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
COMMIT-UC
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 Ulcerative Colitis and Obesity or Overweight
3 other identifiers
interventional
350
23 countries
191
Brief Summary
The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2025
Typical duration for phase_3
191 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedStudy Start
First participant enrolled
June 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
April 17, 2026
April 1, 2026
2.8 years
April 18, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction
Percentage of participants who simultaneously achieve clinical remission and at least 10% weight reduction.
Week 52
Secondary Outcomes (7)
Percentage of Participants Who Achieve Clinical Remission
Week 24 and Week 52
Percentage of Participants Who Achieve Endoscopic Response
Week 24 and Week 52
Percentage of Participants Who Achieve Histologic-Endoscopic Mucosal Improvement Plus Absence of Neutrophils
Week 24 and Week 52
Percentage of Participants Who Achieve Clinical Response
Week 24 and Week 52
Percentage of Participants Who Achieve Endoscopic Remission
Week 24 and Week 52
- +2 more secondary outcomes
Study Arms (2)
Mirikizumab + Tirzepatide
EXPERIMENTALMirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Mirikizumab + Placebo
EXPERIMENTALMirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Interventions
Administered IV
Eligibility Criteria
You may qualify if:
- Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.
- 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.
You may not qualify if:
- Have a current diagnosis of:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (191)
Digestive Health Specialists
Dothan, Alabama, 36301, United States
Smart Cures Clinical Research
Anaheim, California, 92806, United States
Cedars-Sinai Medical Center
Beverly Hills, California, 90211, United States
United Medical Doctors - Los Alamitos
Los Alamitos, California, 90720, United States
California Medical Research Associates
Northridge, California, 91324, United States
Research Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida, 33134, United States
Gastro Health Research - Miami
Miami, Florida, 33176, United States
Orlando Health
Orlando, Florida, 32806, United States
Digestive and Liver Center of Florida
Orlando, Florida, 32825, United States
Gastro Health Research - Pensacola
Pensacola, Florida, 32504, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
Gastroenterology Health Partners
New Albany, Indiana, 47150, United States
Gastroenterology Health Partners
Louisville, Kentucky, 40218, United States
Care Access - New Iberia
New Iberia, Louisiana, 70560, United States
Louisiana Research Center
Shreveport, Louisiana, 71105, United States
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, 20815, United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
New York Gastroenterology Associates
New York, New York, 10075, United States
Care Access - Yonkers
Yonkers, New York, 10701, United States
Coastal Research Institute - Fayetteville
Fayetteville, North Carolina, 28304, United States
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, 44145, United States
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania, 19107, United States
University Gastroenterology - Providence - West River Street
Providence, Rhode Island, 02904, United States
Gastroenterology Associates - Patewood
Greenville, South Carolina, 29607, United States
Gastroenterology Center Of The Midsouth
Cordova, Tennessee, 38018, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229, United States
Southern Star Research Institute
San Antonio, Texas, 78229, United States
Tyler Research Institute
Tyler, Texas, 75701, United States
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, 24014, United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, 98405, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
AZORG Campus Aalst-Moorselbaan
Aalst, 9300, Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, 1070, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Clinical Chc Montlégia
Liège, 4000, Belgium
NewData Clinical Research - Aracaju
Aracaju, 49075-000, Brazil
L2IP - Instituto de Pesquisas Clínicas
Brasília, 70200730, Brazil
Loema Instituto de Pesquisa Clinica
Campinas, 13092-133, Brazil
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, 95070-560, Brazil
Centro Digestivo de Curitiba
Curitiba, 80430-180, Brazil
Galileo Medical Research
Juiz de Fora, 36033-318, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, 14051-140, Brazil
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador, 41500-300, Brazil
Pesquisare Saude
Santo André, 09080-110, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
Clínica Hepatogastro JK
São Paulo, 04543-011, Brazil
CEDOES
Vitória, 29055450, Brazil
Integral Pesquisa e Ensino
Votuporanga, 15500-269, Brazil
University Hospital "St. Ivan Rilski"
Gorna Oryahovitsa, 5100, Bulgaria
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
Sofia, 1233, Bulgaria
Medical Center Convex
Sofia, 1680, Bulgaria
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London, N6A 5W9, Canada
London Digestive Disease Institute
London, N6K 1M6, Canada
Clinique IMD
Montreal, H3H 1E8, Canada
The Ottawa Hospital - General Campus
Ottawa, K1H 8L6, Canada
Vancouver General Hospital
Vancouver, V5Z 1M9, Canada
(G.I.R.I.) GI Research Institute Foundation
Vancouver, V5Z 2K5, Canada
SurGal Clinic
Brno, 602 00, Czechia
Gastroenterologie
Hradec Králové, 500 02, Czechia
EndoArt
Ostrava, 710 00, Czechia
ResTrial GastroEndo s.r.o
Prague, 143 00, Czechia
ISCARE klinické centrum
Prague, 19000, Czechia
Masarykova Nemocnice V Usti Nad Labem
Ústí nad Labem, 40113, Czechia
Aarhus Universitetshospital, Skejby
Aarhus, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Herlev and Gentofte Hospital
Copenhagen, 2730, Denmark
Aalborg Universitetshospital, Syd
Gistrup, 9260, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Clinique des Cèdres
Échirolles, 38130, France
CHD Vendee
La Roche-sur-Yon, 85000, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Chu Saint Eloi
Montpellier, 34295, France
Centres Médico Chirurgicaux - Clinique Ambroise Paré
Neuilly-sur-Seine, 92200, France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, 06202, France
Hôpital Saint Antoine
Paris, 75571, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
CHU Rangueil
Toulouse, 31059, France
Clinique Pasteur
Toulouse, 31076, France
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, 60590, Germany
Praxiszentrum für Gastroenterologie
Grevenbroich, 41515, Germany
Studiengesellschaft BSF Unternehmergesellschaft
Halle, 06108, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Eugastro GmbH
Leipzig, 04103, Germany
Klinikum Ernst von Bergmann
Potsdam, 14467, Germany
Evangelismos General Hospital of Athens
Athens, 106 76, Greece
Thoracic General Hospital of Athens "I Sotiria"
Athens, 115 27, Greece
University General Hospital of Heraklion
Heraklion, 711 10, Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, 54642, Greece
Semmelweis Egyetem
Budapest, 1082, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6725, Hungary
CLINFAN Szolgáltató Kft
Szekszárd, 7100, Hungary
Assuta Ashdod Medical Center
Ashdod, 7747629, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Edith Wolfson Medical Center
Holon, 5810001, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Sourasky Medical Center
Tel Aviv, 6423906, Israel
Yitzhak Shamir Medical Center
Ẕerifin, 7033001, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
Castellana Grotte, 70013, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedale - Università Padova
Padova, 35128, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
Palermo, 90146, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
Ospedale Di Circolo
Rho, 20017, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Humanitas
Rozzano, 20089, Italy
San Peregrino Unidad de Investigación
Aguascalientes, 20230, Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, 89440, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Boca Clinical Trials Mexico S.C.
Guadajalara, 44600, Mexico
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara, 44340, Mexico
Hospital General de Occidente
Guadalajara, 45170, Mexico
Health Pharma Querétaro
Juriquilla, 76230, Mexico
Centro de Investigación Clinica Chapultepec
Mexico City, 04100, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
Medical Care and Research SA de CV
Mérida, 97070, Mexico
Servicios de Oncología Médica Integral - Monterrey
Monterrey, 66220, Mexico
Centro de Investigacion Clinica Chapultepec
Morelia, 58260, Mexico
Boca Clinical Trials Mexico SC
Puebla City, 72160, Mexico
Clinical Research Institute S.C.
Tlalnepantla, 54055, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900, Mexico
Amsterdam UMC, locatie VUmc
Amsterdam, 1081 HZ, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Ikazia Ziekenhuis
Rotterdam, 3083 AN, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45-819, Poland
IRMED
Piotrkow Trybunalski, 97-300, Poland
Twoja Przychodnia PCM
Poznan, 60-324, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan, 60-354, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Twoja Przychodnia SCM
Szczecin, 71-434, Poland
NZOZ GynCentrum - Oddział Warszawa
Warsaw, 00-124, Poland
Vivamed Sp. z o.o.
Warsaw, 03-580, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, 04-501, Poland
Melita Medical
Wroclaw, 53-611, Poland
ETG Zamość
Zamość, 22-400, Poland
CMRC Headlands, LLC
San Juan, 00918, Puerto Rico
Spitalul Județean de Urgență Bacău
Bacau, 600114, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Spitalul Universitar de Urgență București
Bucharest, 050098, Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, 900591, Romania
Spitalul Clinic Județean de Urgență
Craiova, 200642, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, 300002, Romania
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, 97517, Slovakia
Cliniq s.r.o.
Bratislava, 81109, Slovakia
ENDOMED
Košice, 040 13, Slovakia
Gastro LM
Prešov, 080 01, Slovakia
Centro Médico Teknon
Barcelona, 08022, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide
Ferrol, 15405, Spain
Hospital de Cabueñes
Gijón, 33394, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28028, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Complejo Hospitalario de Navarra
Pamplona, 31009, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Gazi University Health Research and Application Center Gazi Hospital
Ankara, 06560, Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100, Turkey (Türkiye)
Uludag Universitesi
Bursa, 16059, Turkey (Türkiye)
Eskisehir Osmangazi University
Eskişehir, 26480, Turkey (Türkiye)
Mustafa Kemal Universitesi
Hatay, 31030, Turkey (Türkiye)
Bezmialem Vakf Üniversitesi
Istanbul, 34093, Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
İzmit, 41380, Turkey (Türkiye)
Mersin University
Mersin, 33110, Turkey (Türkiye)
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Ninewells Hospital and Medical School
Dundee, DD1 9SY, United Kingdom
Royal Devon & Exeter Hospital
Exeter, EX2 5DW, United Kingdom
Royal London Hospital
London, E1 2AJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Mirikizumab will be open label, tirzepatide and placebo to match will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2025
First Posted
April 22, 2025
Study Start
June 26, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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.