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Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Sponsor: Eli Lilly and Company
Summary
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.
Official title: A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
290
Start Date
2025-06-26
Completion Date
2028-05
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Mirikizumab
Administered IV
Mirikizumab
Administered SC
Tirzepatide
Administered SC
Placebo
Administered SC
Locations (183)
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, 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
Gastroenterology and internal medicine research institute
Edmonton, Canada
London Health Sciences Centre
London, Canada
London Digestive Disease Institute
London, Canada
Clinique IMD
Montreal, Canada
The Ottawa Hospital - General Campus
Ottawa, 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
Aarhus Universitetshospital, Skejby
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev and Gentofte Hospital
Copenhagen, Denmark
Aalborg Universitetshospital, Syd
Gistrup, Denmark
Odense Universitetshospital
Odense, 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
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, Germany
Praxiszentrum für Gastroenterologie
Grevenbroich, Germany
Studiengesellschaft Mitteldeutschland GmbH
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
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Greece
Semmelweis Egyetem
Budapest, Hungary