University Health University Hospital
RECRUITINGIndianapolis, Indiana, 46202, United States
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
NOT_YET_RECRUITINGMexico City, 14080, Mexico
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Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
NOT_YET_RECRUITINGDurango, 34000, Mexico
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Integral Pesquisa e Ensino
RECRUITINGVotuporanga, 15500-269, Brazil
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Ippokrateio General Hospital of Thessaloniki
RECRUITINGThessaloniki, 54642, Greece
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Klinikum Ernst von Bergmann
RECRUITINGPotsdam, 14467, Germany
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Kocaeli University Medical Faculty Hospital
RECRUITINGİzmit, 41380, Turkey (Türkiye)
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Korczowski Bartosz, Gabinet Lekarski
RECRUITINGRzeszów, 35-302, Poland
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L2IP - Instituto de Pesquisas Clínicas
RECRUITINGBrasília, 70200730, Brazil
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Loema Instituto de Pesquisa Clinica
RECRUITINGCampinas, 13092-133, Brazil
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London Digestive Disease Institute
RECRUITINGLondon, N6K 1M6, Canada
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London Health Sciences Centre
RECRUITINGLondon, N6A 5W9, Canada
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Louisiana Research Center
RECRUITINGShreveport, Louisiana, 71105, United States
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Lucida Clinical Trials
RECRUITINGNew Bedford, Massachusetts, 02740, United States
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Masarykova Nemocnice V Usti Nad Labem
RECRUITINGÚstí nad Labem, 40113, Czechia
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Medical Care and Research SA de CV
RECRUITINGMérida, 97070, Mexico
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Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
RECRUITINGWarsaw, 04-501, Poland
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Medizinische Hochschule Hannover
RECRUITINGHanover, 30625, Germany
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Medizinische Universitaet Innsbruck
RECRUITINGInnsbruck, 6020, Austria
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Medizinische Universität Graz
RECRUITINGGraz, 8036, Austria
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Medizinische Universität Wien
RECRUITINGVienna, 1090, Austria
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Medrise Sp. z o.o.
RECRUITINGLublin, 20-582, Poland
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Melita Medical
RECRUITINGWroclaw, 53-611, Poland
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Mersin University
RECRUITINGMersin, 33110, Turkey (Türkiye)
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Mustafa Kemal Universitesi
RECRUITINGHatay, 31030, Turkey (Türkiye)
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NZOZ GynCentrum - Oddział Warszawa
RECRUITINGWarsaw, 00-124, Poland
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New York Gastroenterology Associates
RECRUITINGNew York, New York, 10075, United States
-
NewData Clinical Research - Aracaju
RECRUITINGAracaju, 49075-000, Brazil
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Odense Universitetshospital
RECRUITINGOdense, 5000, Denmark
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Orlando Health
RECRUITINGOrlando, Florida, 32806, United States
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Ospedale Di Circolo
RECRUITINGRho, 20017, Italy
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Ospedale San Raffaele
NOT_YET_RECRUITINGMilan, 20132, Italy
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Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
RECRUITINGCastellana Grotte, 70013, Italy
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Pesquisare Saude
RECRUITINGSanto André, 09080-110, Brazil
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Praxiszentrum für Gastroenterologie
RECRUITINGGrevenbroich, 41515, Germany
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Precision Clinical Research
RECRUITINGSunrise, Florida, 33351, United States
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Rabin Medical Center
RECRUITINGPetah Tikva, 4941492, Israel
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Radboudumc
NOT_YET_RECRUITINGNijmegen, 6525 GA, Netherlands
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Rambam Health Care Campus
RECRUITINGHaifa, 3109601, Israel
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ResTrial GastroEndo s.r.o
RECRUITINGPrague, 143 00, Czechia
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Research Associates of South Florida - Miami - Southwest 8th Street
RECRUITINGMiami, Florida, 33134, United States
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Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
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Rush University Medical Center
RECRUITINGChicago, Illinois, 60612, United States
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S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
RECRUITINGTimișoara, 300002, Romania
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San Peregrino Unidad de Investigación
NOT_YET_RECRUITINGAguascalientes, 20230, Mexico
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Scientia Investigacion Clinica S.C.
RECRUITINGChihuahua City, 31207, Mexico
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Semmelweis Egyetem
RECRUITINGBudapest, 1082, Hungary
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Semmelweis Egyetem
RECRUITINGBudapest, 1088, Hungary
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Servicios de Oncología Médica Integral - Monterrey
RECRUITINGMonterrey, 66220, Mexico
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Shaare Zedek Medical Center
RECRUITINGJerusalem, 9103102, Israel
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Sheba Medical Center
RECRUITINGRamat Gan, 5262100, Israel
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Smart Cures Clinical Research
RECRUITINGAnaheim, California, 92806, United States
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Sourasky Medical Center
RECRUITINGTel Aviv, 6423906, Israel
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Southern Star Research Institute
RECRUITINGSan Antonio, Texas, 78229, United States
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Spitalul Clinic Colentina
RECRUITINGBucharest, 020125, Romania
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Spitalul Clinic Județean de Urgență
RECRUITINGCraiova, 200642, Romania
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Spitalul Județean de Urgență Bacău
RECRUITINGBacau, 600114, Romania
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Spitalul Universitar de Urgență București
RECRUITINGBucharest, 050098, Romania
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Studiengesellschaft Mitteldeutschland GmbH
RECRUITINGHalle, 06108, Germany
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SurGal Clinic
RECRUITINGBrno, 602 00, Czechia
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Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
RECRUITINGSzeged, 6725, Hungary
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The Ottawa Hospital - General Campus
NOT_YET_RECRUITINGOttawa, K1H 8L6, Canada
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Thomas Jefferson University - Medicine/GI and Hepatology
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Thoracic General Hospital of Athens "I Sotiria"
RECRUITINGAthens, 115 27, Greece
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Twoja Przychodnia Opolskie Centrum Medyczne
RECRUITINGOpole, 45-819, Poland
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Twoja Przychodnia PCM
RECRUITINGPoznan, 60-324, Poland
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Twoja Przychodnia SCM
RECRUITINGSzczecin, 71-434, Poland
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Tyler Research Institute
RECRUITINGTyler, Texas, 75701, United States
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UZ Leuven
RECRUITINGLeuven, 3000, Belgium
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Uludag Universitesi
RECRUITINGBursa, 16059, Turkey (Türkiye)
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United Medical Doctors - Los Alamitos
RECRUITINGLos Alamitos, California, 90720, United States
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Universitair Medisch Centrum Utrecht
RECRUITINGUtrecht, 3584 CX, Netherlands
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University Gastroenterology
RECRUITINGProvidence, Rhode Island, 02905, United States
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University General Hospital of Heraklion
RECRUITINGHeraklion, 711 10, Greece
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University Hospital "St. Ivan Rilski"
RECRUITINGGorna Oryahovitsa, 5100, Bulgaria
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Universitätsklinikum Frankfurt Goethe-Universität
RECRUITINGFrankfurt, 60590, Germany
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Université Libre de Bruxelles - Hôpital Erasme
RECRUITINGBrussels, 1070, Belgium
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Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
RECRUITINGPoznan, 60-354, Poland
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Vancouver General Hospital
NOT_YET_RECRUITINGVancouver, V5Z 1M9, Canada
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Vejle Sygehus
RECRUITINGVejle, 7100, Denmark
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Vivamed Sp. z o.o.
RECRUITINGWarsaw, 03-580, Poland
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Washington Gastroenterology - Tacoma
RECRUITINGTacoma, Washington, 98405, United States
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
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Wisconsin Center for Advanced Research
RECRUITINGMilwaukee, Wisconsin, 53215, United States
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Yitzhak Shamir Medical Center
RECRUITINGẔerifin, 7033001, Israel
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