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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT06937099

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Mirikizumab (Drug)
    Administered IV
  • Mirikizumab (Drug)
    Administered SC
  • Tirzepatide (Drug)
    Administered SC
  • Placebo (Drug)
    Administered SC

Eligibility criteria

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.

Conditions

Crohn's Disease Obesity or Overweight

Locations

  • 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
  • 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 — Padova, 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
  • CMRC Headlands, LLC — 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 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)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record