Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight (COMMIT-CD)

June 2, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medizinische Universitat Graz
        • Principal Investigator:
          • Christoph Hoegenauer
      • Innsbruck, Austria, 6020
        • Recruiting
        • Medizinische Universitaet Innsbruck
        • Principal Investigator:
          • Robert Koch
        • Contact:
          • Phone Number: 4351250481311
      • Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universitat Wien
        • Principal Investigator:
          • Walter Reinisch
        • Contact:
          • Phone Number: 004314040062450
  • Belgium
      • Aalst, Belgium, 9300
        • Recruiting
        • AZORG Campus Aalst-Moorselbaan
        • Contact:
          • Phone Number: 053 72 44 28
        • Principal Investigator:
          • Stijn Vanden Branden
      • Brussels, Belgium, 1070
        • Recruiting
        • Université Libre de Bruxelles - Hôpital Erasme
        • Principal Investigator:
          • Denis Franchimont
        • Contact:
          • Phone Number: 003225555422
      • Kortrijk, Belgium, 8500
        • Recruiting
        • AZ Groeninge Campus Kennedylaan
        • Contact:
          • Phone Number: +32 56 63 33 00
        • Principal Investigator:
          • Wouter Van Moerkercke
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Phone Number: +3216348856
        • Principal Investigator:
          • João Guedelha Sabino
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
        • Contact:
          • Phone Number: +3243237256
        • Principal Investigator:
          • Edouard Louis
      • Liège, Belgium, 4000
        • Recruiting
        • Clinical Chc Montlégia
        • Principal Investigator:
          • Arnaud Colard
        • Contact:
          • Phone Number: +3243554211
  • Brazil
      • Aracaju, Brazil, 49075-000
        • Recruiting
        • NewData Clinical Research - Aracaju
        • Principal Investigator:
          • Alex Callado França
        • Contact:
          • Phone Number: +55 79 98825-9395
      • Brasília, Brazil, 70200730
        • Recruiting
        • L2IP - Instituto de Pesquisas Clínicas
        • Contact:
          • Phone Number: 6134454300
        • Principal Investigator:
          • Luciana Teixeira de Campos
      • Campinas, Brazil, 13092-133
        • Recruiting
        • Loema Instituto de Pesquisa Clinica
        • Principal Investigator:
          • Joaquim Simoes Neto
        • Contact:
          • Phone Number: 19 3252-5611
      • Caxias do Sul, Brazil, 95070-560
        • Recruiting
        • Fundação Universidade de Caxias do Sul (FUCS)
        • Principal Investigator:
          • Eduardo Brambilla
      • Curitiba, Brazil, 80430-180
        • Recruiting
        • Centro Digestivo de Curitiba
        • Contact:
          • Phone Number: +55 41 3322-1115
        • Principal Investigator:
          • Odery Ramos Júnior
      • Juiz de Fora, Brazil, 36033-318
        • Recruiting
        • Galileo Medical Research
        • Principal Investigator:
          • Julio Chebli
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Hospital De Clinicas De Porto Alegre
        • Contact:
          • Phone Number: +5551999199815
        • Principal Investigator:
          • Luciana Harlacher
      • Ribeirão Preto, Brazil, 14051-140
        • Recruiting
        • Hospital de Clínicas de Ribeirão Preto
        • Principal Investigator:
          • Rogerio Parra
        • Contact:
          • Phone Number: 1636022283
      • Salvador, Brazil, 41500-300
        • Recruiting
        • CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
        • Contact:
          • Phone Number: 55 71 99957 2121
        • Principal Investigator:
          • Genoile Silva
      • Santo André, Brazil, 09080-110
        • Recruiting
        • Pesquisare Saude
        • Principal Investigator:
          • ALEXANDER DE SA ROLIM
      • São Paulo, Brazil, 01228-000
        • Recruiting
        • CPQuali Pesquisa Clínica
        • Principal Investigator:
          • Alexandre de Sousa Carlos
        • Contact:
          • Phone Number: +55 11 2776-6801
      • São Paulo, Brazil, 04266-010
        • Recruiting
        • CEPIC - Centro Paulista de Investigação Clínica
        • Principal Investigator:
          • Renata Lamanna
      • São Paulo, Brazil, 04543-011
        • Recruiting
        • Clínica Hepatogastro JK
        • Principal Investigator:
          • Rodrigo Andrey Rocco
        • Contact:
          • Phone Number: 5511999158070
      • Vitória, Brazil, 29055450
        • Recruiting
        • CEDOES
        • Principal Investigator:
          • Felipe Ferreira
        • Contact:
          • Phone Number: 5527988393435
      • Votuporanga, Brazil, 15500-269
        • Recruiting
        • INTEGRAL Pesquisa e Ensino
        • Principal Investigator:
          • HERLON VALÉRIO
        • Contact:
          • Phone Number: +5517997472217
  • Bulgaria
      • Gorna Oryahovitsa, Bulgaria, 5100
        • Recruiting
        • University Hospital "St. Ivan Rilski"
        • Principal Investigator:
          • Ilko Kosturkov
      • Sofia, Bulgaria, 1527
        • Not yet recruiting
        • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
        • Principal Investigator:
          • Plamen Penchev
      • Sofia, Bulgaria, 1233
        • Not yet recruiting
        • Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
        • Principal Investigator:
          • Nikolay Tsonev
  • Canada
      • Edmonton, Canada, T5R 1W2
        • Not yet recruiting
        • Gastroenterology and internal medicine research institute
        • Principal Investigator:
          • Allen Lim
        • Contact:
          • Phone Number: 7804991192
      • London, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre
        • Contact:
          • Phone Number: 519-685-8500
        • Principal Investigator:
          • Terry Ponich
      • London, Canada, N6K 1M6
        • Recruiting
        • London Digestive Disease Institute
        • Principal Investigator:
          • Vipul Jairath
      • Montreal, Canada, H3H 1E8
        • Recruiting
        • Clinique IMD
        • Principal Investigator:
          • Waqqas Afif
        • Contact:
          • Phone Number: 514-798-0550
      • Ottawa, Canada, K1H 8L6
        • Not yet recruiting
        • The Ottawa Hospital - General Campus
        • Principal Investigator:
          • Jeffrey McCurdy
      • Vancouver, Canada, V5Z 1M9
        • Not yet recruiting
        • Vancouver General Hospital
        • Principal Investigator:
          • Sundeep Singh
      • Vancouver, Canada, V5Z 2K5
        • Not yet recruiting
        • (G.I.R.I.) GI Research Institute Foundation
        • Principal Investigator:
          • Greg Rosenfeld
  • Czechia
      • Brno, Czechia, 602 00
        • Recruiting
        • SurGal Clinic
        • Principal Investigator:
          • Jan Ulbrych
      • Hradec Králové, Czechia, 500 02
        • Recruiting
        • Gastroenterologie
        • Contact:
          • Phone Number: +420607142114
        • Principal Investigator:
          • Milan Siroky
      • Ostrava, Czechia, 710 00
        • Recruiting
        • EndoArt
        • Principal Investigator:
          • Radka Koskova
        • Contact:
          • Phone Number: 00420602110107
      • Prague, Czechia, 143 00
        • Recruiting
        • ResTrial GastroEndo s.r.o
        • Principal Investigator:
          • Ludek Hrdlicka
      • Prague, Czechia, 19000
        • Recruiting
        • ISCARE klinické centrum
        • Principal Investigator:
          • Milan Lukas
        • Contact:
          • Phone Number: +420 725 505 279
      • Ústí nad Labem, Czechia, 40113
        • Recruiting
        • Masarykova Nemocnice V Usti Nad Labem
        • Principal Investigator:
          • Michal Tichy
        • Contact:
          • Phone Number: 420477112450
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby
        • Principal Investigator:
          • Anders Dige
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Principal Investigator:
          • Anja Poulsen
      • Copenhagen, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital
        • Principal Investigator:
          • Jacob Bjerrum
        • Contact:
          • Phone Number: 0045 38681848
      • Gistrup, Denmark, 9260
        • Recruiting
        • Aalborg Universitetshospital, Syd
        • Principal Investigator:
          • Jan Fallingborg
        • Contact:
          • Phone Number: +4597663560
      • Odense, Denmark, 5000
        • Not yet recruiting
        • Odense Universitetshospital
        • Principal Investigator:
          • Jens Kjeldsen
      • Vejle, Denmark, 7100
        • Recruiting
        • Vejle Sygehus
        • Principal Investigator:
          • Maiken Jørgensen
  • France
      • La Roche-sur-Yon, France, 85000
        • Recruiting
        • CHD Vendee
        • Principal Investigator:
          • Astrid De Maissin
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
        • Principal Investigator:
          • Aurelien Amiot
      • Montpellier, France, 34295
        • Recruiting
        • Chu Saint Eloi
        • Contact:
          • Phone Number: 33467330224
        • Principal Investigator:
          • Anne Bozon
      • Neuilly-sur-Seine, France, 92200
        • Recruiting
        • Centres Médico Chirurgicaux - Clinique Ambroise Paré
        • Principal Investigator:
          • Xavier Treton
        • Contact:
          • Phone Number: 01 41 43 05 73
      • Nice, France, 06202
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
        • Principal Investigator:
          • Stephane Schneider
        • Contact:
          • Phone Number: 33492039367
      • Paris, France, 75571
        • Recruiting
        • Hopital Saint Antoine
        • Principal Investigator:
          • Julien Kirchgesner
      • Rouen, France, 76031
        • Recruiting
        • CHU Charles Nicolle
        • Principal Investigator:
          • Nicolas RICHARD
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord
        • Principal Investigator:
          • Mathilde Barrau
      • Toulouse, France, 31059
        • Recruiting
        • CHU Rangueil
        • Principal Investigator:
          • cyrielle Gilletta
      • Toulouse, France, 31076
        • Not yet recruiting
        • Clinique Pasteur
        • Principal Investigator:
          • Patrick Faure
      • Échirolles, France, 38130
        • Recruiting
        • Clinique des Cèdres
        • Principal Investigator:
          • Nicolas MATHIEU
  • Germany
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt Goethe-Universität
        • Principal Investigator:
          • Irina Blumenstein
        • Contact:
          • Phone Number: 069630187769
      • Grevenbroich, Germany, 41515
        • Recruiting
        • Praxiszentrum für Gastroenterologie
        • Contact:
          • Phone Number: 02181475930
        • Principal Investigator:
          • Axel Naumann
      • Halle, Germany, 06108
        • Recruiting
        • Studiengesellschaft BSF Unternehmergesellschaft
        • Contact:
          • Phone Number: 00493452997626
        • Principal Investigator:
          • Lars Fechner
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Ursula Seidler
        • Contact:
          • Phone Number: 05115329427
      • Leipzig, Germany, 04103
        • Recruiting
        • Eugastro GmbH
        • Principal Investigator:
          • Ingolf Schiefke
        • Contact:
          • Phone Number: 00493414935720
      • Potsdam, Germany, 14467
        • Recruiting
        • Klinikum Ernst von Bergmann
        • Principal Investigator:
          • Daniel Baumgart
        • Contact:
          • Phone Number: 004933124136202
  • Greece
      • Athens, Greece, 106 76
        • Recruiting
        • Evangelismos General Hospital of Athens
        • Principal Investigator:
          • NIKOLAOS VIAZIS
      • Athens, Greece, 115 27
        • Recruiting
        • Thoracic General Hospital of Athens "I Sotiria"
        • Principal Investigator:
          • Giorgos Bamias
        • Contact:
          • Phone Number: +306976062713
      • Heraklion, Greece, 711 10
        • Recruiting
        • University General Hospital of Heraklion
        • Principal Investigator:
          • Ioannis Koutroubakis
        • Contact:
          • Phone Number: 2810392037
      • Thessaloniki, Greece, 54642
        • Recruiting
        • Ippokrateio General Hospital of Thessaloniki
        • Principal Investigator:
          • OLGA GIOULEME
  • Hungary
      • Budapest, Hungary, 1088
        • Recruiting
        • Semmelweis Egyetem
        • Principal Investigator:
          • Zsolt Tulassay
        • Contact:
          • Phone Number: 3612664616
      • Budapest, Hungary, 1082
        • Recruiting
        • Semmelweis Egyetem
        • Principal Investigator:
          • Pal Miheller
        • Contact:
          • Phone Number: 0036208250460
      • Szeged, Hungary, 6725
        • Recruiting
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
        • Principal Investigator:
          • Tamas Molnar
      • Szekszárd, Hungary, 7100
        • Recruiting
        • CLINFAN Szolgáltató Kft
        • Principal Investigator:
          • Agnes Salamon
        • Contact:
          • Phone Number: +36302777114
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • Assuta Ashdod Medical Center
        • Principal Investigator:
          • Adi Lahat-Zok
        • Contact:
          • Phone Number: +9720723398277
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
          • Phone Number: 972-4-7772850
        • Principal Investigator:
          • Roni Weisshof
      • Holon, Israel, 5810001
        • Recruiting
        • Edith Wolfson Medical Center
        • Principal Investigator:
          • Eran Israeli
        • Contact:
          • Phone Number: 97235028500
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
          • Phone Number: +972 26666916
        • Principal Investigator:
          • Benjamin Koslowsky
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
        • Contact:
          • Phone Number: +97239377241 (5)
        • Principal Investigator:
          • Irit Avni-Biron
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Asaf Levartovsky
        • Contact:
          • Phone Number: 0523894508
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center
        • Contact:
          • Phone Number: +97236973011
        • Principal Investigator:
          • Nathaniel Cohen
      • Ẕerifin, Israel, 7033001
        • Recruiting
        • Yitzhak Shamir Medical Center
        • Principal Investigator:
          • EFRAT BROIDE
        • Contact:
          • Phone Number: 972-8-934-9793
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
        • Contact:
          • Phone Number: 0512145312
        • Principal Investigator:
          • Fernando Rizzello
      • Castellana Grotte, Italy, 70013
        • Recruiting
        • Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
        • Principal Investigator:
          • Mauro Mastronardi
        • Contact:
          • Phone Number: +39 0804994379
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
        • Principal Investigator:
          • Flavio Caprioli
        • Contact:
          • Phone Number: 0255032141
      • Milan, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele
        • Principal Investigator:
          • Silvio Danese
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedale - Università Padova
        • Contact:
          • Phone Number: +390498217749
        • Principal Investigator:
          • Edoardo Savarino
      • Palermo, Italy, 90146
        • Not yet recruiting
        • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
        • Principal Investigator:
          • Ambrogio Orlando
        • Contact:
          • Phone Number: +390916802022
      • Pisa, Italy, 56124
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
          • Phone Number: 050997405
        • Principal Investigator:
          • Francesco Costa
      • Rho, Italy, 20017
        • Recruiting
        • Ospedale Di Circolo
        • Principal Investigator:
          • Simone Saibeni
        • Contact:
          • Phone Number: 02 99430.3264
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli
        • Principal Investigator:
          • Franco Scaldaferri
        • Contact:
          • Phone Number: 0630154678
      • Rozzano, Italy, 20089
        • Recruiting
        • Humanitas
        • Principal Investigator:
          • Alessandro Armuzzi
        • Contact:
          • Phone Number: 0282243263
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Not yet recruiting
        • San Peregrino Unidad de Investigación
        • Contact:
          • Phone Number: 4493776500
        • Principal Investigator:
          • Jovanni Toca Villegas
      • Chihuahua City, Mexico, 31207
        • Recruiting
        • Scientia Investigacion Clinica S.C.
        • Principal Investigator:
          • Karina Ramirez
      • Ciudad Madero, Mexico, 89440
        • Recruiting
        • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
        • Principal Investigator:
          • Korely Trujillo
      • Durango, Mexico, 34000
        • Not yet recruiting
        • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
        • Principal Investigator:
          • LUIS CARLOS DIAZ HERRERA
      • Guadajalara, Mexico, 44600
        • Recruiting
        • Boca Clinical Trials Mexico S.C.
        • Contact:
          • Phone Number: 3338306672
        • Principal Investigator:
          • Christian Jaramillo Buendía
      • Guadalajara, Mexico, 44340
        • Not yet recruiting
        • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
        • Contact:
          • Phone Number: +52 3339869435
        • Principal Investigator:
          • Jesús Alonso Valenzuela Pérez
      • Guadalajara, Mexico, 45170
        • Not yet recruiting
        • Hospital General de Occidente
        • Principal Investigator:
          • Ana Turrado
      • Juriquilla, Mexico, 76230
        • Not yet recruiting
        • Health Pharma Querétaro
        • Principal Investigator:
          • Amador Garcia
      • Mexico City, Mexico, 04100
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Principal Investigator:
          • Elda Rodriguez Negrete
      • Mexico City, Mexico, 14080
        • Not yet recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Principal Investigator:
          • JESUS YAMAMOTO-FURUSHO
      • Monterrey, Mexico, 66220
        • Recruiting
        • Servicios de Oncología Médica Integral - Monterrey
        • Principal Investigator:
          • Manuel Martinez Vazquez
      • Morelia, Mexico, 58260
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Contact:
          • Phone Number: 4431478545
        • Principal Investigator:
          • Araceli Muñoz Bautista
      • Mérida, Mexico, 97070
        • Recruiting
        • Medical Care and Research SA de CV
        • Principal Investigator:
          • AXEL MENA QUINTERO
      • Puebla City, Mexico, 72160
        • Recruiting
        • Boca Clinical Trials Mexico SC
        • Contact:
          • Phone Number: 2229736952
        • Principal Investigator:
          • Elias Ballesteros Suarez
      • Tlalnepantla, Mexico, 54055
        • Recruiting
        • Clinical Research Institute S.C.
        • Contact:
          • Phone Number: 52 55 53627780
        • Principal Investigator:
          • Leticia Marin
      • Veracruz, Mexico, 91900
        • Not yet recruiting
        • FAICIC S. de R.L. de C.V.
        • Principal Investigator:
          • Aracely Cruz Palacios
        • Contact:
          • Phone Number: 2299327808
  • Netherlands
      • Amsterdam, Netherlands, 1081 HZ
        • Recruiting
        • Amsterdam UMC, locatie VUmc
        • Contact:
          • Phone Number: 31205666545
        • Principal Investigator:
          • Mark Lowenberg
      • Nijmegen, Netherlands, 6525 GA
        • Not yet recruiting
        • Radboudumc
        • Principal Investigator:
          • Marjolijn Duijvestein
        • Contact:
          • Phone Number: +31 24 3619190
      • Rotterdam, Netherlands, 3083 AN
        • Recruiting
        • Ikazia Ziekenhuis
        • Contact:
          • Phone Number: 0102975000
        • Principal Investigator:
          • Geert Bezemer
      • Rotterdam, Netherlands, 3015 GD
        • Not yet recruiting
        • Erasmus Medisch Centrum
        • Contact:
          • Phone Number: +317030792
        • Principal Investigator:
          • Annemarie de Vries
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht
        • Principal Investigator:
          • Herma Fidder
        • Contact:
          • Phone Number: 0031887573618
  • Poland
      • Lublin, Poland, 20-582
        • Recruiting
        • Medrise Sp. z o.o.
        • Principal Investigator:
          • Wit Danilkiewicz
        • Contact:
          • Phone Number: +48 795 404 502
      • Opole, Poland, 45-819
        • Recruiting
        • Twoja Przychodnia Opolskie Centrum Medyczne
        • Contact:
          • Phone Number: 690548825
        • Principal Investigator:
          • Agata Lukawska
      • Piotrkow Trybunalski, Poland, 97-300
        • Recruiting
        • IRMED
        • Principal Investigator:
          • Katarzyna Ostrowska
      • Poznan, Poland, 60-324
        • Recruiting
        • Twoja Przychodnia PCM
        • Contact:
          • Phone Number: +48 724 444 299
        • Principal Investigator:
          • Ewa Furmanowska-Ladorska
      • Poznan, Poland, 60-354
        • Recruiting
        • Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
        • Contact:
          • Phone Number: 618547552
        • Principal Investigator:
          • Piotr Eder
      • Rzeszów, Poland, 35-302
        • Recruiting
        • Korczowski Bartosz, Gabinet Lekarski
        • Principal Investigator:
          • Bartosz Korczowski
        • Contact:
          • Phone Number: 604481752
      • Szczecin, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia SCM
        • Principal Investigator:
          • Beata Gawdis-Wojnarska
        • Contact:
          • Phone Number: 48 91 433 29 19
      • Warsaw, Poland, 04-501
        • Recruiting
        • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
          • Phone Number: 500111648
      • Warsaw, Poland, 00-124
        • Recruiting
        • NZOZ GynCentrum - Oddział Warszawa
        • Principal Investigator:
          • Alina Kurylowicz
      • Warsaw, Poland, 03-580
        • Recruiting
        • Vivamed Sp. z o.o.
        • Principal Investigator:
          • Robert Petryka
        • Contact:
          • Phone Number: 604422988
      • Wroclaw, Poland, 53-611
        • Recruiting
        • Melita Medical
        • Principal Investigator:
          • Jaroslaw Leszczyszyn
        • Contact:
          • Phone Number: 48660551155
      • Zamość, Poland, 22-400
        • Recruiting
        • ETG Zamosc
        • Principal Investigator:
          • Katarzyna Wojcik
        • Contact:
          • Phone Number: 48606930022
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • CMRC Headlands, LLC
        • Principal Investigator:
          • Melvyn Acosta Febo
  • Romania
      • Bacau, Romania, 600114
        • Recruiting
        • Spitalul Județean de Urgență Bacău
        • Contact:
          • Phone Number: 0740182009
        • Principal Investigator:
          • ELENA POPOVICI
      • Bucharest, Romania, 050098
        • Recruiting
        • Spitalul Universitar de Urgenta Bucuresti
        • Principal Investigator:
          • Lucian Negreanu
        • Contact:
          • Phone Number: 0722546405
      • Bucharest, Romania, 020125
        • Recruiting
        • Spitalul Clinic Colentina
        • Principal Investigator:
          • Bogdan Mateescu
        • Contact:
          • Phone Number: 0213152590
      • Constanța, Romania, 900591
        • Recruiting
        • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
        • Principal Investigator:
          • Eugen Dumitru
        • Contact:
          • Phone Number: +40744761454
      • Craiova, Romania, 200642
        • Recruiting
        • Spitalul Clinic Județean de Urgență
        • Contact:
          • Phone Number: 40751268731
        • Principal Investigator:
          • Dan Ionut Gheonea
      • Timișoara, Romania, 300002
        • Recruiting
        • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
        • Principal Investigator:
          • Adrian Goldis
        • Contact:
          • Phone Number: 0040722410712
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • Recruiting
        • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
        • Principal Investigator:
          • Jozef Balaz
        • Contact:
          • Phone Number: 421905838606
      • Bratislava, Slovakia, 81109
        • Recruiting
        • Cliniq s.r.o.
        • Principal Investigator:
          • Tibor Hlavaty
        • Contact:
          • Phone Number: +421917752297
      • Košice, Slovakia, 040 13
        • Recruiting
        • ENDOMED
        • Principal Investigator:
          • Miroslav Fedurco
        • Contact:
          • Phone Number: +421 905 271215
      • Prešov, Slovakia, 080 01
        • Recruiting
        • Gastro LM
        • Principal Investigator:
          • Lubomir Mihalkanin
        • Contact:
          • Phone Number: +421905794001
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Phone Number: +34932746258
        • Principal Investigator:
          • Natalia Borruel
      • Barcelona, Spain, 08022
        • Recruiting
        • Centro Médico Teknon
        • Principal Investigator:
          • Miquel Sans Cuffi
      • Ferrol, Spain, 15405
        • Not yet recruiting
        • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide
        • Contact:
          • Phone Number: 981 336871
        • Principal Investigator:
          • ANA ECHARRI PIUDO
      • Gijón, Spain, 33394
        • Recruiting
        • Hospital de Cabuenes
        • Principal Investigator:
          • Pilar Varela Trastoy
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • MARIA DOLORES MARTIN ARRANZ
      • Madrid, Spain, 28028
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Principal Investigator:
          • Ignacio Marin Jimenez
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Phone Number: 985107878
        • Principal Investigator:
          • Ruth De Francisco
      • Pamplona, Spain, 31009
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • Phone Number: 848422391
        • Principal Investigator:
          • CRISTINA RODRIGUEZ GUTIERREZ
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Principal Investigator:
          • Federico Argüelles-Arias
        • Contact:
          • Phone Number: 0034955008800
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Principal Investigator:
          • Marisa Iborra Colomino
        • Contact:
          • Phone Number: 961244055
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi University Health Research and Application Center Gazi Hospital
        • Principal Investigator:
          • Tarkan Karakan
        • Contact:
          • Phone Number: 0 505 319 22 57
      • Bursa, Turkey (Türkiye), 16059
        • Recruiting
        • Uludag Universitesi
        • Principal Investigator:
          • Macit Gulten
      • Eskişehir, Turkey (Türkiye), 26480
        • Recruiting
        • Eskisehir Osmangazi University
        • Principal Investigator:
          • Tuncer Temel
      • Hatay, Turkey (Türkiye), 31030
        • Not yet recruiting
        • Mustafa Kemal Universitesi
        • Principal Investigator:
          • Mehmet Demir
      • Istanbul, Turkey (Türkiye), 34093
        • Recruiting
        • Bezmialem Vakf Üniversitesi
        • Principal Investigator:
          • Metin Basaranoglu
      • Izmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi
        • Principal Investigator:
          • Nalan Unal
        • Contact:
          • Phone Number: +90 505 782 38 08
      • Mersin, Turkey (Türkiye), 33110
        • Recruiting
        • Mersin University
        • Principal Investigator:
          • Engin Altintas
        • Contact:
          • Phone Number: 905326145276
      • Muratpaşa, Turkey (Türkiye), 07050
        • Not yet recruiting
        • Antalya Egitim ve Arastırma Hastanesi
        • Principal Investigator:
          • Ayhan Hilmi Cekin
      • İzmit, Turkey (Türkiye), 41380
        • Recruiting
        • Kocaeli University Medical Faculty Hospital
        • Principal Investigator:
          • Hasan Yilmaz
        • Contact:
          • Phone Number: 0090 505 877 48 21
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Recruiting
        • Digestive Health Specialists
        • Principal Investigator:
          • Paul Lamb
        • Contact:
          • Phone Number: 334-836-1212
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • Smart Cures Clinical Research
        • Principal Investigator:
          • Dennis Riff
      • Beverly Hills, California, United States, 90211
        • Not yet recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Andres Yarur
        • Contact:
          • Phone Number: 310-423-4100
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • United Medical Doctors - Los Alamitos
        • Contact:
          • Phone Number: 562-430-4449
        • Principal Investigator:
          • Seyedehsan Navabi
      • Northridge, California, United States, 91324
        • Recruiting
        • California Medical Research Associates
        • Principal Investigator:
          • Calin Arimie
        • Contact:
          • Phone Number: 818-349-1979
    • Florida
      • Miami, Florida, United States, 33134
        • Recruiting
        • Research Associates of South Florida - Miami - Southwest 8th Street
        • Principal Investigator:
          • Alexander Veloso
      • Miami, Florida, United States, 33176
        • Recruiting
        • Gastro Health Research - Miami
        • Principal Investigator:
          • Lukasz Kwapisz
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health
        • Principal Investigator:
          • Udayakumar Navaneethan
      • Orlando, Florida, United States, 32825
        • Recruiting
        • Digestive and Liver Center of Florida
        • Contact:
          • Phone Number: 407-384-7388
        • Principal Investigator:
          • Harinath Sheela
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Gastro Health Research - Pensacola
        • Principal Investigator:
          • Frederic Newman
      • Sunrise, Florida, United States, 33351
        • Recruiting
        • Precision Clinical Research
        • Principal Investigator:
          • Jeffrey Schneider
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Grand Teton Research Group
        • Contact:
          • Phone Number: 208-528-4256
        • Principal Investigator:
          • Todd Williams
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Atsushi Sakuraba
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health University Hospital
        • Principal Investigator:
          • Monika Fischer
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Gastroenterology Health Partners
        • Contact:
          • Phone Number: 812-206-1702
        • Principal Investigator:
          • Robert Luckett
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Recruiting
        • Gastroenterology Health Partners
        • Principal Investigator:
          • Michael Krease
        • Contact:
          • Phone Number: 502-888-1988
    • Louisiana
      • New Iberia, Louisiana, United States, 70560
        • Recruiting
        • Care Access - New Iberia
        • Principal Investigator:
          • Son Nguyen
        • Contact:
          • Phone Number: 813-851-0135
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Louisiana Research Center
        • Contact:
          • Phone Number: 318-525-3233
        • Principal Investigator:
          • John Provenza
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Recruiting
        • Capital Digestive Care - Chevy Chase
        • Principal Investigator:
          • Erica Cohen
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Recruiting
        • Lucida Clinical Trials
        • Principal Investigator:
          • Paul Sepe
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Parakkal Deepak
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Medical Center
        • Principal Investigator:
          • Corey Siegel
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • New York Gastroenterology Associates
        • Contact:
          • Phone Number: 212-369-2490
        • Principal Investigator:
          • Arthur Kornbluth
      • Yonkers, New York, United States, 10701
        • Recruiting
        • Care Access - Yonkers
        • Principal Investigator:
          • Peter Wayne
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Recruiting
        • Coastal Research Institute - Fayetteville
        • Principal Investigator:
          • John Poulos
    • Ohio
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • Gastro Intestinal Research Institute of Northern Ohio, LLC
        • Principal Investigator:
          • Mousab Tabbaa
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Medicine/GI and Hepatology
        • Contact:
          • Phone Number: 215-955-8900
        • Principal Investigator:
          • Priya Sehgal
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • University Gastroenterology
        • Principal Investigator:
          • Lisa Mueller
        • Contact:
          • Phone Number: 401-421-8800
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Gastroenterology Associates - Patewood
        • Principal Investigator:
          • Matthew Barnes
        • Contact:
          • Phone Number: 864-451-5026
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Gastroenterology Center Of The Midsouth
        • Principal Investigator:
          • Ziad Younes
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Gastroenterology Research of San Antonio
        • Principal Investigator:
          • Charles Randall
        • Contact:
          • Phone Number: 210-615-3848
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute
        • Contact:
          • Phone Number: 210-581-2812
        • Principal Investigator:
          • Jeff Bullock
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Tyler Research Institute
        • Principal Investigator:
          • George DuVall
        • Contact:
          • Phone Number: 903-630-6211
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Washington Gastroenterology - Tacoma
        • Principal Investigator:
          • William Holderman
        • Contact:
          • Phone Number: 253-272-5127
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Wisconsin Center for Advanced Research
        • Contact:
          • Phone Number: 414-908-6500
        • Principal Investigator:
          • Chetan Mittal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD

  • 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 a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing 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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirikizumab + Tirzepatide

Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC).

Tirzepatide administered SC.
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828
Drug: Mirikizumab
Administered IV
Other Names:
  • LY3074828
Experimental: Mirikizumab + Placebo
Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Drug: Placebo
Administered SC
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828
Drug: Mirikizumab
Administered IV
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
Time Frame: Week 52
Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI
Time Frame: Week 52
Percentage of participants who achieve maintenance of clinical remission by CDAI.
Week 52
Percentage of Participants Who Achieved Maintenance of Endoscopic Remission
Time Frame: Week 52
Percentage of participants who achieve maintenance of endoscopic remission.
Week 52
Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline
Time Frame: Week 52
Percentage of participants who achieve corticosteroid-free clinical remission by CDAI among participants who used corticosteroids at baseline.
Week 52
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: Baseline, Week 52
Change from baseline in inflammatory bowel disease questionnaire (IBDQ).
Baseline, Week 52
Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight
Time Frame: Week 52
Percentage of participants who achieve at least a 10% reduction in body weight.
Week 52
Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission
Time Frame: Week 24, 52
Percentage of participants who simultaneously achieve clinical remission by CDAI and endoscopic remission.
Week 24, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27281
  • 2024-520210-21-00 (Ctis)
  • I6T-MC-AMCE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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