Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
Start Date
6/26/2025
Completion Date
4/1/2028
Summary
The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
Mirikizumab
Mirikizumab
Tirzepatide
Placebo
Conditions
Locations
Digestive Health Specialists
Dothan, Alabama 36301
United States
Smart Cures Clinical Research
Anaheim, California 92806
United States
Cedars-Sinai Medical Center
Beverly Hills, California 90211
United States
United Medical Doctors - Los Alamitos
Los Alamitos, California 90720
United States
California Medical Research Associates
Northridge, California 91324
United States
Research Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida 33134
United States
Gastro Health Research - Miami
Miami, Florida 33176
United States
Orlando Health
Orlando, Florida 32806
United States
Digestive and Liver Center of Florida
Orlando, Florida 32825
United States
Gastro Health Research - Pensacola
Pensacola, Florida 32504
United States
Precision Clinical Research
Sunrise, Florida 33351
United States
Grand Teton Research Group
Idaho Falls, Idaho 83404
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
Indiana University Health University Hospital
Indianapolis, Indiana 46202
United States
Gastroenterology Health Partners
New Albany, Indiana 47150
United States
Gastroenterology Health Partners
Louisville, Kentucky 40218
United States
Care Access - New Iberia
New Iberia, Louisiana 70560
United States
Louisiana Research Center
Shreveport, Louisiana 71105
United States
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland 20815
United States
Lucida Clinical Trials
New Bedford, Massachusetts 02740
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
New York Gastroenterology Associates
New York, New York 10075
United States
Care Access - Yonkers
Yonkers, New York 10701
United States
Coastal Research Institute - Fayetteville
Fayetteville, North Carolina 28304
United States
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio 44145
United States
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania 19107
United States
University Gastroenterology
Providence, Rhode Island 02905
United States
Gastroenterology Associates - Patewood
Greenville, South Carolina 29607
United States
Gastroenterology Center Of The Midsouth
Cordova, Tennessee 38018
United States
Gastroenterology Research of San Antonio
San Antonio, Texas 78229
United States
Southern Star Research Institute
San Antonio, Texas 78229
United States
Tyler Research Institute
Tyler, Texas 75701
United States
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia 24014
United States
Washington Gastroenterology - Tacoma
Tacoma, Washington 98405
United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin 53215
United States
Medizinische Universität Graz
Graz, 8036
Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020
Austria
Medizinische Universität Wien
Vienna, 1090
Austria
AZORG Campus Aalst-Moorselbaan
Aalst, 9300
Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, 1070
Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, 8500
Belgium
UZ Leuven
Leuven, 3000
Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
Belgium
Clinical Chc Montlégia
Liège, 4000
Belgium
NewData Clinical Research - Aracaju
Aracaju, 49075-000
Brazil
L2IP - Instituto de Pesquisas Clínicas
Brasília, 70200730
Brazil
Loema Instituto de Pesquisa Clinica
Campinas, 13092-133
Brazil
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, 95070-560
Brazil
Centro Digestivo de Curitiba
Curitiba, 80430-180
Brazil
Galileo Medical Research
Juiz de Fora, 36033-318
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903
Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, 14051-140
Brazil
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador, 41500-300
Brazil
Pesquisare Saude
Santo André, 09080-110
Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000
Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
Brazil
Clínica Hepatogastro JK
São Paulo, 04543-011
Brazil
CEDOES
Vitória, 29055450
Brazil
Integral Pesquisa e Ensino
Votuporanga, 15500-269
Brazil
University Hospital "St. Ivan Rilski"
Gorna Oryahovitsa, 5100
Bulgaria
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
Sofia, 1233
Bulgaria
London Health Sciences Centre
London, N6A 5W9
Canada
London Digestive Disease Institute
London, N6K 1M6
Canada
Clinique IMD
Montreal, H3H 1E8
Canada
The Ottawa Hospital - General Campus
Ottawa, K1H 8L6
Canada
Vancouver General Hospital
Vancouver, V5Z 1M9
Canada
(G.I.R.I.) GI Research Institute Foundation
Vancouver, V5Z 2K5
Canada
SurGal Clinic
Brno, 602 00
Czechia
Gastroenterologie
Hradec Králové, 500 02
Czechia
EndoArt
Ostrava, 710 00
Czechia
ResTrial GastroEndo s.r.o
Prague, 143 00
Czechia
ISCARE klinické centrum
Prague, 19000
Czechia
Masarykova Nemocnice V Usti Nad Labem
Ústí nad Labem, 40113
Czechia
Aarhus Universitetshospital, Skejby
Aarhus, 8200
Denmark
Rigshospitalet
Copenhagen, 2100
Denmark
Herlev and Gentofte Hospital
Copenhagen, 2730
Denmark
Aalborg Universitetshospital, Syd
Gistrup, 9260
Denmark
Odense Universitetshospital
Odense, 5000
Denmark
Vejle Sygehus
Vejle, 7100
Denmark
Clinique des Cèdres
Échirolles, 38130
France
CHD Vendee
La Roche-sur-Yon, 85000
France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
France
Chu Saint Eloi
Montpellier, 34295
France
Centres Médico Chirurgicaux - Clinique Ambroise Paré
Neuilly-sur-Seine, 92200
France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, 06202
France
Hôpital Saint Antoine
Paris, 75571
France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270
France
CHU Rangueil
Toulouse, 31059
France
Clinique Pasteur
Toulouse, 31076
France
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, 60590
Germany
Praxiszentrum für Gastroenterologie
Grevenbroich, 41515
Germany
Studiengesellschaft BSF Unternehmergesellschaft
Halle, 06108
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
Eugastro GmbH
Leipzig, 04103
Germany
Klinikum Ernst von Bergmann
Potsdam, 14467
Germany
Evangelismos General Hospital of Athens
Athens, 106 76
Greece
Thoracic General Hospital of Athens "I Sotiria"
Athens, 115 27
Greece
University General Hospital of Heraklion
Heraklion, 711 10
Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, 54642
Greece
Semmelweis Egyetem
Budapest, 1082
Hungary
Semmelweis Egyetem
Budapest, 1088
Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6725
Hungary
CLINFAN Szolgáltató Kft
Szekszárd, 7100
Hungary
Assuta Ashdod Medical Center
Ashdod, 7747629
Israel
Rambam Health Care Campus
Haifa, 3109601
Israel
Edith Wolfson Medical Center
Holon, 5810001
Israel
Shaare Zedek Medical Center
Jerusalem, 9103102
Israel
Rabin Medical Center
Petah Tikva, 4941492
Israel
Sheba Medical Center
Ramat Gan, 5262100
Israel
Sourasky Medical Center
Tel Aviv, 6423906
Israel
Yitzhak Shamir Medical Center
Ẕerifin, 7033001
Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138
Italy
Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
Castellana Grotte, 70013
Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
Italy
Ospedale San Raffaele
Milan, 20132
Italy
Azienda Ospedale - Università Padova
Padova, 35128
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
Italy
Ospedale Di Circolo
Rho, 20017
Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Italy
Humanitas
Rozzano, 20089
Italy
San Peregrino Unidad de Investigación
Aguascalientes, 20230
Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207
Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, 89440
Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000
Mexico
Boca Clinical Trials Mexico S.C.
Guadajalara, 44600
Mexico
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara, 44340
Mexico
Hospital General de Occidente
Guadalajara, 45170
Mexico
Health Pharma Querétaro
Juriquilla, 76230
Mexico
Centro de Investigación Clinica Chapultepec
Mexico City, 04100
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Mexico
Medical Care and Research SA de CV
Mérida, 97070
Mexico
Servicios de Oncología Médica Integral - Monterrey
Monterrey, 66220
Mexico
Centro de Investigacion Clinica Chapultepec
Morelia, 58260
Mexico
Boca Clinical Trials Mexico SC
Puebla City, 72160
Mexico
Clinical Research Institute S.C.
Tlalnepantla, 54055
Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900
Mexico
Amsterdam UMC, locatie VUmc
Amsterdam, 1081 HZ
Netherlands
Radboudumc
Nijmegen, 6525 GA
Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Netherlands
Ikazia Ziekenhuis
Rotterdam, 3083 AN
Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Netherlands
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600
Poland
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45-819
Poland
IRMED
Piotrkow Trybunalski, 97-300
Poland
Twoja Przychodnia PCM
Poznan, 60-324
Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan, 60-354
Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302
Poland
Twoja Przychodnia SCM
Szczecin, 71-434
Poland
NZOZ GynCentrum - Oddział Warszawa
Warsaw, 00-124
Poland
Vivamed Sp. z o.o.
Warsaw, 03-580
Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, 04-501
Poland
Melita Medical
Wroclaw, 53-611
Poland
ETG Zamość
Zamość, 22-400
Poland
CMRC Headlands, LLC
San Juan, 00918
Puerto Rico
Spitalul Județean de Urgență Bacău
Bacau, 600114
Romania
Spitalul Clinic Colentina
Bucharest, 020125
Romania
Spitalul Universitar de Urgență București
Bucharest, 050098
Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, 900591
Romania
Spitalul Clinic Județean de Urgență
Craiova, 200642
Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, 300002
Romania
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, 97517
Slovakia
Cliniq s.r.o.
Bratislava, 81109
Slovakia
ENDOMED
Košice, 040 13
Slovakia
Gastro LM
Prešov, 080 01
Slovakia
Centro Médico Teknon
Barcelona, 08022
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide
Ferrol, 15405
Spain
Hospital de Cabueñes
Gijón, 33394
Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28028
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Universitario Central de Asturias
Oviedo, 33011
Spain
Complejo Hospitalario de Navarra
Pamplona, 31009
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain
Gazi University Health Research and Application Center Gazi Hospital
Ankara, 06560
Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100
Turkey (Türkiye)
Uludag Universitesi
Bursa, 16059
Turkey (Türkiye)
Eskisehir Osmangazi University
Eskişehir, 26480
Turkey (Türkiye)
Mustafa Kemal Universitesi
Hatay, 31030
Turkey (Türkiye)
Bezmialem Vakf Üniversitesi
Istanbul, 34093
Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, 35100
Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
İzmit, 41380
Turkey (Türkiye)
Mersin University
Mersin, 33110
Turkey (Türkiye)
Southmead Hospital
Bristol, BS10 5NB
United Kingdom
Ninewells Hospital and Medical School
Dundee, DD1 9SY
United Kingdom
Royal Devon & Exeter Hospital
Exeter, EX2 5DW
United Kingdom
Royal London Hospital
London, E1 2AJ
United Kingdom