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

June 3, 2026 updated by: Eli Lilly and Company

A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Not yet recruiting
        • Uniklinikum Salzburg
        • Principal Investigator:
          • Sonja Heeren
        • Contact:
          • Phone Number: 435725557296
      • Vienna, Austria, 1090
        • Not yet recruiting
        • Medizinische Universität Wien
        • Principal Investigator:
          • Walter Reinisch
        • Contact:
          • Phone Number: 004314040062450
  • Brazil
      • Brasília, Brazil, 72145-450
        • Not yet recruiting
        • Chronos Pesquisa Clinica
        • Principal Investigator:
          • Cintia Mendes Clemente
        • Contact:
          • Phone Number: 61999780700
      • Campinas, Brazil, 13087-567
        • Recruiting
        • CAEP - Synvia Labs
        • Principal Investigator:
          • Leandro Negreiros
      • Caxias do Sul, Brazil, 95070-560
        • Recruiting
        • Fundação Universidade de Caxias do Sul (FUCS)
        • Principal Investigator:
          • Eduardo Brambilla
      • Curitiba, Brazil, 80430-180
        • Recruiting
        • Centro Digestivo de Curitiba
        • Contact:
          • Phone Number: +55 41 3322-1115
        • Principal Investigator:
          • Odery Ramos Júnior
      • Juiz de Fora, Brazil, 36033-318
        • Recruiting
        • Galileo Medical Research
        • Principal Investigator:
          • Julio Chebli
      • Maceió, Brazil, 57020-360
        • Recruiting
        • NewData Clinical Research - Maceió
        • Principal Investigator:
          • Alex Callado França
        • Contact:
          • Phone Number: +55 79 98825-9395
      • Porto Alegre, Brazil, 90160-092
        • Not yet recruiting
        • Hospital Ernesto Dornelles
        • Principal Investigator:
          • Cristina Flores
        • Contact:
          • Phone Number: +5551999624012
      • São José dos Campos, Brazil, 12230-001
        • Recruiting
        • Centro Internacional de Pesquisa Clínica (CIPES)
        • Principal Investigator:
          • Anderson Silva
      • São Paulo, Brazil, 01228-000
        • Recruiting
        • CPQuali Pesquisa Clínica
        • Principal Investigator:
          • Alexandre de Sousa Carlos
        • Contact:
          • Phone Number: +55 11 2776-6801
      • São Paulo, Brazil, 04543-011
        • Recruiting
        • Clínica Hepatogastro JK
        • Principal Investigator:
          • Rodrigo Andrey Rocco
        • Contact:
          • Phone Number: 5511999158070
      • São Paulo, Brazil, 01310-000
        • Not yet recruiting
        • Hospital Santa Catarina - Paulista
        • Principal Investigator:
          • ISAAC ALTIKES
      • São Paulo, Brazil, 01307-002
        • Suspended
        • Solare Trials
      • Tajaí, Brazil, 88301-220
        • Not yet recruiting
        • BRA - Clínica Médica e Terapia Assistida
        • Principal Investigator:
          • Munique Kurtz de Mello
      • Teresina, Brazil, 64049-550
        • Recruiting
        • Universidade Federal Do Piaui - Campos Universitario
        • Contact:
          • Phone Number: +55 86 999813603
        • Principal Investigator:
          • José Miguel Parente
  • Canada
      • Hamilton, Canada, L8N 1Y2
        • Recruiting
        • Charlton Digestive Disease Centre
        • Principal Investigator:
          • Neeraj Narula
        • Contact:
          • Phone Number: 905-526-7002 x 3123
      • London, Canada, N6A 5W9
        • Not yet recruiting
        • London Health Sciences Centre
        • Contact:
          • Phone Number: 519-685-8500
        • Principal Investigator:
          • Terry Ponich
      • London, Canada, N6K 1M6
        • Recruiting
        • London Digestive Disease Institute
        • Principal Investigator:
          • Vipul Jairath
      • Mississauga, Canada, L5M 2S4
        • Recruiting
        • West GTA Research Inc.
        • Principal Investigator:
          • Arif Yusuf
      • Trois-Rivières, Canada, G8T 7A1
        • Recruiting
        • C.I.C. Mauricie inc.
        • Principal Investigator:
          • Madeleine Bonneviot
  • China
      • Changzhou, China, 213000
        • Recruiting
        • Changzhou Second People's Hospital
        • Principal Investigator:
          • Wenjia LIU
      • Chongqing, China, 401147
        • Recruiting
        • Chongqing General Hospital
        • Principal Investigator:
          • Hong Guo
        • Contact:
          • Phone Number: 86-13508389768
      • Fuzhou, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Principal Investigator:
          • Chengdang Wang
        • Contact:
          • Phone Number: 86 13178111141
      • Hangzhou, China, 310018
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Qian Cao
      • Kunming, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • Juan Luo
      • Nanjing, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Hongjie ZHANG
      • Qingdao, China, 266003
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Principal Investigator:
          • Xueli Ding
      • Shenyang, China, 110004
        • Recruiting
        • Shengjing Hospital Of China Medical University
        • Principal Investigator:
          • Lixuan Sang
      • Shijiazhuang, China, 050000
        • Recruiting
        • The Second Afilliated Hospital of Hebei Medical University
        • Principal Investigator:
          • Xiaolan Zhang
      • Taian, China, 271000
        • Recruiting
        • Taian City Central Hospital
        • Principal Investigator:
          • Haipeng Yuan
        • Contact:
          • Phone Number: 13375387610
      • Wuhan, China, 430022
        • Recruiting
        • Wuhan Union Hospital
        • Principal Investigator:
          • Rong LIN
      • Wuxi, China, 214023
        • Recruiting
        • Wuxi People's Hospital
        • Principal Investigator:
          • Qunyan Zhou
  • Denmark
      • Copenhagen, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital
        • Principal Investigator:
          • Jakob Seidelin
      • Gistrup, Denmark, 9260
        • Recruiting
        • Aalborg Universitetshospital, Syd
        • Principal Investigator:
          • Jan Fallingborg
        • Contact:
          • Phone Number: +4597663560
      • Odense, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital
        • Principal Investigator:
          • Mark Ainsworth
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte
        • Principal Investigator:
          • Christoph Jochum
        • Contact:
          • Phone Number: 004930450614031
      • Dachau, Germany, 85221
        • Recruiting
        • Studienzentrum MVZ Dachau
        • Principal Investigator:
          • Wilfred Landry
        • Contact:
          • Phone Number: 004981316119311
      • Erlangen, Germany, 91054
        • Not yet recruiting
        • Universitaetsklinikum Erlangen
        • Principal Investigator:
          • Sebastian Zundler
      • Regensburg, Germany, 93053
        • Not yet recruiting
        • Universitätsklinikum Regensburg
        • Contact:
          • Phone Number: +499419447010
        • Principal Investigator:
          • Arne Kandulski
      • Ulm, Germany, 89081
        • Not yet recruiting
        • Universitaetsklinikum Ulm
        • Principal Investigator:
          • Jochen Klaus
        • Contact:
          • Phone Number: 0497315000
  • Hungary
      • Budapest, Hungary, 1036
        • Recruiting
        • Óbudai Egészségügyi Centrum
        • Principal Investigator:
          • Tamás Toth
        • Contact:
          • Phone Number: 06309399575
      • Budapest, Hungary, 1088
        • Recruiting
        • Semmelweis Egyetem
        • Principal Investigator:
          • Zsolt Tulassay
        • Contact:
          • Phone Number: 3612664616
      • Budapest, Hungary, 1136
        • Recruiting
        • Pannónia Magánorvosi Centrum
        • Principal Investigator:
          • Robert Schnabel
        • Contact:
          • Phone Number: 003613301143
      • Békéscsaba, Hungary, 5600
        • Recruiting
        • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
        • Principal Investigator:
          • Marta Varga
        • Contact:
          • Phone Number: 003666555582
      • Gyöngyös, Hungary, 3200
        • Recruiting
        • Clinexpert Gyongyos
        • Principal Investigator:
          • Gyula Horvat
        • Contact:
          • Phone Number: +36209650290
      • Tatabánya, Hungary, 2800
        • Recruiting
        • Komarom-Esztergom Varmegyei Szent Borbala Korhaz
        • Principal Investigator:
          • András Káfony
        • Contact:
          • Phone Number: 36309578269
      • Vác, Hungary, 2600
        • Recruiting
        • Javorszky Odon Korhaz
        • Principal Investigator:
          • Tibor Szaloki
        • Contact:
          • Phone Number: +36302001489
  • India
      • Ahmedabad, India, 380006
        • Not yet recruiting
        • Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
        • Contact:
          • Phone Number: 09825005167
        • Principal Investigator:
          • Kaushal Vyas
      • Chennai, India, 600003
        • Not yet recruiting
        • Rajiv Gandhi Government General Hospital
        • Principal Investigator:
          • Senthil Ponnaiah
      • Coimbatore, India, 641012
        • Not yet recruiting
        • Ashwin Hospital
        • Principal Investigator:
          • Ganesh Muniappan
      • Hubli, India, 580021
        • Not yet recruiting
        • Sushruta Multispeciality Hospital & Research Centre
        • Contact:
          • Phone Number: 09448804251
        • Principal Investigator:
          • LAXMIKANT DESAI
      • Hyderabad, India, 500004
        • Not yet recruiting
        • Mahavir Hospital & Research Centre - Hyderabad
        • Principal Investigator:
          • Sameer Kumar
      • New Delhi, India, 110029
        • Not yet recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Vineet Ahuja
        • Contact:
          • Phone Number: 09867932836
      • Pune, India, 411007
        • Not yet recruiting
        • Medipoint Hospitals Pvt. Ltd.
        • Principal Investigator:
          • Pankaj Nemade
      • Rajkot, India, 360005
        • Not yet recruiting
        • Shree Giriraj Multispeciality Hospital
        • Principal Investigator:
          • Chetan Mehta
  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
        • Principal Investigator:
          • Flavio Caprioli
        • Contact:
          • Phone Number: 0255032141
      • Milan, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele
        • Principal Investigator:
          • Silvio Danese
      • Milan, Italy, 20162
        • Not yet recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Principal Investigator:
          • Marcello Vangeli
      • Roma, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli
        • Principal Investigator:
          • Franco Scaldaferri
        • Contact:
          • Phone Number: 0630154678
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • Humanitas
        • Principal Investigator:
          • Alessandro Armuzzi
        • Contact:
          • Phone Number: 0282243263
  • Japan
      • Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital
        • Principal Investigator:
          • Fumihito Hirai
        • Contact:
          • Phone Number: 81120023812
      • Kamakura, Japan, 247-0056
        • Recruiting
        • Gokeikai Ofuna Chuo Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Atsushi Yoshida
      • Kashiwa, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital - Kashiwanoha
        • Principal Investigator:
          • Ken Takeuchi
        • Contact:
          • Phone Number: 81120023812
      • Osaka, Japan, 540-0006
        • Recruiting
        • National Hospital Organization Osaka National Hospital
        • Principal Investigator:
          • Yuko Sakakibara
        • Contact:
          • Phone Number: 81120023812
      • Sakura, Japan, 285-8741
        • Recruiting
        • Toho University Sakura Medical Center
        • Principal Investigator:
          • Katsuyoshi Matsuoka
        • Contact:
          • Phone Number: 81120023812
      • Sapporo, Japan, 004-0041
        • Recruiting
        • Sapporo Tokushukai Hospital
        • Principal Investigator:
          • Toshifumi Ashida
        • Contact:
          • Phone Number: 81120023812
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Not yet recruiting
        • Scientia Investigacion Clinica S.C.
        • Principal Investigator:
          • Karina Ramirez
      • Durango, Mexico, 34000
        • Not yet recruiting
        • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
        • Principal Investigator:
          • LUIS CARLOS DIAZ HERRERA
      • Guadajalara, Mexico, 44600
        • Not yet recruiting
        • Boca Clinical Trials Mexico S.C.
        • Contact:
          • Phone Number: 3338306672
        • Principal Investigator:
          • Christian Jaramillo Buendía
      • Guadalajara, Mexico, 44650
        • Not yet recruiting
        • Clinica de Investigacion en Reumatologia y Obesidad S. C.
        • Principal Investigator:
          • Hector Martinez Torres
      • Mexico City, Mexico, 04100
        • Not yet recruiting
        • Centro de Investigacion Clinica Chapultepec
        • Principal Investigator:
          • Elda Rodriguez Negrete
      • Mexico City, Mexico, 14080
        • Not yet recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Principal Investigator:
          • JESUS YAMAMOTO-FURUSHO
      • Mexico City, Mexico, 03330
        • Recruiting
        • Centro de Investigación y Gastroenterología - S.C.
        • Contact:
          • Phone Number: 5510546591
        • Principal Investigator:
          • Alma Ladron de Guevara Cetina
      • San Pedro Garza García, Mexico, 66220
        • Recruiting
        • Servicios de Oncología Médica Integral - Monterrey
        • Principal Investigator:
          • Manuel Martinez Vazquez
      • Tijuana, Mexico, 22105
        • Not yet recruiting
        • Scientia Investigacion Clinica S.C.
        • Principal Investigator:
          • Luis Lopez
      • Tlalnepantla, Mexico, 54055
        • Not yet recruiting
        • Clinical Research Institute S.C.
        • Contact:
          • Phone Number: 52 55 53627780
        • Principal Investigator:
          • Leticia Marin
      • Tlalpan, Mexico, 14050
        • Not yet recruiting
        • Medimanage Research
        • Principal Investigator:
          • Ylse Gutiérrez-Grobe
      • Veracruz, Mexico, 91900
        • Not yet recruiting
        • FAICIC S. de R.L. de C.V.
        • Principal Investigator:
          • Aracely Cruz Palacios
        • Contact:
          • Phone Number: 2299327808
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Not yet recruiting
        • Radboudumc
        • Principal Investigator:
          • Marjolijn Duijvestein
        • Contact:
          • Phone Number: +31 24 3619190
      • Tilburg, Netherlands, 5022 GC
        • Not yet recruiting
        • Elisabeth-Tweesteden Ziekenhuis
        • Principal Investigator:
          • Robert Laheij
        • Contact:
          • Phone Number: 0031(0)132218466
  • Poland
      • Katowice, Poland, 40-600
        • Recruiting
        • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
        • Principal Investigator:
          • Marek Olakowski
      • Piotrkow Trybunalski, Poland, 97-300
        • Recruiting
        • IRMED
        • Principal Investigator:
          • Katarzyna Ostrowska
      • Poznan, Poland, 60-192
        • Recruiting
        • Pratia Poznan
        • Principal Investigator:
          • Magdalena Andrzejewska
      • Poznan, Poland, 60-354
        • Not yet recruiting
        • Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
        • Contact:
          • Phone Number: 618547552
        • Principal Investigator:
          • Piotr Eder
      • Szczecin, Poland, 71-434
        • Not yet recruiting
        • Twoja Przychodnia SCM
        • Principal Investigator:
          • Beata Gawdis-Wojnarska
        • Contact:
          • Phone Number: 48 91 433 29 19
      • Szczecin, Poland, 71-685
        • Recruiting
        • Sonomed Sp. z o. o.
        • Principal Investigator:
          • Anna Wiechowska-Kozlowska
      • Warsaw, Poland, 02-786
        • Recruiting
        • WSD Medi
        • Principal Investigator:
          • Michal Krogulecki
        • Contact:
          • Phone Number: +48 504 440 092
      • Warsaw, Poland, 04-501
        • Recruiting
        • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
          • Phone Number: 500111648
      • Zamość, Poland, 22-400
        • Recruiting
        • ETG Zamosc
        • Principal Investigator:
          • Katarzyna Wojcik
        • Contact:
          • Phone Number: 48606930022
  • Romania
      • Bucharest, Romania, 020125
        • Recruiting
        • Spitalul Clinic Colentina
        • Principal Investigator:
          • Bogdan Mateescu
        • Contact:
          • Phone Number: 0213152590
      • Bucharest, Romania, 014142
        • Recruiting
        • Delta Health Care
        • Principal Investigator:
          • Camelia Chioncel
        • Contact:
          • Phone Number: 40745086735
      • Bucharest, Romania, 013823
        • Not yet recruiting
        • Spitalul de Oncologie Monza
        • Contact:
          • Phone Number: 0723527258
        • Principal Investigator:
          • EUGENIU CRACIUN
      • Constanța, Romania, 900591
        • Recruiting
        • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
        • Principal Investigator:
          • Eugen Dumitru
        • Contact:
          • Phone Number: +40744761454
      • Satu Mare, Romania, 440055
        • Recruiting
        • Spital Judetean de Urgenta
        • Contact:
          • Phone Number: +40747 170 170
        • Principal Investigator:
          • Bogdan Pintea
      • Timișoara, Romania, 300002
        • Recruiting
        • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
        • Principal Investigator:
          • Adrian Goldis
        • Contact:
          • Phone Number: 0040722410712
  • Spain
      • Barcelona, Spain, 08022
        • Recruiting
        • Centro Médico Teknon
        • Principal Investigator:
          • Miquel Sans Cuffi
      • Fuenlabrada, Spain, 28942
        • Not yet recruiting
        • Hospital Universitario de Fuenlabrada
        • Contact:
          • Phone Number: 34916006175
        • Principal Investigator:
          • Fernando Bermejo San José
      • Gijón, Spain, 33394
        • Not yet recruiting
        • Hospital de Cabuenes
        • Principal Investigator:
          • Pilar Varela Trastoy
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • MARIA DOLORES MARTIN ARRANZ
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye)
        • Not yet recruiting
        • Adana City Hospital
        • Principal Investigator:
          • BANU KARA
      • Ankara, Turkey (Türkiye), 06560
        • Not yet recruiting
        • Gazi University Health Research and Application Center Gazi Hospital
        • Principal Investigator:
          • Tarkan Karakan
        • Contact:
          • Phone Number: 0 505 319 22 57
      • Antalya, Turkey (Türkiye), 07100
        • Not yet recruiting
        • Antalya Egitim ve Arastırma Hastanesi
        • Principal Investigator:
          • Ayhan Hilmi Cekin
      • Eskişehir, Turkey (Türkiye), 26480
        • Not yet recruiting
        • Eskişehir Osmangazi University
        • Principal Investigator:
          • Tuncer Temel
      • Hatay, Turkey (Türkiye), 31030
        • Not yet recruiting
        • Mustafa Kemal Universitesi
        • Principal Investigator:
          • Mehmet Demir
      • Malatya, Turkey (Türkiye), 44280
        • Not yet recruiting
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
        • Principal Investigator:
          • Yasir Cagin
      • Mersin, Turkey (Türkiye), 33110
        • Not yet recruiting
        • Mersin University
        • Principal Investigator:
          • Engin Altintas
        • Contact:
          • Phone Number: 905326145276
      • Sur, Turkey (Türkiye), 21200
        • Not yet recruiting
        • Dicle Üniversitesi
        • Contact:
          • Phone Number: 05323724782
        • Principal Investigator:
          • Kendal Yalcin
      • İzmit, Turkey (Türkiye), 41380
        • Not yet recruiting
        • Kocaeli University Medical Faculty Hospital
        • Principal Investigator:
          • Hasan Yilmaz
        • Contact:
          • Phone Number: 0090 505 877 48 21
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Not yet recruiting
        • Mayo Clinic in Arizona - Scottsdale
        • Contact:
          • Phone Number: 480-301-8000
        • Principal Investigator:
          • Manreet Kaur
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Clinnova Research - Anaheim
        • Principal Investigator:
          • Amit Bhanvadia
      • Lancaster, California, United States, 93534
        • Recruiting
        • Om Research LLC
        • Principal Investigator:
          • Jatinder Pruthi
        • Contact:
          • Phone Number: 661-388-2239
      • Los Angeles, California, United States, 90035
        • Recruiting
        • Biopharma Informatic, LLC
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Morris Silver, MD
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Peak Gastroenterology Associates
        • Principal Investigator:
          • Bhaktasharan Patel
        • Contact:
          • Phone Number: 719-310-6719
    • Florida
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Neoclinical Research
        • Principal Investigator:
          • Isaac Bassan
        • Contact:
          • Phone Number: 305-456-9062
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Encore Borland-Groover Clinical Research
        • Contact:
          • Phone Number: 904-680-0871
        • Principal Investigator:
          • Kyle Etzkorn
      • Kissimmee, Florida, United States, 34741
        • Recruiting
        • Clinical Research of Osceola
        • Principal Investigator:
          • Basher Atiquzzaman
        • Contact:
          • Phone Number: 407-954-4016
      • Lakewood Rch, Florida, United States, 34211
        • Recruiting
        • Florida Research Institute
        • Contact:
          • Phone Number: 941-727-7772
        • Principal Investigator:
          • Manuel Rodriguez
      • Lighthouse PT, Florida, United States, 33064
        • Recruiting
        • Alliance Medical Research
        • Contact:
          • Phone Number: 954-428-2480
        • Principal Investigator:
          • Vipin Gupta
      • Margate, Florida, United States, 33063
        • Recruiting
        • Atlantic Medical Research
        • Contact:
          • Phone Number: 954-850-0589
        • Principal Investigator:
          • Peter Gach
      • Orlando, Florida, United States, 32825
        • Recruiting
        • Digestive and Liver Center of Florida
        • Contact:
          • Phone Number: 407-384-7388
        • Principal Investigator:
          • Harinath Sheela
    • Illinois
      • Belleville, Illinois, United States, 62223
        • Not yet recruiting
        • Center for Gastrointestinal Health - Fairview Heights
        • Principal Investigator:
          • SHAKEEL AHMED
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern University
        • Principal Investigator:
          • Keith Summa
        • Contact:
          • Phone Number: 312-695-4077
      • Des Plaines, Illinois, United States, 60016
        • Recruiting
        • Midtown Gastroenterology and Liver Disease
        • Contact:
          • Phone Number: 262-925-1280
        • Principal Investigator:
          • John Agaiby
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • GI Alliance - Glenview
        • Principal Investigator:
          • Nina Merel
      • Gurnee, Illinois, United States, 60031
        • Recruiting
        • Gi Alliance - Gurnee
        • Principal Investigator:
          • Jonathan A. Rosenberg
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Gastroenterology Health Partners
        • Contact:
          • Phone Number: 812-206-1702
        • Principal Investigator:
          • Robert Luckett
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Recruiting
        • Gastroenterology Health Partners
        • Principal Investigator:
          • Michael Krease
        • Contact:
          • Phone Number: 502-888-1988
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
          • Phone Number: 617-732-6389
        • Principal Investigator:
          • Jessica Allegretti
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Clinical Research Institute of Michigan, LLC
        • Contact:
          • Phone Number: 586-598-3329
        • Principal Investigator:
          • Mohanad Suede
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • GI Associates - GIA and Endoscopy Center - Flowood
        • Contact:
          • Phone Number: 601-863-0395
        • Principal Investigator:
          • Ralph Vance
    • New York
      • Utica, New York, United States, 13502
        • Recruiting
        • Digestive Disease Medicine of Central New York
        • Principal Investigator:
          • Harvey Allen
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gastroenterology & Hepatology Specialists
        • Contact:
          • Phone Number: 330-305-2020
        • Principal Investigator:
          • Zuoliang Xiao
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Gastroenterology, LLC
        • Contact:
          • Phone Number: 937-320-5050
        • Principal Investigator:
          • Drew Triplett
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Recruiting
        • University Gastroenterology - Providence - West River Street
        • Principal Investigator:
          • Jason Ferreira
        • Contact:
          • Phone Number: 401-227-8393
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Gastroenterology Associates, P.A. of Greenville
        • Principal Investigator:
          • Matthew Barnes
        • Contact:
          • Phone Number: 864-451-5026
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Gastro One - Walnut Run Road
        • Principal Investigator:
          • Ziad Younes
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Recruiting
        • Texas Digestive Disease Consultants - Cedar Park
        • Principal Investigator:
          • Junaid Siddiqui
        • Contact:
          • Phone Number: 512-341-0900
      • Dallas, Texas, United States, 75246
        • Suspended
        • GI Alliance - Dallas - Gaston Avenue
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • GI Alliance - Fort Worth
        • Principal Investigator:
          • Kumar Gutta
        • Contact:
          • Phone Number: 817-612-5575
      • Garland, Texas, United States, 75044
        • Recruiting
        • GI Alliance - Garland
        • Principal Investigator:
          • Harry Sarles
        • Contact:
          • Phone Number: 972-265-8201
      • Lubbock, Texas, United States, 79410
        • Recruiting
        • GI Alliance - Lubbock
        • Principal Investigator:
          • Adam Hughston
        • Contact:
          • Phone Number: 806-793-3141
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute
        • Contact:
          • Phone Number: 210-581-2812
        • Principal Investigator:
          • Jeff Bullock
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Tyler Research Institute
        • Principal Investigator:
          • George DuVall
        • Contact:
          • Phone Number: 903-630-6211
      • Webster, Texas, United States, 77598
        • Recruiting
        • GI Alliance-Webster
        • Contact:
          • Phone Number: 281-626-7035
        • Principal Investigator:
          • Ravi Mani
    • Utah
      • Ogden, Utah, United States, 84403
        • Recruiting
        • Care Access - Ogden
        • Principal Investigator:
          • Chad Gonzales
        • Contact:
          • Phone Number: 801-614-0010
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Clinical Research Partners, LLC
        • Principal Investigator:
          • Kara Foster-Weiss
      • Richmond, Virginia, United States, 23229
        • Recruiting
        • GI Alliance - Richmond
        • Principal Investigator:
          • Omer Khalid
        • Contact:
          • Phone Number: 804-362-0954
      • Roanoke, Virginia, United States, 24014
        • Not yet recruiting
        • Carilion Clinic
        • Principal Investigator:
          • Lana Wahid
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Washington Gastroenterology - Bellevue
        • Contact:
          • Phone Number: 425-454-4768
        • Principal Investigator:
          • Nicholas Procaccini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 and 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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY4268989 + Mirikizumab
LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2.
Drug: LY4268989
Administered PO
Other Names:
  • MORF-057
  • zotemtegrast
Drug: Mirikizumab
Administered IV then SC
Other Names:
  • LY3074828
Experimental: Mirikizumab + LY4268989 Placebo
Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.
Drug: Mirikizumab
Administered IV then SC
Other Names:
  • LY3074828
Drug: LY4268989 Placebo
Administered PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
Time Frame: Week 12

The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES).

Clinical remission (mMS) is defined as:

  • SF subscore = 0 or 1 and no greater than baseline
  • RB subscore = 0
  • Centrally read ES = 0 or 1; score of 1 modified to exclude friability
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Achieve Endoscopic Improvement
Time Frame: Week 12
Week 12
Percentage of Participants Who Achieve Symptomatic Remission
Time Frame: Week 12
Week 12
Percentage of Participants Who Achieve Clinical Remission with mMS
Time Frame: Week 24
Week 24
Percentage of Participants Who Achieve Clinical Response with mMS
Time Frame: Week 24
Week 24
Percentage of Participants Who Achieve Clinical Response with mMS
Time Frame: Week 12
Week 12
Percentage of Participants Who Achieve Clinical Remission with mMS
Time Frame: Week 48
Week 48
Percentage of Participants Who Achieve Clinical Response with mMS
Time Frame: Week 48
Week 48
Percentage of Participants Who Achieve Clinical Remission with mMS + Physician's Global Assessment (PGA)
Time Frame: Week 48
Week 48
Percentage of Participants Who Achieve Clinical Response with mMS + PGA
Time Frame: Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

September 16, 2025

First Submitted That Met QC Criteria

September 16, 2025

First Posted (Actual)

September 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27704
  • MORF-057 (Other Identifier: Eli Lilly and Company)
  • J6E-MC-KWAN (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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