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RECRUITING Phase 2 ClinicalTrials.gov

LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07186101

Registry updated: 2026-10-08
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Description

The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

Interventions

  • LY4268989 (Drug)
    Administered PO
  • Mirikizumab (Drug)
    Administered IV then SC
  • LY4268989 Placebo (Drug)
    Administered PO

Eligibility criteria

Inclusion Criteria: * Have had an established diagnosis of UC of ≥3 months in 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 mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1. * 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: * 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, 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

Conditions

Ulcerative Colitis

Locations

  • 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
  • Northwestern University — Chicago, 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
  • Digestive Disease Medicine of Central New York — Utica, New York, 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
  • Carilion Clinic — Roanoke, Virginia, United States
  • Washington Gastroenterology - Bellevue — Bellevue, Washington, United States
  • 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
  • BRA - Clínica Médica e Terapia Assistida — Tajaí, Brazil
  • Universidade Federal Do Piaui - Campos Universitario — Teresina, Brazil
  • Charlton Digestive Disease Centre — Hamilton, Canada
  • 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
  • Herlev and Gentofte Hospital — Copenhagen, Denmark
  • Aalborg Universitetshospital, Syd — Gistrup, Denmark
  • Odense Universitetshospital — Odense, Denmark
  • Charité Universitaetsmedizin Berlin - Campus Mitte — Berlin, Germany
  • Studienzentrum MVZ Dachau — Dachau, Germany
  • Universitaetsklinikum Erlangen — Erlangen, 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
  • 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
  • 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)
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Official Source

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

View Official Record