New combo therapy targets gut disease and obesity together
NCT ID NCT06937086
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 8 times
Summary
This phase 3 trial tests whether adding tirzepatide (a weight-loss drug) to mirikizumab (an anti-inflammatory drug) helps people with moderate-to-severe ulcerative colitis who are also overweight or obese. The goal is to see if the combination can reduce both gut symptoms and body weight. About 350 adults will take part for up to 61 weeks.
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 combination could offer a new option for people with ulcerative colitis who also struggle with obesity, potentially controlling both conditions at once.
- What could go wrong
- This is still an early-phase 3 trial with a small sample size. The combination may not work better than mirikizumab alone, and side effects from adding tirzepatide are unknown.
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
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About 350 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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Apr 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 had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline. * Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer. * Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\] * Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions: * hypertension * Type 2 Diabetes Mellitus (T2DM) * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease. * Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab. Exclusion Criteria: * Have a current diagnosis of: * Crohn's disease * inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or * primary sclerosing cholangitis. * Have had or will need bowel resection or intestinal or intra-abdominal surgery. * Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope. * 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 a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening. * Have a current or recent acute, active infection.
Get updates
Get notified about this study
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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
187 sites in 23 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
RECRUITINGAntalya, 07100, 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 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)
NOT_YET_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
NOT_YET_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.
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 Consultants of Southwest Virginia
RECRUITINGRoanoke, Virginia, 24014, 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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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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Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
RECRUITINGKatowice, 40-600, Poland
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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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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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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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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
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NewData Clinical Research - Aracaju
RECRUITINGAracaju, 49075-000, Brazil
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Ninewells Hospital and Medical School
RECRUITINGDundee, DD1 9SY, United Kingdom
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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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Royal Devon & Exeter Hospital
RECRUITINGExeter, EX2 5DW, United Kingdom
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Royal London Hospital
RECRUITINGLondon, E1 2AJ, United Kingdom
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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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Southmead Hospital
RECRUITINGBristol, BS10 5NB, United Kingdom
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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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