Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
NCT ID: NCT06937086
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
350 participants
INTERVENTIONAL
2025-06-26
2028-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participation in this study will last up to 61 weeks, including 52 weeks of treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
NCT06937099
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
NCT07186101
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
NCT06598943
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
NCT03926130
Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis
NCT07059130
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mirikizumab + Tirzepatide
Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Mirikizumab
Administered IV
Mirikizumab
Administered SC
Tirzepatide
Administered SC
Mirikizumab + Placebo
Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Mirikizumab
Administered IV
Mirikizumab
Administered SC
Placebo
Administered SC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mirikizumab
Administered IV
Mirikizumab
Administered SC
Tirzepatide
Administered SC
Placebo
Administered SC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.
* Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
* Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\]
* Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:
* hypertension
* Type 2 Diabetes Mellitus (T2DM)
* dyslipidemia
* obstructive sleep apnea, or
* cardiovascular disease.
* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab.
Exclusion Criteria
* Crohn's disease
* inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or
* primary sclerosing cholangitis.
* Have had or will need bowel resection or intestinal or intra-abdominal surgery.
* Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.
* 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 a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.
* Have a current or recent acute, active infection.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Icahn School of Medicine at Mount Sinai
New York, New York, 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 - West River Street
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
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, 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
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
Sofia, , Bulgaria
Medical Center Convex
Sofia, , Bulgaria
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London, , Canada
London Digestive Disease Institute
London, , Canada
Clinique IMD
Montreal, , 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
Aalborg Universitetshospital, Syd
Aalborg, , Denmark
Aarhus Universitetshospital, Skejby
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev and Gentofte Hospital
Copenhagen, , 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
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez, , France
CHU Rangueil
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, , Germany
Praxiszentrum für Gastroenterologie
Grevenbroich, , Germany
Studiengesellschaft BSF Unternehmergesellschaft
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
University Hospital of Ioannina
Ioannina, , 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
Padua, , Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
Palermo, , 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
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, , 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
Caribbean Medical Research Center
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
Zemun Medical Centre
Zemun, , Serbia
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 Galdakao-Usansolo
Galdakao, , 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)
Antalya Egitim ve Arastırma Hastanesi
Antalya, , 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)
Southmead Hospital
Bristol, , United Kingdom
Ninewells Hospital and Medical School
Dundee, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
Royal London Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-520209-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
I6T-MC-AMCD
Identifier Type: OTHER
Identifier Source: secondary_id
27280
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.