AzTrials
AzTrials

Crohn's DiseasePhase 3COMMIT-CDNCT06937099

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

A Phase 3 study testing Mirikizumab and Tirzepatide in people with Crohn's Disease and Obesity or Overweight, run by Eli Lilly and Company at 183 sites in 22 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Crohn's Disease, Obesity or Overweight
What is being tested?
Mirikizumab and Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
290 participants
Where
183 sitesin 22 countries
Study dates
26 Jun 2025to May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

183 sites in 22 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

183 sites in 22 countries

United States35 sites, 35 recruiting

  • Smart Cures Clinical Research

    Anaheim, California, 92806

    Dennis Riff

    Recruiting

  • Cedars-Sinai Medical Center

    Beverly Hills, California, 90211

    310-423-4100

    Andres Yarur

    Recruiting

  • Capital Digestive Care - Chevy Chase

    Chevy Chase, Maryland, 20815

    Erica Cohen

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Atsushi Sakuraba

    Recruiting

  • Gastroenterology Center Of The Midsouth

    Cordova, Tennessee, 38018

    Ziad Younes

    Recruiting

  • Digestive Health Specialists

    Dothan, Alabama, 36301

    334-836-1212

    Paul Lamb

    Recruiting

  • Coastal Research Institute - Fayetteville

    Fayetteville, North Carolina, 28304

    John Poulos

    Recruiting

  • Gastroenterology Associates - Patewood

    Greenville, South Carolina, 29607

    864-451-5026

    Matthew Barnes

    Recruiting

  • Grand Teton Research Group

    Idaho Falls, Idaho, 83404

    208-528-4256

    Todd Williams

    Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

    Monika Fischer

    Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Corey Siegel

    Recruiting

  • United Medical Doctors - Los Alamitos

    Los Alamitos, California, 90720

    562-430-4449

    Seyedehsan Navabi

    Recruiting

  • Gastroenterology Health Partners

    Louisville, Kentucky, 40218

    502-888-1988

    Michael Krease

    Recruiting

  • Research Associates of South Florida - Miami - Southwest 8th Street

    Miami, Florida, 33134

    Alexander Veloso

    Recruiting

  • Gastro Health Research - Miami

    Miami, Florida, 33176

    Lukasz Kwapisz

    Recruiting

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

    414-908-6500

    Chetan Mittal

    Recruiting

  • Gastroenterology Health Partners

    New Albany, Indiana, 47150

    812-206-1702

    Robert Luckett

    Recruiting

  • Lucida Clinical Trials

    New Bedford, Massachusetts, 02740

    Paul Sepe

    Recruiting

  • Care Access - New Iberia

    New Iberia, Louisiana, 70560

    813-851-0135

    Son Nguyen

    Recruiting

  • New York Gastroenterology Associates

    New York, New York, 10075

    212-369-2490

    Arthur Kornbluth

    Recruiting

  • California Medical Research Associates

    Northridge, California, 91324

    818-349-1979

    Calin Arimie

    Recruiting

  • Orlando Health

    Orlando, Florida, 32806

    Udayakumar Navaneethan

    Recruiting

  • Digestive and Liver Center of Florida

    Orlando, Florida, 32825

    407-384-7388

    Harinath Sheela

    Recruiting

  • Gastro Health Research - Pensacola

    Pensacola, Florida, 32504

    Frederic Newman

    Recruiting

  • Thomas Jefferson University - Medicine/GI and Hepatology

    Philadelphia, Pennsylvania, 19107

    215-955-8900

    Priya Sehgal

    Recruiting

  • University Gastroenterology

    Providence, Rhode Island, 02905

    401-421-8800

    Lisa Mueller

    Recruiting

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

    210-615-3848

    Charles Randall

    Recruiting

  • Southern Star Research Institute

    San Antonio, Texas, 78229

    210-581-2812

    Jeff Bullock

    Recruiting

  • Louisiana Research Center

    Shreveport, Louisiana, 71105

    318-525-3233

    John Provenza

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Parakkal Deepak

    Recruiting

  • Precision Clinical Research

    Sunrise, Florida, 33351

    Jeffrey Schneider

    Recruiting

  • Washington Gastroenterology - Tacoma

    Tacoma, Washington, 98405

    253-272-5127

    William Holderman

    Recruiting

  • Tyler Research Institute

    Tyler, Texas, 75701

    903-630-6211

    George DuVall

    Recruiting

  • Gastro Intestinal Research Institute of Northern Ohio, LLC

    Westlake, Ohio, 44145

    Mousab Tabbaa

    Recruiting

  • Care Access - Yonkers

    Yonkers, New York, 10701

    Peter Wayne

    Recruiting

Other trials in United States

Mexico16 sites, 16 recruiting

  • San Peregrino Unidad de Investigación

    Aguascalientes, 20230

    4493776500

    Jovanni Toca Villegas

    Not yet recruiting

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207

    Karina Ramirez

    Recruiting

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.

    Ciudad Madero, 89440

    Korely Trujillo

    Recruiting

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000

    LUIS CARLOS DIAZ HERRERA

    Not yet recruiting

  • Boca Clinical Trials Mexico S.C.

    Guadajalara, 44600

    3338306672

    Christian Jaramillo Buendía

    Recruiting

  • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

    Guadalajara, 44340

    +52 3339869435

    Jesús Alonso Valenzuela Pérez

    Recruiting

  • Hospital General de Occidente

    Guadalajara, 45170

    Ana Turrado

    Not yet recruiting

  • Health Pharma Querétaro

    Juriquilla, 76230

    Amador Garcia

    Not yet recruiting

  • Medical Care and Research SA de CV

    Mérida, 97070

    AXEL MENA QUINTERO

    Recruiting

  • Centro de Investigación Clinica Chapultepec

    Mexico City, 04100

    Elda Rodriguez Negrete

    Recruiting

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

    JESUS YAMAMOTO-FURUSHO

    Not yet recruiting

  • Servicios de Oncología Médica Integral - Monterrey

    Monterrey, 66220

    Manuel Martinez Vazquez

    Recruiting

  • Centro de Investigacion Clinica Chapultepec

    Morelia, 58260

    4431478545

    Araceli Muñoz Bautista

    Recruiting

  • Boca Clinical Trials Mexico SC

    Puebla City, 72160

    2229736952

    Elias Ballesteros Suarez

    Recruiting

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055

    52 55 53627780

    Leticia Marin

    Recruiting

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900

    2299327808

    Aracely Cruz Palacios

    Not yet recruiting

Other trials in Mexico

Brazil15 sites, 15 recruiting

  • NewData Clinical Research - Aracaju

    Aracaju, 49075-000

    +55 79 98825-9395

    Alex Callado França

    Recruiting

  • L2IP - Instituto de Pesquisas Clínicas

    Brasília, 70200730

    6134454300

    Luciana Teixeira de Campos

    Recruiting

  • Loema Instituto de Pesquisa Clinica

    Campinas, 13092-133

    19 3252-5611

    Joaquim Simoes Neto

    Recruiting

  • Fundação Universidade de Caxias do Sul (FUCS)

    Caxias do Sul, 95070-560

    Eduardo Brambilla

    Recruiting

  • Centro Digestivo de Curitiba

    Curitiba, 80430-180

    +55 41 3322-1115

    Odery Ramos Júnior

    Recruiting

  • Galileo Medical Research

    Juiz de Fora, 36033-318

    Julio Chebli

    Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

    +5551999199815

    Luciana Harlacher

    Recruiting

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, 14051-140

    1636022283

    Rogerio Parra

    Recruiting

  • CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição

    Salvador, 41500-300

    55 71 99957 2121

    Genoile Silva

    Recruiting

  • Pesquisare Saude

    Santo André, 09080-110

    ALEXANDER DE SA ROLIM

    Recruiting

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

    +55 11 2776-6801

    Alexandre de Sousa Carlos

    Recruiting

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

    Renata Lamanna

    Recruiting

  • Clínica Hepatogastro JK

    São Paulo, 04543-011

    5511999158070

    Rodrigo Andrey Rocco

    Recruiting

  • CEDOES

    Vitória, 29055450

    5527988393435

    Felipe Ferreira

    Recruiting

  • Integral Pesquisa e Ensino

    Votuporanga, 15500-269

    +5517997472217

    HERLON VALÉRIO

    Recruiting

Other trials in Brazil

Poland12 sites, 12 recruiting

  • Medrise Sp. z o.o.

    Lublin, 20-582

    +48 795 404 502

    Wit Danilkiewicz

    Recruiting

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, 45-819

    690548825

    Agata Lukawska

    Recruiting

  • IRMED

    Piotrkow Trybunalski, 97-300

    Katarzyna Ostrowska

    Recruiting

  • Twoja Przychodnia PCM

    Poznan, 60-324

    +48 724 444 299

    Ewa Furmanowska-Ladorska

    Recruiting

  • Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej

    Poznan, 60-354

    618547552

    Piotr Eder

    Recruiting

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

    604481752

    Bartosz Korczowski

    Recruiting

  • Twoja Przychodnia SCM

    Szczecin, 71-434

    48 91 433 29 19

    Beata Gawdis-Wojnarska

    Recruiting

  • NZOZ GynCentrum - Oddział Warszawa

    Warsaw, 00-124

    Alina Kurylowicz

    Recruiting

  • Vivamed Sp. z o.o.

    Warsaw, 03-580

    604422988

    Robert Petryka

    Recruiting

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, 04-501

    500111648

    Jaroslaw Kierkus

    Recruiting

  • Melita Medical

    Wroclaw, 53-611

    48660551155

    Jaroslaw Leszczyszyn

    Recruiting

  • ETG Zamość

    Zamość, 22-400

    48606930022

    Katarzyna Wojcik

    Recruiting

Other trials in Poland

France10 sites, 10 recruiting

  • Clinique des Cèdres

    Échirolles, 38130

    Nicolas MATHIEU

    Recruiting

  • CHD Vendee

    La Roche-sur-Yon, 85000

    Astrid De Maissin

    Recruiting

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

    Aurelien Amiot

    Recruiting

  • Chu Saint Eloi

    Montpellier, 34295

    33467330224

    Anne Bozon

    Recruiting

  • Centres Médico Chirurgicaux - Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200

    01 41 43 05 73

    Xavier Treton

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, 06202

    33492039367

    Stephane Schneider

    Recruiting

  • Hôpital Saint Antoine

    Paris, 75571

    Julien Kirchgesner

    Recruiting

  • CHU Charles Nicolle

    Rouen, 76031

    Nicolas RICHARD

    Recruiting

  • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270

    Mathilde Barrau

    Recruiting

  • CHU Rangueil

    Toulouse, 31059

    cyrielle Gilletta

    Recruiting

Other trials in France

Spain10 sites, 10 recruiting

  • Centro Médico Teknon

    Barcelona, 08022

    Miquel Sans Cuffi

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    +34932746258

    Natalia Borruel

    Recruiting

  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide

    Ferrol, 15405

    981 336871

    ANA ECHARRI PIUDO

    Recruiting

  • Hospital de Cabueñes

    Gijón, 33394

    Pilar Varela Trastoy

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28028

    Ignacio Marin Jimenez

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    MARIA DOLORES MARTIN ARRANZ

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

    985107878

    Ruth De Francisco

    Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, 31009

    848422391

    CRISTINA RODRIGUEZ GUTIERREZ

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    0034955008800

    Federico Argüelles-Arias

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    961244055

    Marisa Iborra Colomino

    Recruiting

Other trials in Spain

Italy9 sites, 9 recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138

    0512145312

    Fernando Rizzello

    Recruiting

  • Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"

    Castellana Grotte, 70013

    +39 0804994379

    Mauro Mastronardi

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

    0255032141

    Flavio Caprioli

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Silvio Danese

    Recruiting

  • Azienda Ospedale - Università Padova

    Padova, 35128

    +390498217749

    Edoardo Savarino

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

    Linda Ceccarelli

    Recruiting

  • Ospedale Di Circolo

    Rho, 20017

    02 99430.3264

    Simone Saibeni

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    0630154678

    Franco Scaldaferri

    Recruiting

  • Humanitas

    Rozzano, 20089

    0282243263

    Alessandro Armuzzi

    Recruiting

Other trials in Italy

Turkey (Türkiye)9 sites, 9 recruiting

  • Gazi University Health Research and Application Center Gazi Hospital

    Ankara, 06560

    0 505 319 22 57

    Tarkan Karakan

    Recruiting

  • Uludag Universitesi

    Bursa, 16059

    +90 532 301 22 52

    Murat KIYICI

    Recruiting

  • Eskisehir Osmangazi University

    Eskişehir, 26480

    Tuncer Temel

    Recruiting

  • Mustafa Kemal Universitesi

    Hatay, 31030

    Mehmet Demir

    Recruiting

  • Bezmialem Vakf Üniversitesi

    Istanbul, 34093

    Metin Basaranoglu

    Recruiting

  • Ege Universitesi Hastanesi

    Izmir, 35100

    +90 505 782 38 08

    Nalan Unal

    Recruiting

  • Kocaeli University Medical Faculty Hospital

    İzmit, 41380

    0090 505 877 48 21

    Hasan Yilmaz

    Recruiting

  • Mersin University

    Mersin, 33110

    905326145276

    Engin Altintas

    Recruiting

  • Antalya Egitim ve Arastırma Hastanesi

    Muratpaşa, 07050

    Ayhan Hilmi Cekin

    Recruiting

Other trials in Turkey (Türkiye)

Israel8 sites, 8 recruiting

  • Assuta Ashdod Medical Center

    Ashdod, 7747629

    +9720723398277

    Adi Lahat-Zok

    Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    972-4-7772850

    Roni Weisshof

    Recruiting

  • Edith Wolfson Medical Center

    Holon, 5810001

    97235028500

    Eran Israeli

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    +972 26666916

    Benjamin Koslowsky

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    +97239377241 (5)

    Irit Avni-Biron

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 5262100

    0523894508

    Asaf Levartovsky

    Recruiting

  • Sourasky Medical Center

    Tel Aviv, 6423906

    +97236973011

    Nathaniel Cohen

    Recruiting

  • Yitzhak Shamir Medical Center

    Tsrifin, 7033001

    972-8-934-9793

    EFRAT BROIDE

    Recruiting

Other trials in Israel

Canada7 sites, 7 recruiting

  • Gastroenterology and internal medicine research institute

    Edmonton, T5R 1W2

    7804991192

    Allen Lim

    Recruiting

  • London Health Sciences Centre

    London, N6A 5W9

    519-685-8500

    Terry Ponich

    Recruiting

  • London Digestive Disease Institute

    London, N6K 1M6

    Vipul Jairath

    Recruiting

  • Clinique IMD

    Montreal, H3H 1E8

    514-798-0550

    Waqqas Afif

    Recruiting

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

    Jeffrey McCurdy

    Not yet recruiting

  • Vancouver General Hospital

    Vancouver, V5Z 1M9

    Sundeep Singh

    Recruiting

  • (G.I.R.I.) GI Research Institute Foundation

    Vancouver, V5Z 2K5

    Greg Rosenfeld

    Recruiting

Other trials in Canada

Belgium6 sites, 6 recruiting

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300

    053 72 44 28

    Stijn Vanden Branden

    Recruiting

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels, 1070

    003225555422

    Denis Franchimont

    Recruiting

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, 8500

    +32 56 63 33 00

    Wouter Van Moerkercke

    Recruiting

  • UZ Leuven

    Leuven, 3000

    +3216348856

    João Guedelha Sabino

    Recruiting

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000

    +3243237256

    Edouard Louis

    Recruiting

  • Clinical Chc Montlégia

    Liège, 4000

    +3243554211

    Arnaud Colard

    Recruiting

Other trials in Belgium

Czechia6 sites, 6 recruiting

  • SurGal Clinic

    Brno, 602 00

    Jan Ulbrych

    Recruiting

  • Gastroenterologie

    Hradec Králové, 500 02

    +420607142114

    Milan Siroky

    Recruiting

  • EndoArt

    Ostrava, 710 00

    00420602110107

    Radka Koskova

    Recruiting

  • ResTrial GastroEndo s.r.o

    Prague, 143 00

    Ludek Hrdlicka

    Recruiting

  • ISCARE klinické centrum

    Prague, 19000

    +420 725 505 279

    Milan Lukas

    Recruiting

  • Masarykova Nemocnice V Usti Nad Labem

    Ústí nad Labem, 40113

    420477112450

    Michal Tichy

    Recruiting

Other trials in Czechia

Denmark6 sites, 6 recruiting

  • Aarhus Universitetshospital, Skejby

    Aarhus, 8200

    Anders Dige

    Recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Anja Poulsen

    Recruiting

  • Herlev and Gentofte Hospital

    Copenhagen, 2730

    0045 38681848

    Jacob Bjerrum

    Recruiting

  • Aalborg Universitetshospital, Syd

    Gistrup, 9260

    Henrik Jacobsen

    Recruiting

  • Odense Universitetshospital

    Odense, 5000

    Jens Kjeldsen

    Recruiting

  • Vejle Sygehus

    Vejle, 7100

    Maiken Jørgensen

    Recruiting

Other trials in Denmark

Germany6 sites, 6 recruiting

  • Universitätsklinikum Frankfurt Goethe-Universität

    Frankfurt, 60590

    069630187769

    Irina Blumenstein

    Recruiting

  • Praxiszentrum für Gastroenterologie

    Grevenbroich, 41515

    02181475930

    Axel Naumann

    Recruiting

  • Studiengesellschaft Mitteldeutschland GmbH

    Halle, 06108

    00493452997626

    Lars Fechner

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    05115329427

    Ursula Seidler

    Recruiting

  • Eugastro GmbH

    Leipzig, 04103

    00493414935720

    Ingolf Schiefke

    Recruiting

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

    004933124136202

    Daniel Baumgart

    Recruiting

Other trials in Germany

Romania6 sites, 6 recruiting

  • Spitalul Județean de Urgență Bacău

    Bacau, 600114

    0740182009

    ELENA POPOVICI

    Recruiting

  • Spitalul Clinic Colentina

    Bucharest, 020125

    0213152590

    Bogdan Mateescu

    Recruiting

  • Spitalul Universitar de Urgență București

    Bucharest, 050098

    0722546405

    Lucian Negreanu

    Recruiting

  • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

    Constanța, 900591

    +40744761454

    Eugen Dumitru

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About this study

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

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.

Being tested
Mirikizumab, Tirzepatide, Placebo
Medical subject headings
Crohn Disease, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirikizumabDrug

    Also called LY3074828

    Administered IV

  • MirikizumabDrug

    Also called LY3074828

    Administered SC

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT06937099
Study groupRoleWhat they receive
Mirikizumab + TirzepatideExperimentalMirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Receives: Drug: Mirikizumab; Drug: Tirzepatide
Mirikizumab + PlaceboExperimentalMirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Receives: Drug: Mirikizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction

    Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.

    Measured: Week 52

Secondary outcomes (6)

  1. Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission

    Percentage of participants who simultaneously achieve clinical remission by CDAI and endoscopic remission.

    Measured: Week 24, 52

  2. Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI

    Percentage of participants who achieve maintenance of clinical remission by CDAI.

    Measured: Week 52

  3. Percentage of Participants Who Achieved Maintenance of Endoscopic Remission

    Percentage of participants who achieve maintenance of endoscopic remission.

    Measured: Week 52

  4. Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline

    Percentage of participants who achieve corticosteroid-free clinical remission by CDAI among participants who used corticosteroids at baseline.

    Measured: Week 52

  5. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

    Change from baseline in inflammatory bowel disease questionnaire (IBDQ).

    Measured: Baseline, Week 52

  6. Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight

    Percentage of participants who achieve at least a 10% reduction in body weight.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2025
  2. Study start26 Jun 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06937099
Sponsor's protocol ID
27281
Other IDs
2024-520210-21-00, I6T-MC-AMCE
Acronym
COMMIT-CD
Status last verified
Nov 2026
First submitted
18 Apr 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirikizumab and Tirzepatide in people with Crohn's Disease and Obesity or Overweight, run by Eli Lilly and Company at 183 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, Mexico, Brazil, Poland, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06937099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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