LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
NCT ID: NCT07186101
Last Updated: 2026-01-21
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
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RECRUITING
PHASE2
252 participants
INTERVENTIONAL
2025-11-11
2029-03-31
Brief Summary
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Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY4268989 + Mirikizumab
LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2.
LY4268989
Administered PO
Mirikizumab
Administered IV then SC
Mirikizumab + LY4268989 Placebo
Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.
Mirikizumab
Administered IV then SC
LY4268989 Placebo
Administered PO
Interventions
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LY4268989
Administered PO
Mirikizumab
Administered IV then SC
LY4268989 Placebo
Administered PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have moderately to severely active UC as defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES) ≥2 confirmed by central reader and rectal bleeding (RB) ≥1, with endoscopy performed within 21 days before baseline
* Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization
* Are up-to-date on colorectal cancer surveillance per local society guidelines
* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:
* Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)
NOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)
* Advanced therapy-failed participants: Participants 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 (anti-TNF) antibodies or anti-interleukin antibodies (IL-12/23, or IL-23p19), except for
* mirikizumab.
* Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib
* sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod
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, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic
* Have any adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed
Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply
* Have a current or recent acute, active infection
18 Years
80 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
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Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States
Clinnova Research - Anaheim
Anaheim, California, United States
Om Research LLC
Lancaster, California, United States
Biopharma Informatic, LLC
Los Angeles, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
NeoClinical Research
Hialeah, Florida, United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, United States
Clinical Research of Osceola
Kissimmee, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Alliance Medical Research
Lighthouse PT, Florida, United States
Atlantic Medical Research
Margate, Florida, United States
Digestive and Liver Center of Florida
Orlando, Florida, United States
Center for Gastrointestinal Health - Fairview Heights
Belleville, Illinois, United States
Midtown Gastroenterology and Liver Disease
Des Plaines, Illinois, United States
GI Alliance - Glenview
Glenview, Illinois, United States
Gi Alliance - Gurnee
Gurnee, Illinois, United States
Gastroenterology Health Partners
New Albany, Indiana, United States
Gastroenterology Health Partners
Louisville, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, United States
GI Associates - GIA and Endoscopy Center - Flowood
Flowood, Mississippi, United States
Columbia University Irving Medical Center
New York, New York, United States
Digestive Disease Medicine of Central New York
Utica, New York, United States
Gastroenterology & Hepatology Specialists
Canton, Ohio, United States
Dayton Gastroenterology, LLC
Dayton, Ohio, United States
University Gastroenterology - Providence - West River Street
Providence, Rhode Island, United States
Gastroenterology Associates, P.A. of Greenville
Greenville, South Carolina, United States
Gastro One - Walnut Run Road
Cordova, Tennessee, United States
Texas Digestive Disease Consultants - Cedar Park
Cedar Park, Texas, United States
GI Alliance - Dallas - Gaston Avenue
Dallas, Texas, United States
GI Alliance - Fort Worth
Fort Worth, Texas, United States
GI Alliance - Garland
Garland, Texas, United States
GI Alliance - Lubbock
Lubbock, Texas, United States
Southern Star Research Institute
San Antonio, Texas, United States
Tyler Research Institute
Tyler, Texas, United States
GI Alliance-Webster
Webster, Texas, United States
Care Access - Ogden
Ogden, Utah, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
GI Alliance - Richmond
Richmond, Virginia, United States
Washington Gastroenterology - Bellevue
Bellevue, Washington, United States
Uniklinikum Salzburg
Salzburg, , Austria
Medizinische Universität Wien
Vienna, , Austria
Chronos Pesquisa Clínica
Brasília, , Brazil
CAEP - Synvia Labs
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
NewData Clinical Research - Maceió
Maceió, , Brazil
Hospital Ernesto Dornelles
Porto Alegre, , Brazil
Centro Internacional de Pesquisa Clínica (CIPES)
São José dos Campos, , Brazil
CPQuali Pesquisa Clínica
São Paulo, , Brazil
Solare Trials
São Paulo, , Brazil
Hospital Santa Catarina - Paulista
São Paulo, , Brazil
Clínica Hepatogastro JK
São Paulo, , Brazil
Universidade Federal Do Piaui - Campos Universitario
Teresina, , Brazil
Charlton Digestive Disease Centre
Hamilton, , Canada
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London, , Canada
London Digestive Disease Institute
London, , Canada
West GTA Research Inc.
Mississauga, , Canada
C.I.C. Mauricie inc.
Trois-Rivières, , Canada
Changzhou Second People's Hospital
Changzhou, , China
Chongqing General Hospital
Chongqing, , China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, , China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, , China
First Affiliated Hospital of Kunming Medical University
Kunming, , China
Jiangsu Province Hospital
Nanjing, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Shengjing Hospital of China Medical University
Shenyang, , China
The Second Afilliated Hospital of Hebei Medical University
Shijiazhuang, , China
Taian City Central Hospital
Taian, , China
Wuhan Union Hospital
Wuhan, , China
Wuxi People's Hospital
Wuxi, , China
Aalborg Universitetshospital, Syd
Aalborg, , Denmark
Aarhus Universitetshospital, Skejby
Aarhus, , Denmark
Herlev and Gentofte Hospital
Copenhagen, , Denmark
Odense Universitetshospital
Odense, , Denmark
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, , Germany
Studienzentrum MVZ Dachau
Dachau, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
Békéscsaba, , Hungary
Óbudai Egészségügyi Centrum
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Pannónia Magánorvosi Centrum
Budapest, , Hungary
Clinexpert Gyöngyös
Gyöngyös, , Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, , Hungary
Jávorszky Ödön Kórház
Vác, , Hungary
Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
Ahmedabad, , India
Rajiv Gandhi Government General Hospital
Chennai, , India
Ashwin Hospital
Coimbatore, , India
Sushruta Multispeciality Hospital & Research Centre
Hubli, , India
Mahavir Hospital & Research Centre - Hyderabad
Hyderabad, , India
All India Institute of Medical Sciences
New Delhi, , India
Medipoint Hospitals Pvt. Ltd.
Pune, , India
Shree Giriraj Multispeciality Hospital
Rajkot, , India
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Humanitas
Rozzano, , Italy
Fukuoka University Hospital
Fukuoka, , Japan
Gokeikai Ofuna Chuo Hospital
Kamakura, , Japan
Tsujinaka Hospital - Kashiwanoha
Kashiwa, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Toho University Sakura Medical Center
Sakura, , Japan
Sapporo Tokushukai Hospital
Sapporo, , Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, , Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, , Mexico
Boca Clinical Trials Mexico S.C.
Guadajalara, , Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, , Mexico
Centro de Investigación y Gastroenterología - S.C.
Mexico City, , Mexico
Centro de Investigación Clinica Chapultepec
Mexico City, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, , Mexico
Servicios de Oncología Médica Integral - Monterrey
San Pedro Garza García, , Mexico
Scientia Investigacion Clinica S.C.
Tijuana, , Mexico
Clinical Research Institute S.C.
Tlalnepantla, , Mexico
Medimanage Research
Tlalpan, , Mexico
FAICIC S. de R.L. de C.V.
Veracruz, , Mexico
Radboudumc
Nijmegen, , Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, , Netherlands
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, , Poland
IRMED
Piotrkow Trybunalski, , Poland
Pratia Poznań
Poznan, , Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan, , Poland
Twoja Przychodnia SCM
Szczecin, , Poland
Sonomed Sp. z o. o.
Szczecin, , Poland
WSD MEDI
Warsaw, , Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, , Poland
ETG Zamość
Zamość, , Poland
Spitalul de Oncologie Monza
Bucharest, , Romania
Delta Health Care
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, , Romania
Spital Judetean de Urgenta
Satu Mare, , Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, , Romania
Centro Médico Teknon
Barcelona, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, , Spain
Hospital de Cabueñes
Gijón, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Adana City Hospital
Adana, , Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi Hospital
Ankara, , Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, , Turkey (Türkiye)
Eskisehir Osmangazi University
Eskişehir, , Turkey (Türkiye)
Mustafa Kemal Universitesi
Hatay, , Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
İzmit, , Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Malatya, , Turkey (Türkiye)
Mersin University
Mersin, , Turkey (Türkiye)
Dicle Üniversitesi
Sur, , Turkey (Türkiye)
Countries
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Central Contacts
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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
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Related Links
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LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: (TOPAZ-UC)
Other Identifiers
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J6E-MC-KWAN
Identifier Type: OTHER
Identifier Source: secondary_id
MORF-057
Identifier Type: OTHER
Identifier Source: secondary_id
27704
Identifier Type: -
Identifier Source: org_study_id
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