Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
NCT ID: NCT06937099
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
290 participants
INTERVENTIONAL
2025-06-26
2028-05-31
Brief Summary
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The maximum duration of this study is up to 61 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mirikizumab + Tirzepatide
Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC).
Tirzepatide administered SC.
Mirikizumab
Administered IV
Mirikizumab
Administered SC
Tirzepatide
Administered SC
Mirikizumab + Placebo
Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Mirikizumab
Administered IV
Mirikizumab
Administered SC
Placebo
Administered SC
Interventions
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Mirikizumab
Administered IV
Mirikizumab
Administered SC
Tirzepatide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Digestive Health Specialists
Dothan, Alabama, United States
Smart Cures Clinical Research
Anaheim, California, United States
Cedars-Sinai Medical Center
Beverly Hills, California, United States
United Medical Doctors - Los Alamitos
Los Alamitos, California, United States
California Medical Research Associates
Northridge, California, United States
Research Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida, United States
Gastro Health Research - Miami
Miami, Florida, United States
Orlando Health
Orlando, Florida, United States
Digestive and Liver Center of Florida
Orlando, Florida, United States
Gastro Health Research - Pensacola
Pensacola, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Grand Teton Research Group
Idaho Falls, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Gastroenterology Health Partners
New Albany, Indiana, United States
Gastroenterology Health Partners
Louisville, Kentucky, United States
Care Access - New Iberia
New Iberia, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, United States
Lucida Clinical Trials
New Bedford, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Gastroenterology Associates
New York, New York, United States
Care Access - Yonkers
Yonkers, New York, United States
Coastal Research Institute - Fayetteville
Fayetteville, North Carolina, United States
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, United States
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania, United States
University Gastroenterology - Providence - West River Street
Providence, Rhode Island, United States
Gastroenterology Associates - Patewood
Greenville, South Carolina, United States
Gastroenterology Center Of The Midsouth
Cordova, Tennessee, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, United States
Southern Star Research Institute
San Antonio, Texas, United States
Tyler Research Institute
Tyler, Texas, United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Medizinische Universität Graz
Graz, , Austria
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Medizinische Universität Wien
Vienna, , Austria
AZORG Campus Aalst-Moorselbaan
Aalst, , Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, , Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, , Belgium
Clinical Chc Montlégia
Liège, , Belgium
NewData Clinical Research - Aracaju
Aracaju, , Brazil
L2IP - Instituto de Pesquisas Clínicas
Brasília, , Brazil
Loema Instituto de Pesquisa Clinica
Campinas, , Brazil
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, , Brazil
Centro Digestivo de Curitiba
Curitiba, , Brazil
Galileo Medical Research
Juiz de Fora, , Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, , Brazil
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador, , Brazil
Pesquisare Saude
Santo André, , Brazil
CPQuali Pesquisa Clínica
São Paulo, , Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, , Brazil
Clínica Hepatogastro JK
São Paulo, , Brazil
CEDOES
Vitória, , Brazil
Integral Pesquisa e Ensino
Votuporanga, , Brazil
University Hospital "St. Ivan Rilski"
Gorna Oryahovitsa, , Bulgaria
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
Sofia, , Bulgaria
Gastroenterology and internal medicine research institute
Edmonton, , Canada
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London, , Canada
London Digestive Disease Institute
London, , Canada
Clinique IMD
Montreal, , Canada
Vancouver General Hospital
Vancouver, , Canada
(G.I.R.I.) GI Research Institute Foundation
Vancouver, , Canada
SurGal Clinic
Brno, , Czechia
Gastroenterologie
Hradec Králové, , Czechia
EndoArt
Ostrava, , Czechia
ResTrial GastroEndo s.r.o
Prague, , Czechia
ISCARE klinické centrum
Prague, , Czechia
Masarykova Nemocnice V Usti Nad Labem
Ústí nad Labem, , Czechia
Aalborg Universitetshospital, Syd
Aalborg, , Denmark
Aarhus Universitetshospital, Skejby
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev and Gentofte Hospital
Copenhagen, , Denmark
Vejle Sygehus
Vejle, , Denmark
Clinique des Cèdres
Échirolles, , France
CHD Vendee
La Roche-sur-Yon, , France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Chu Saint Eloi
Montpellier, , France
Centres Médico Chirurgicaux - Clinique Ambroise Paré
Neuilly-sur-Seine, , France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, , France
Hôpital Saint Antoine
Paris, , France
CHU Charles Nicolle
Rouen, , France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez, , France
CHU Rangueil
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, , Germany
Praxiszentrum für Gastroenterologie
Grevenbroich, , Germany
Studiengesellschaft BSF Unternehmergesellschaft
Halle, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Eugastro GmbH
Leipzig, , Germany
Klinikum Ernst von Bergmann
Potsdam, , Germany
Evangelismos General Hospital of Athens
Athens, , Greece
Thoracic General Hospital of Athens "I Sotiria"
Athens, , Greece
University General Hospital of Heraklion
Heraklion, , Greece
University Hospital of Ioannina
Ioannina, , Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, , Greece
Semmelweis Egyetem
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, , Hungary
CLINFAN Szolgáltató Kft
Szekszárd, , Hungary
Assuta Ashdod Medical Center
Ashdod, , Israel
Rambam Health Care Campus
Haifa, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Yitzhak Shamir Medical Center
Ẕerifin, , Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, , Italy
Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
Castellana Grotte, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Azienda Ospedale - Università Padova
Padua, , Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
Palermo, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Ospedale Di Circolo
Rho, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Humanitas
Rozzano, , Italy
San Peregrino Unidad de Investigación
Aguascalientes, , Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, , Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, , Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, , Mexico
Boca Clinical Trials Mexico S.C.
Guadajalara, , Mexico
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara, , Mexico
Hospital General de Occidente
Guadalajara, , Mexico
Health Pharma Querétaro
Juriquilla, , Mexico
Centro de Investigación Clinica Chapultepec
Mexico City, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, , Mexico
Medical Care and Research SA de CV
Mérida, , Mexico
Servicios de Oncología Médica Integral - Monterrey
Monterrey, , Mexico
Centro de Investigacion Clinica Chapultepec
Morelia, , Mexico
Boca Clinical Trials Mexico SC
Puebla City, , Mexico
Clinical Research Institute S.C.
Tlalnepantla, , Mexico
FAICIC S. de R.L. de C.V.
Veracruz, , Mexico
Amsterdam UMC, locatie VUmc
Amsterdam, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Medrise Sp. z o.o.
Lublin, , Poland
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, , Poland
IRMED
Piotrkow Trybunalski, , Poland
Twoja Przychodnia PCM
Poznan, , Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan, , Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, , Poland
Twoja Przychodnia SCM
Szczecin, , Poland
NZOZ GynCentrum - Oddział Warszawa
Warsaw, , Poland
Vivamed Sp. z o.o.
Warsaw, , Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, , Poland
Melita Medical
Wroclaw, , Poland
ETG Zamość
Zamość, , Poland
Caribbean Medical Research Center
San Juan, , Puerto Rico
Spitalul Județean de Urgență Bacău
Bacau, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Spitalul Universitar de Urgență București
Bucharest, , Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, , Romania
Spitalul Clinic Județean de Urgență
Craiova, , Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, , Romania
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, , Slovakia
Cliniq s.r.o.
Bratislava, , Slovakia
ENDOMED
Košice, , Slovakia
Gastro LM
Prešov, , Slovakia
Centro Médico Teknon
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide
Ferrol, , Spain
Hospital Galdakao-Usansolo
Galdakao, , Spain
Hospital de Cabueñes
Gijón, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Gazi University Health Research and Application Center Gazi Hospital
Ankara, , Turkey (Türkiye)
Uludag Universitesi
Bursa, , Turkey (Türkiye)
Eskisehir Osmangazi University
Eskişehir, , Turkey (Türkiye)
Mustafa Kemal Universitesi
Hatay, , Turkey (Türkiye)
Bezmialem Vakf Üniversitesi
Istanbul, , Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, , Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
İzmit, , Turkey (Türkiye)
Mersin University
Mersin, , Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Muratpaşa, , Turkey (Türkiye)
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
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Related Links
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Related Info
Other Identifiers
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2024-520210-21-00
Identifier Type: CTIS
Identifier Source: secondary_id
I6T-MC-AMCE
Identifier Type: OTHER
Identifier Source: secondary_id
27281
Identifier Type: -
Identifier Source: org_study_id
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