Phase
Condition
Obesity
Ulcerative Colitis
Diabetes Prevention
Treatment
Placebo
Mirikizumab
Tirzepatide
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have had a diagnosis of Crohn's disease (CD) or perianal fistulizing CD establishedat least 3 months prior to enrollment confirmed by clinical, endoscopic, andhistological criteria.
Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m2), oroverweight (BMI ≥27 kg/m2 to <30 kg/m2) and in the presence of at least 1 of theseweight-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 atbaseline.
Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6for patients with ileal-colonic or ≥4 for patients with isolated ileal diseasewithin 21 days before the first dose of study treatment.
Have a history of CD involving only or predominantly the colon for greater than orequal to 8 years with a surveillance colonoscopy within 1 year prior to baselinemust have documented negative results for colorectal dysplasia and cancer.
Have an inadequate response to, loss of response to, or intolerance to:
at least one conventional therapy (such as corticosteroids, oral azathioprine (AZA) or 60-mercaptopurine (6-MP), or oral aminosalicylates (for example,mesalamine, sulfasalazine, olsalazine, balsalazide) and/or,
at least one advanced therapy for CD (defined as: a biologic or biosimilarmedication such as anti-tumor necrosis factor (TNF) antibodies, anti-integrinantibodies, Janus kinase (JAK) inhibitors such as upadacitinib, oranti-interleukin (IL)-12p40 antibodies, for example, ustekinumab).
Exclusion
Exclusion Criteria:
Have a current diagnosis of Ulcerative Colitis (UC), inflammatory boweldisease-unclassified (formerly known as indeterminate colitis), or primarysclerosing 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, diagnosis of short bowelsyndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3months 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 6months prior to screening.
Have had more than 5% body weight change in the past 3 months
Have a current or recent acute, active infection.
Study Design
Connect with a study center
Medizinische Universität Graz
Graz, Steiermark 8036
AustriaSite Not Available
Medizinische Universitaet Innsbruck
Innsbruck, Tirol 6020
AustriaSite Not Available
Medizinische Universität Wien
Vienna, Wien 1090
AustriaSite Not Available
Clinical Chc Montlégia
Liege, Liège 4000
BelgiumSite Not Available
AZORG Campus Aalst-Moorselbaan
Aalst, Oost-Vlaanderen 9300
BelgiumSite Not Available
UZ Leuven
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
AZ Groeninge Campus Kennedylaan
Kortrijk, West-Vlaanderen 8500
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
BelgiumSite Not Available
CEDOES
Vitória, Espírito Santo 29055450
BrazilSite Not Available
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do sul, Rio Grande Do Sul 95070-560
BrazilSite Not Available
NewData Clinical Research - Aracaju
Aracaju, Sergipe 49075-000
BrazilSite Not Available
Loema Instituto de Pesquisa Clinica
Campinas, São Paulo 13092-133
BrazilSite Not Available
CPQuali Pesquisa Clínica
São Paulo, 01228-000
BrazilSite Not Available
Clínica Hepatogastro JK
São Paulo, 04543-011
BrazilSite Not Available
(G.I.R.I.) GI Research Institute Foundation
Vancouver, British Columbia V5Z 2K5
CanadaSite Not Available
SurGal Clinic
Brno, Brno-město 602 00
CzechiaSite Not Available
Nemocnice České Budějovice
České Budějovice, Jihočeský Kraj 370 01
CzechiaSite Not Available
Krajská nemocnice Liberec
Turnov, Liberecký Kraj 51101
CzechiaSite Not Available
EndoArt
Ostrava, Moravskoslezský Kraj 710 00
CzechiaSite Not Available
ResTrial GastroEndo s.r.o
Prague, Praha 4 143 00
CzechiaSite Not Available
ISCARE klinické centrum
Prague, Praha 9 19000
CzechiaSite Not Available
Masarykova Nemocnice V Usti Nad Labem
Usti nad Labem, Ústí Nad Labem 40113
CzechiaSite Not Available
Gastroenterologie
Hradec Králové, 500 02
CzechiaSite Not Available
Herlev and Gentofte Hospital
Copenhagen, Hovedstaden 2730
DenmarkSite Not Available
Rigshospitalet
Copenhagen, Hovedstaden 2100
DenmarkSite Not Available
Aarhus Universitetshospital, Skejby
Aarhus, Midtjylland 8200
DenmarkSite Not Available
Aalborg Universitetshospital, Syd
Aalborg, Nordjylland 9000
DenmarkSite Not Available
Vejle Sygehus
Vejle, Syddanmark 7100
DenmarkSite Not Available
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, Alpes-Maritimes 06202
FranceSite Not Available
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, Bouches-du-Rhône 13915
FranceSite Not Available
Clinique Pasteur
Toulouse, Haute-Garonne 31076
FranceSite Not Available
CHU Charles Nicolle
Rouen, Haute-Normandie 76031
FranceSite Not Available
Clinique des Cèdres
Échirolles, Isère 38130
FranceSite Not Available
Chu Saint Eloi
Montpellier, Languedoc-Roussillon 34295
FranceSite Not Available
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, Paris 94270
FranceSite Not Available
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil, Paris 93370
FranceSite Not Available
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez, Rhône-Alpes 42270
FranceSite Not Available
CHD Vendee
La Roche-sur-Yon, Vendée 85000
FranceSite Not Available
Klinikum Ernst von Bergmann
Potsdam, Brandenburg 14467
GermanySite Not Available
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, Hessen 60590
GermanySite Not Available
Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
Frankfurt am Main, Hessen 60313
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, Niedersachsen 30625
GermanySite Not Available
Praxiszentrum für Gastroenterologie
Grevenbroich, Nordrhein-Westfalen 41515
GermanySite Not Available
Eugastro GmbH
Leipzig, Sachsen 04103
GermanySite Not Available
Studiengesellschaft BSF Unternehmergesellschaft
Halle (Saale), Sachsen-Anhalt 06108
GermanySite Not Available
Evangelismos General Hospital of Athens
Athens, Attikí 106 76
GreeceSite Not Available
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí 115 27
GreeceSite Not Available
University Hospital of Ioannina
Ioannina, Ioánnina 455 00
GreeceSite Not Available
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía 54642
GreeceSite Not Available
University General Hospital of Heraklion
Heraklion, Krítí 711 10
GreeceSite Not Available
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád 6725
HungarySite Not Available
CLINFAN Szolgáltató Kft
Szekszárd, Tolna 7100
HungarySite Not Available
Semmelweis Egyetem
Budapest, 1088
HungarySite Not Available
Assuta Ashdod Medical Center
Ashdod, HaDarom 7747629
IsraelSite Not Available
Edith Wolfson Medical Center
Holon, HaMerkaz 5810001
IsraelSite Not Available
Rabin Medical Center
Petah Tikva, HaMerkaz 4941492
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, HaMerkaz 5262100
IsraelSite Not Available
Yitzhak Shamir Medical Center
Zerifin, HaMerkaz 7033001
IsraelSite Not Available
Rambam Health Care Campus
Haifa, HaTsafon 3109601
IsraelSite Not Available
Sourasky Medical Center
Tel Aviv, Tell Abīb 6423906
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, Yerushalayim 9103102
IsraelSite Not Available
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Lazio 00168
ItalySite Not Available
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, Lombardia 20122
ItalySite Not Available
Humanitas
Rozzano, Lombardia 20089
ItalySite Not Available
Ospedale Di Circolo
Rho, Milano 20017
ItalySite Not Available
Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
Castellana Grotte, Puglia 70013
ItalySite Not Available
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
Palermo, Sicilia 90146
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Pisa, Toscana 56124
ItalySite Not Available
Azienda Ospedale - Università Padova
Padova, Veneto 35128
ItalySite Not Available
Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Boca Clinical Trials Mexico S.C.
Guadajalara, Jalisco 44600
MexicoSite Not Available
Servicios de Oncología Médica Integral - Monterrey
Monterrey, Nuevo León 66220
MexicoSite Not Available
Health Pharma Querétaro
Juriquilla, Querétaro 76230
MexicoSite Not Available
Scientia Investigacion Clinica S.C.
Chihuahua, 31207
MexicoSite Not Available
Centro de Investigación Clinica Chapultepec
Mexico City, 04100
MexicoSite Not Available
Amsterdam UMC, locatie VUmc
Amsterdam, Noord-Holland 1081 HZ
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, Zuid-Holland 3015 GD
NetherlandsSite Not Available
Ikazia Ziekenhuis
Rotterdam, Zuid-Holland 3083 AN
NetherlandsSite Not Available
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
NetherlandsSite Not Available
Melita Medical
Wroclaw, Dolnośląskie 53-611
PolandSite Not Available
Medrise Sp. z o.o.
Lublin, Lubelskie 20-582
PolandSite Not Available
ETG Zamość
Zamość, Lubelskie 22-400
PolandSite Not Available
NZOZ GynCentrum - Oddział Warszawa
Warsaw, Mazowieckie 00-124
PolandSite Not Available
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warszawa, Mazowieckie 04-501
PolandSite Not Available
Vivamed Sp. z o.o.
Warszawa, Mazowieckie 03-580
PolandSite Not Available
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie 35-302
PolandSite Not Available
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan, Wielkopolskie 60-354
PolandSite Not Available
Twoja Przychodnia PCM
Poznań, Wielkopolskie 60-324
PolandSite Not Available
Twoja Przychodnia SCM
Szczecin, Zachodniopomorskie 71-434
PolandSite Not Available
IRMED
Piotrkow Trybunalski, Łódzkie 97-300
PolandSite Not Available
Spitalul Județean de Urgență Bacău
Bacau, Bacău 600114
RomaniaSite Not Available
Spitalul Clinic Colentina
Bucuresti, București 020125
RomaniaSite Not Available
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanta, Constanța 900591
RomaniaSite Not Available
Spitalul Clinic Județean de Urgență
Craiova, Dolj 200642
RomaniaSite Not Available
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timisoara, Timiș 300002
RomaniaSite Not Available
Spitalul Universitar de Urgență București
București, 050098
RomaniaSite Not Available
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banska Bystrica, Banskobystrický Kraj 97517
SlovakiaSite Not Available
Cliniq s.r.o.
Bratislava, Bratislavský Kraj 81109
SlovakiaSite Not Available
ENDOMED
Kosice, Košický Kraj 040 13
SlovakiaSite Not Available
Gastro LM
Presov, 080 01
SlovakiaSite Not Available
Hospital de Cabueñes
Gijón, Asturias 33394
SpainSite Not Available
Hospital Universitario Central de Asturias
Oviedo, Asturias 33011
SpainSite Not Available
Centro Médico Teknon
Barcelona, Barcelona [Barcelona] 08022
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Hospital Galdakao-Usansolo
Galdakao, Bizkaia 48960
SpainSite Not Available
Complejo Hospitalario de Navarra
Pamplona, Navarra 31009
SpainSite Not Available
Hospital General Universitario Gregorio Marañon
Madrid, 28028
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario Virgen Macarena
Sevilla, 41009
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
València, 46026
SpainSite Not Available
Eskisehir Osmangazi University
Eskisehir, Eskişehir 26480
TurkeySite Not Available
Kocaeli University Medical Faculty Hospital
Izmit, Kocaeli 41380
TurkeySite Not Available
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100
TurkeySite Not Available
Uludag Universitesi
Bursa, 16059
TurkeySite Not Available
Mustafa Kemal Universitesi
Hatay, 31030
TurkeySite Not Available
Bezmialem Vakf Üniversitesi
Istanbul, 34093
TurkeySite Not Available
Mersin University
Mersin, 33343
TurkeySite Not Available
Ege Universitesi Hastanesi
İzmir, 35100
TurkeySite Not Available
California Medical Research Associates
Northridge, California 91324
United StatesSite Not Available
Precision Clinical Research
Sunrise, Florida 33351
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Indiana University Health University Hospital
Indianapolis, Indiana 46202
United StatesSite Not Available
Lucida Clinical Trials
New Bedford, Massachusetts 02740
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
University Gastroenterology - Providence - West River Street
Providence, Rhode Island 02904
United StatesSite Not Available
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