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

NCT06937099 · Eli Lilly and Company
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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
About this study
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.
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.
Study design
Enrollment target: 290 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-06-26
Estimated completion: 2028-05
Last updated: 2026-04-17
Interventions
Drug: MirikizumabDrug: MirikizumabDrug: TirzepatideDrug: Placebo
Primary outcomes
  • Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction (Week 52)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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) · study_director, Eli Lilly and Company
All locations (187)
Digestive Health SpecialistsRecruiting
Dothan, Alabama, United States
Smart Cures Clinical ResearchRecruiting
Anaheim, California, United States
Cedars-Sinai Medical CenterNot Yet Recruiting
Beverly Hills, California, United States
United Medical Doctors - Los AlamitosRecruiting
Los Alamitos, California, United States
California Medical Research AssociatesRecruiting
Northridge, California, United States
Research Associates of South Florida - Miami - Southwest 8th StreetRecruiting
Miami, Florida, United States
Gastro Health Research - MiamiRecruiting
Miami, Florida, United States
Orlando HealthRecruiting
Orlando, Florida, United States
Digestive and Liver Center of FloridaRecruiting
Orlando, Florida, United States
Gastro Health Research - PensacolaRecruiting
Pensacola, Florida, United States
Precision Clinical ResearchRecruiting
Sunrise, Florida, United States
Grand Teton Research GroupRecruiting
Idaho Falls, Idaho, United States
Rush University Medical CenterNot Yet Recruiting
Chicago, Illinois, United States
Indiana University Health University HospitalRecruiting
Indianapolis, Indiana, United States
Gastroenterology Health PartnersRecruiting
New Albany, Indiana, United States
Gastroenterology Health PartnersRecruiting
Louisville, Kentucky, United States
Care Access - New IberiaRecruiting
New Iberia, Louisiana, United States
Louisiana Research CenterRecruiting
Shreveport, Louisiana, United States
Capital Digestive Care - Chevy ChaseRecruiting
Chevy Chase, Maryland, United States
Lucida Clinical TrialsRecruiting
New Bedford, Massachusetts, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
New York Gastroenterology AssociatesRecruiting
New York, New York, United States
Care Access - YonkersRecruiting
Yonkers, New York, United States
Coastal Research Institute - FayettevilleRecruiting
Fayetteville, North Carolina, United States
Gastro Intestinal Research Institute of Northern Ohio, LLCRecruiting
Westlake, Ohio, United States
Thomas Jefferson University - Medicine/GI and HepatologyRecruiting
Philadelphia, Pennsylvania, United States
University Gastroenterology - Providence - West River StreetRecruiting
Providence, Rhode Island, United States
Gastroenterology Associates - PatewoodRecruiting
Greenville, South Carolina, United States
Gastroenterology Center Of The MidsouthRecruiting
Cordova, Tennessee, United States
Gastroenterology Research of San AntonioRecruiting
San Antonio, Texas, United States
Southern Star Research InstituteRecruiting
San Antonio, Texas, United States
Tyler Research InstituteRecruiting
Tyler, Texas, United States
Washington Gastroenterology - TacomaRecruiting
Tacoma, Washington, United States
Wisconsin Center for Advanced ResearchRecruiting
Milwaukee, Wisconsin, United States
Medizinische Universität GrazRecruiting
Graz, Austria
Medizinische Universitaet InnsbruckNot Yet Recruiting
Innsbruck, Austria
Medizinische Universität WienRecruiting
Vienna, Austria
AZORG Campus Aalst-MoorselbaanRecruiting
Aalst, Belgium
Université Libre de Bruxelles - Hôpital ErasmeRecruiting
Brussels, Belgium
AZ Groeninge Campus KennedylaanRecruiting
Kortrijk, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart TilmanRecruiting
Liège, Belgium
Clinical Chc MontlégiaRecruiting
Liège, Belgium
NewData Clinical Research - AracajuRecruiting
Aracaju, Brazil
L2IP - Instituto de Pesquisas ClínicasNot Yet Recruiting
Brasília, Brazil
Loema Instituto de Pesquisa ClinicaRecruiting
Campinas, Brazil
Fundação Universidade de Caxias do Sul (FUCS)Recruiting
Caxias do Sul, Brazil
Centro Digestivo de CuritibaRecruiting
Curitiba, Brazil
Galileo Medical ResearchRecruiting
Juiz de Fora, Brazil
Hospital de Clinicas de Porto AlegreRecruiting
Porto Alegre, Brazil
Hospital de Clínicas de Ribeirão PretoRecruiting
Ribeirão Preto, Brazil
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e NutriçãoRecruiting
Salvador, Brazil
Pesquisare SaudeRecruiting
Santo André, Brazil
CPQuali Pesquisa ClínicaRecruiting
São Paulo, Brazil
CEPIC - Centro Paulista de Investigação ClínicaRecruiting
São Paulo, Brazil
Clínica Hepatogastro JKRecruiting
São Paulo, Brazil
CEDOESRecruiting
Vitória, Brazil
Integral Pesquisa e EnsinoRecruiting
Votuporanga, Brazil
University Hospital "St. Ivan Rilski"Recruiting
Gorna Oryahovitsa, Bulgaria
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EADNot Yet Recruiting
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EADNot Yet Recruiting
Sofia, Bulgaria
Gastroenterology and internal medicine research instituteNot Yet Recruiting
Edmonton, Canada
Victoria Hospital & Children's Hospital - London Health Sciences CentreRecruiting
London, Canada
London Digestive Disease InstituteRecruiting
London, Canada
Clinique IMDRecruiting
Montreal, Canada
The Ottawa Hospital - General CampusNot Yet Recruiting
Ottawa, Canada
Vancouver General HospitalNot Yet Recruiting
Vancouver, Canada
(G.I.R.I.) GI Research Institute FoundationNot Yet Recruiting
Vancouver, Canada
SurGal ClinicRecruiting
Brno, Czechia
GastroenterologieRecruiting
Hradec Králové, Czechia
EndoArtRecruiting
Ostrava, Czechia
ResTrial GastroEndo s.r.oRecruiting
Prague, Czechia
ISCARE klinické centrumRecruiting
Prague, Czechia
Masarykova Nemocnice V Usti Nad LabemRecruiting
Ústí nad Labem, Czechia
Aarhus Universitetshospital, SkejbyRecruiting
Aarhus, Denmark
RigshospitaletRecruiting
Copenhagen, Denmark
Herlev and Gentofte HospitalRecruiting
Copenhagen, Denmark
Aalborg Universitetshospital, SydRecruiting
Gistrup, Denmark
Odense UniversitetshospitalNot Yet Recruiting
Odense, Denmark
Vejle SygehusRecruiting
Vejle, Denmark
Clinique des CèdresRecruiting
Échirolles, France
CHD VendeeRecruiting
La Roche-sur-Yon, France
Hôpitaux Universitaires Paris Sud - Hôpital BicêtreRecruiting
Le Kremlin-Bicêtre, France
Chu Saint EloiRecruiting
Montpellier, France
Centres Médico Chirurgicaux - Clinique Ambroise ParéRecruiting
Neuilly-sur-Seine, France
Centre Hospitalier Universitaire de Nice - Hôpital l'ArchetRecruiting
Nice, France
Hôpital Saint AntoineRecruiting
Paris, France
CHU Charles NicolleRecruiting
Rouen, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital NordRecruiting
Saint-Priest-en-Jarez, France
CHU RangueilRecruiting
Toulouse, France
Clinique PasteurNot Yet Recruiting
Toulouse, France
Universitätsklinikum Frankfurt Goethe-UniversitätRecruiting
Frankfurt, Germany
Praxiszentrum für GastroenterologieRecruiting
Grevenbroich, Germany
Studiengesellschaft BSF UnternehmergesellschaftRecruiting
Halle, Germany
Medizinische Hochschule HannoverRecruiting
Hanover, Germany
Eugastro GmbHRecruiting
Leipzig, Germany
Klinikum Ernst von BergmannRecruiting
Potsdam, Germany
Evangelismos General Hospital of AthensRecruiting
Athens, Greece
Thoracic General Hospital of Athens "I Sotiria"Recruiting
Athens, Greece
University General Hospital of HeraklionRecruiting
Heraklion, Greece
Ippokrateio General Hospital of ThessalonikiRecruiting
Thessaloniki, Greece
Semmelweis EgyetemRecruiting
Budapest, Hungary
Semmelweis EgyetemRecruiting
Budapest, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai KözpontRecruiting
Szeged, Hungary
CLINFAN Szolgáltató KftRecruiting
Szekszárd, Hungary
Assuta Ashdod Medical CenterRecruiting
Ashdod, Israel
Rambam Health Care CampusRecruiting
Haifa, Israel
Edith Wolfson Medical CenterRecruiting
Holon, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Yitzhak Shamir Medical CenterRecruiting
Ẕerifin, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'OrsolaRecruiting
Bologna, Italy
Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"Recruiting
Castellana Grotte, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting
Milan, Italy
Ospedale San RaffaeleNot Yet Recruiting
Milan, Italy
Azienda Ospedale - Università PadovaRecruiting
Padova, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLONot Yet Recruiting
Palermo, Italy
Azienda Ospedaliero Universitaria PisanaRecruiting
Pisa, Italy
Ospedale Di CircoloRecruiting
Rho, Italy
Fondazione Policlinico Universitario Agostino GemelliRecruiting
Roma, Italy
HumanitasRecruiting
Rozzano, Italy
San Peregrino Unidad de InvestigaciónNot Yet Recruiting
Aguascalientes, Mexico
Scientia Investigacion Clinica S.C.Recruiting
Chihuahua City, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.Recruiting
Ciudad Madero, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.Not Yet Recruiting
Durango, Mexico
Boca Clinical Trials Mexico S.C.Recruiting
Guadajalara, Mexico
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)Not Yet Recruiting
Guadalajara, Mexico
Hospital General de OccidenteNot Yet Recruiting
Guadalajara, Mexico
Health Pharma QuerétaroNot Yet Recruiting
Juriquilla, Mexico
Centro de Investigación Clinica ChapultepecNot Yet Recruiting
Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNot Yet Recruiting
Mexico City, Mexico
Medical Care and Research SA de CVRecruiting
Mérida, Mexico
Servicios de Oncología Médica Integral - MonterreyRecruiting
Monterrey, Mexico
Centro de Investigacion Clinica ChapultepecNot Yet Recruiting
Morelia, Mexico
Boca Clinical Trials Mexico SCNot Yet Recruiting
Puebla City, Mexico
Clinical Research Institute S.C.Not Yet Recruiting
Tlalnepantla, Mexico
FAICIC S. de R.L. de C.V.Not Yet Recruiting
Veracruz, Mexico
Amsterdam UMC, locatie VUmcRecruiting
Amsterdam, Netherlands
RadboudumcNot Yet Recruiting
Nijmegen, Netherlands
Erasmus Medisch CentrumNot Yet Recruiting
Rotterdam, Netherlands
Ikazia ZiekenhuisRecruiting
Rotterdam, Netherlands
Universitair Medisch Centrum UtrechtRecruiting
Utrecht, Netherlands
Medrise Sp. z o.o.Recruiting
Lublin, Poland
Twoja Przychodnia Opolskie Centrum MedyczneRecruiting
Opole, Poland
IRMEDRecruiting
Piotrkow Trybunalski, Poland
Twoja Przychodnia PCMRecruiting
Poznan, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny SpecjalistycznejNot Yet Recruiting
Poznan, Poland
Korczowski Bartosz, Gabinet LekarskiRecruiting
Rzeszów, Poland
Twoja Przychodnia SCMRecruiting
Szczecin, Poland
NZOZ GynCentrum - Oddział WarszawaRecruiting
Warsaw, Poland
Vivamed Sp. z o.o.Recruiting
Warsaw, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor KierkuśRecruiting
Warsaw, Poland
Melita MedicalRecruiting
Wroclaw, Poland
ETG ZamośćRecruiting
Zamość, Poland
CMRC Headlands, LLCRecruiting
San Juan, Puerto Rico
Spitalul Județean de Urgență BacăuRecruiting
Bacau, Romania
Spitalul Clinic ColentinaRecruiting
Bucharest, Romania
Spitalul Universitar de Urgență BucureștiRecruiting
Bucharest, Romania
Constanta County Emergency Clinical Hospital Sf.Ap.AndreiRecruiting
Constanța, Romania
Spitalul Clinic Județean de UrgențăRecruiting
Craiova, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.LRecruiting
Timișoara, Romania
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska BystricaRecruiting
Banská Bystrica, Slovakia
Cliniq s.r.o.Recruiting
Bratislava, Slovakia
ENDOMEDRecruiting
Košice, Slovakia
Gastro LMRecruiting
Prešov, Slovakia
Centro Médico TeknonRecruiting
Barcelona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto MarcideNot Yet Recruiting
Ferrol, Spain
Hospital de CabueñesRecruiting
Gijón, Spain
Hospital General Universitario Gregorio MarañonNot Yet Recruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario Central de AsturiasRecruiting
Oviedo, Spain
Complejo Hospitalario de NavarraRecruiting
Pamplona, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
Gazi University Health Research and Application Center Gazi HospitalRecruiting
Ankara, Turkey (Türkiye)
Uludag UniversitesiRecruiting
Bursa, Turkey (Türkiye)
Eskisehir Osmangazi UniversityRecruiting
Eskişehir, Turkey (Türkiye)
Mustafa Kemal UniversitesiNot Yet Recruiting
Hatay, Turkey (Türkiye)
Bezmialem Vakf ÜniversitesiRecruiting
Istanbul, Turkey (Türkiye)
Ege Universitesi HastanesiNot Yet Recruiting
Izmir, Turkey (Türkiye)
Kocaeli University Medical Faculty HospitalRecruiting
İzmit, Turkey (Türkiye)
Mersin UniversityRecruiting
Mersin, Turkey (Türkiye)
Antalya Egitim ve Arastırma HastanesiNot Yet Recruiting
Muratpaşa, Turkey (Türkiye)
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight · TrialPath