AzTrials
AzTrials

Ulcerative ColitisPhase 2TOPAZ-UCNCT07186101

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

A Phase 2 study testing LY4268989 and Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 147 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
LY4268989 and Mirikizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
147 sitesin 17 countries
Study dates
10 Nov 2025to Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

147 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

147 sites in 17 countries

United States40 sites, 40 recruiting

  • Clinnova Research - Anaheim

    Anaheim, California, 92805

    Amit Bhanvadia

    Recruiting

  • Center for Gastrointestinal Health - Fairview Heights

    Belleville, Illinois, 62223

    SHAKEEL AHMED

    Not yet recruiting

  • Washington Gastroenterology - Bellevue

    Bellevue, Washington, 98004

    425-454-4768

    Nicholas Procaccini

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    617-732-6389

    Jessica Allegretti

    Recruiting

  • Texas Digestive Disease Consultants - Cedar Park

    Cedar Park, Texas, 78613

    512-341-0900

    Junaid Siddiqui

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    312-695-4077

    Keith Summa

    Not yet recruiting

  • Clinical Research Institute of Michigan, LLC

    Clinton Township, Michigan, 48038

    586-598-3329

    Mohanad Suede

    Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

    719-310-6719

    Bhaktasharan Patel

    Recruiting

  • Gastro One - Walnut Run Road

    Cordova, Tennessee, 38018

    Ziad Younes

    Recruiting

  • GI Alliance - Dallas - Gaston Avenue

    Dallas, Texas, 75246

    214-323-8500

    Ben Kahn

    Not yet recruiting

  • Dayton Gastroenterology, LLC

    Dayton, Ohio, 45415

    937-320-5050

    Drew Triplett

    Recruiting

  • Midtown Gastroenterology and Liver Disease

    Des Plaines, Illinois, 60016

    262-925-1280

    John Agaiby

    Recruiting

  • GI Associates - GIA and Endoscopy Center - Flowood

    Flowood, Mississippi, 39232

    601-863-0395

    Ralph Vance

    Recruiting

  • GI Alliance - Fort Worth

    Fort Worth, Texas, 76104

    817-612-5575

    Kumar Gutta

    Recruiting

  • GI Alliance - Garland

    Garland, Texas, 75044

    972-265-8201

    Harry Sarles

    Recruiting

  • GI Alliance - Glenview

    Glenview, Illinois, 60026

    Nina Merel

    Recruiting

  • Gastroenterology Associates, P.A. of Greenville

    Greenville, South Carolina, 29607

    864-451-5026

    Matthew Barnes

    Recruiting

  • Gi Alliance - Gurnee

    Gurnee, Illinois, 60031

    Jonathan A. Rosenberg

    Recruiting

  • NeoClinical Research

    Hialeah, Florida, 33016

    305-456-9062

    Isaac Bassan

    Recruiting

  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida, 32256

    904-680-0871

    Kyle Etzkorn

    Recruiting

  • Clinical Research of Osceola

    Kissimmee, Florida, 34741

    407-954-4016

    Basher Atiquzzaman

    Recruiting

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

    941-727-7772

    Manuel Rodriguez

    Recruiting

  • Om Research LLC

    Lancaster, California, 93534

    661-388-2239

    Jatinder Pruthi

    Recruiting

  • Alliance Medical Research

    Lighthouse PT, Florida, 33064

    954-428-2480

    Vipin Gupta

    Recruiting

  • Biopharma Informatic, LLC

    Los Angeles, California, 90035

    281-944-3610

    Morris Silver, MD

    Recruiting

  • Gastroenterology Health Partners

    Louisville, Kentucky, 40218

    502-888-1988

    Michael Krease

    Recruiting

  • GI Alliance - Lubbock

    Lubbock, Texas, 79410

    806-793-3141

    Adam Hughston

    Recruiting

  • Atlantic Medical Research

    Margate, Florida, 33063

    954-850-0589

    Peter Gach

    Recruiting

  • Gastroenterology Health Partners

    New Albany, Indiana, 47150

    812-206-1702

    Robert Luckett

    Recruiting

  • Care Access - Ogden

    Ogden, Utah, 84403

    801-614-0010

    Chad Gonzales

    Recruiting

  • Digestive and Liver Center of Florida

    Orlando, Florida, 32825

    407-384-7388

    Harinath Sheela

    Recruiting

  • University Gastroenterology - Providence - West River Street

    Providence, Rhode Island, 02904

    401-227-8393

    Jason Ferreira

    Recruiting

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

    Kara Foster-Weiss

    Recruiting

  • GI Alliance - Richmond

    Richmond, Virginia, 23229

    804-362-0954

    Omer Khalid

    Recruiting

  • Carilion Clinic

    Roanoke, Virginia, 24014

    Lana Wahid

    Recruiting

  • Southern Star Research Institute

    San Antonio, Texas, 78229

    210-581-2812

    Jeff Bullock

    Recruiting

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, Arizona, 85259

    480-301-8000

    Manreet Kaur

    Recruiting

  • Tyler Research Institute

    Tyler, Texas, 75701

    903-630-6211

    George DuVall

    Recruiting

  • Digestive Disease Medicine of Central New York

    Utica, New York, 13502

    Harvey Allen

    Recruiting

  • GI Alliance-Webster

    Webster, Texas, 77598

    281-626-7035

    Ravi Mani

    Recruiting

Other trials in United States

Brazil14 sites, 13 recruiting

  • Chronos Pesquisa Clínica

    Brasília, 72145-450

    61999780700

    Cintia Mendes Clemente

    Recruiting

  • CAEP - Synvia Labs

    Campinas, 13087-567

    Leandro Negreiros

    Recruiting

  • Fundação Universidade de Caxias do Sul (FUCS)

    Caxias do Sul, 95070-560

    Eduardo Brambilla

    Recruiting

  • Centro Digestivo de Curitiba

    Curitiba, 80430-180

    +55 41 3322-1115

    Odery Ramos Júnior

    Recruiting

  • Galileo Medical Research

    Juiz de Fora, 36033-318

    Julio Chebli

    Recruiting

  • NewData Clinical Research - Maceió

    Maceió, 57020-360

    +55 79 98825-9395

    Alex Callado França

    Recruiting

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-092

    +5551999624012

    Cristina Flores

    Recruiting

  • Centro Internacional de Pesquisa Clínica (CIPES)

    São José dos Campos, 12230-001

    Anderson Silva

    Recruiting

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

    +55 11 2776-6801

    Alexandre de Sousa Carlos

    Recruiting

  • Solare Trials

    São Paulo, 01307-002

    Suspended

  • Hospital Santa Catarina - Paulista

    São Paulo, 01310-000

    Daniel da Silva

    Recruiting

  • Clínica Hepatogastro JK

    São Paulo, 04543-011

    5511999158070

    Rodrigo Andrey Rocco

    Recruiting

  • BRA - Clínica Médica e Terapia Assistida

    Tajaí, 88301-220

    Munique Kurtz de Mello

    Recruiting

  • Universidade Federal Do Piaui - Campos Universitario

    Teresina, 64049-550

    +55 86 999813603

    José Miguel Parente

    Recruiting

Other trials in Brazil

China12 sites, 12 recruiting

  • Changzhou Second People's Hospital

    Changzhou, 213000

    Wenjia LIU

    Recruiting

  • Chongqing General Hospital

    Chongqing, 401147

    86-13508389768

    Hong Guo

    Recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, 350005

    86 13178111141

    Chengdang Wang

    Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, 310018

    Qian Cao

    Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, 650032

    Juan Luo

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, 210029

    Hongjie ZHANG

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266003

    Xueli Ding

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

    Lixuan Sang

    Recruiting

  • The Second Afilliated Hospital of Hebei Medical University

    Shijiazhuang, 050000

    Xiaolan Zhang

    Recruiting

  • Taian City Central Hospital

    Taian, 271000

    13375387610

    Haipeng Yuan

    Recruiting

  • Wuhan Union Hospital

    Wuhan, 430022

    Rong LIN

    Recruiting

  • Wuxi People's Hospital

    Wuxi, 214023

    Qunyan Zhou

    Recruiting

Other trials in China

Mexico12 sites, 12 recruiting

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207

    Karina Ramirez

    Recruiting

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000

    LUIS CARLOS DIAZ HERRERA

    Recruiting

  • Boca Clinical Trials Mexico S.C.

    Guadajalara, 44600

    3338306672

    Christian Jaramillo Buendía

    Recruiting

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, 44650

    Hector Martinez Torres

    Not yet recruiting

  • Centro de Investigación y Gastroenterología - S.C.

    Mexico City, 03330

    5510546591

    Alma Ladron de Guevara Cetina

    Recruiting

  • Centro de Investigación Clinica Chapultepec

    Mexico City, 04100

    Elda Rodriguez Negrete

    Not yet recruiting

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

    JESUS YAMAMOTO-FURUSHO

    Not yet recruiting

  • Servicios de Oncología Médica Integral - Monterrey

    San Pedro Garza García, 66220

    Manuel Martinez Vazquez

    Recruiting

  • Scientia Investigacion Clinica S.C.

    Tijuana, 22105

    Luis Lopez

    Recruiting

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055

    52 55 53627780

    Leticia Marin

    Recruiting

  • Medimanage Research

    Tlalpan, 14050

    Enrique Coss Adame

    Recruiting

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900

    2299327808

    Aracely Cruz Palacios

    Recruiting

Other trials in Mexico

Poland9 sites, 9 recruiting

  • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

    Katowice, 40-600

    Marek Olakowski

    Recruiting

  • IRMED

    Piotrkow Trybunalski, 97-300

    Katarzyna Ostrowska

    Recruiting

  • Pratia Poznań

    Poznan, 60-192

    Magdalena Andrzejewska

    Recruiting

  • Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej

    Poznan, 60-354

    618547552

    Piotr Eder

    Recruiting

  • Twoja Przychodnia SCM

    Szczecin, 71-434

    48 91 433 29 19

    Beata Gawdis-Wojnarska

    Recruiting

  • Sonomed Sp. z o. o.

    Szczecin, 71-685

    Anna Wiechowska-Kozlowska

    Recruiting

  • WSD MEDI

    Warsaw, 02-786

    +48 504 440 092

    Michal Krogulecki

    Recruiting

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, 04-501

    500111648

    Jaroslaw Kierkus

    Recruiting

  • ETG Zamość

    Zamość, 22-400

    48606930022

    Katarzyna Wojcik

    Recruiting

Other trials in Poland

Turkey (Türkiye)9 sites, 9 recruiting

  • Adana City Hospital

    Adana

    BANU KARA

    Recruiting

  • Gazi University Health Research and Application Center Gazi Hospital

    Ankara, 06560

    0 505 319 22 57

    Tarkan Karakan

    Recruiting

  • Antalya Egitim ve Arastırma Hastanesi

    Antalya, 07100

    Ayhan Hilmi Cekin

    Not yet recruiting

  • Eskisehir Osmangazi University

    Eskişehir, 26480

    Tuncer Temel

    Recruiting

  • Mustafa Kemal Universitesi

    Hatay, 31030

    Mehmet Demir

    Recruiting

  • Kocaeli University Medical Faculty Hospital

    İzmit, 41380

    0090 505 877 48 21

    Hasan Yilmaz

    Recruiting

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

    Malatya, 44280

    Yasir Cagin

    Recruiting

  • Mersin University

    Mersin, 33110

    905326145276

    Engin Altintas

    Recruiting

  • Dicle Üniversitesi

    Sur, 21200

    05323724782

    Kendal Yalcin

    Recruiting

Other trials in Turkey (Türkiye)

India8 sites, 8 recruiting

  • Sardar Vallabhbhai Patel Institute of Medical Sciences and Research

    Ahmedabad, 380006

    09825005167

    Kaushal Vyas

    Recruiting

  • Rajiv Gandhi Government General Hospital

    Chennai, 600003

    Senthil Ponnaiah

    Recruiting

  • Ashwin Hospital

    Coimbatore, 641012

    Ganesh Muniappan

    Recruiting

  • Sushruta Multispeciality Hospital & Research Centre

    Hubli, 580021

    09448804251

    LAXMIKANT DESAI

    Recruiting

  • Mahavir Hospital & Research Centre - Hyderabad

    Hyderabad, 500004

    Sameer Kumar

    Recruiting

  • All India Institute of Medical Sciences

    New Delhi, 110029

    09867932836

    Vineet Ahuja

    Not yet recruiting

  • Medipoint Hospitals Pvt. Ltd.

    Pune, 411007

    Pankaj Nemade

    Recruiting

  • Shree Giriraj Multispeciality Hospital

    Rajkot, 360005

    Chetan Mehta

    Recruiting

Other trials in India

Hungary7 sites, 7 recruiting

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

    Békéscsaba, 5600

    003666555582

    Marta Varga

    Recruiting

  • Óbudai Egészségügyi Centrum

    Budapest, 1036

    06309399575

    Tamás Toth

    Recruiting

  • Semmelweis Egyetem

    Budapest, 1088

    3612664616

    Zsolt Tulassay

    Recruiting

  • Pannónia Magánorvosi Centrum

    Budapest, 1136

    003613301143

    Robert Schnabel

    Recruiting

  • Clinexpert Gyöngyös

    Gyöngyös, 3200

    +36209650290

    Gyula Horvat

    Recruiting

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800

    36309578269

    András Káfony

    Recruiting

  • Jávorszky Ödön Kórház

    Vác, 2600

    +36302001489

    Tibor Szaloki

    Recruiting

Other trials in Hungary

Japan6 sites, 6 recruiting

  • Fukuoka University Hospital

    Fukuoka, 814-0180

    81120023812

    Fumihito Hirai

    Recruiting

  • Gokeikai Ofuna Chuo Hospital

    Kamakura, 247-0056

    81120023812

    Atsushi Yoshida

    Recruiting

  • Tsujinaka Hospital - Kashiwanoha

    Kashiwa, 277-0871

    81120023812

    Ken Takeuchi

    Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

    81120023812

    Yuko Sakakibara

    Recruiting

  • Toho University Sakura Medical Center

    Sakura, 285-8741

    81120023812

    Katsuyoshi Matsuoka

    Recruiting

  • Sapporo Tokushukai Hospital

    Sapporo, 004-0041

    81120023812

    Toshifumi Ashida

    Recruiting

Other trials in Japan

Canada5 sites, 5 recruiting

  • Charlton Digestive Disease Centre

    Hamilton, L8N 1Y2

    905-526-7002 x 3123

    Neeraj Narula

    Recruiting

  • London Health Sciences Centre

    London, N6A 5W9

    519-685-8500

    Terry Ponich

    Not yet recruiting

  • London Digestive Disease Institute

    London, N6K 1M6

    Vipul Jairath

    Recruiting

  • West GTA Research Inc.

    Mississauga, L5M 2S4

    Arif Yusuf

    Recruiting

  • C.I.C. Mauricie inc.

    Trois-Rivières, G8T 7A1

    Madeleine Bonneviot

    Recruiting

Other trials in Canada

Germany5 sites, 5 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117

    004930450614031

    Christoph Jochum

    Recruiting

  • Studienzentrum MVZ Dachau

    Dachau, 85221

    004981316119311

    Wilfred Landry

    Recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

    Sebastian Zundler

    Not yet recruiting

  • Universitätsklinikum Regensburg

    Regensburg, 93053

    +499419447010

    Arne Kandulski

    Not yet recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    0497315000

    Jochen Klaus

    Recruiting

Other trials in Germany

Italy5 sites, 5 recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Marcello Vangeli

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

    0255032141

    Flavio Caprioli

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Silvio Danese

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    0630154678

    Franco Scaldaferri

    Recruiting

  • Humanitas

    Rozzano, 20089

    0282243263

    Alessandro Armuzzi

    Not yet recruiting

Other trials in Italy

Romania5 sites, 5 recruiting

  • Delta Health Care

    Bucharest, 014142

    40745086735

    Camelia Chioncel

    Recruiting

  • Spitalul Clinic Colentina

    Bucharest, 020125

    0213152590

    Bogdan Mateescu

    Recruiting

  • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

    Constanța, 900591

    +40744761454

    Eugen Dumitru

    Recruiting

  • Spital Judetean de Urgenta

    Satu Mare, 440055

    +40747 170 170

    Bogdan Pintea

    Recruiting

  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

    Timișoara, 300002

    0040722410712

    Adrian Goldis

    Recruiting

Other trials in Romania

Spain4 sites, 4 recruiting

  • Centro Médico Teknon

    Barcelona, 08022

    Miquel Sans Cuffi

    Recruiting

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, 28942

    34916006175

    Fernando Bermejo San José

    Recruiting

  • Hospital de Cabueñes

    Gijón, 33394

    Pilar Varela Trastoy

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    MARIA DOLORES MARTIN ARRANZ

    Recruiting

Other trials in Spain

Denmark3 sites, 3 recruiting

  • Herlev and Gentofte Hospital

    Copenhagen, 2730

    Jakob Seidelin

    Recruiting

  • Aalborg Universitetshospital, Syd

    Gistrup, 9260

    Henrik Jacobsen

    Recruiting

  • Odense Universitetshospital

    Odense, 5000

    Mark Ainsworth

    Recruiting

Other trials in Denmark

Netherlands2 sites, 2 recruiting

  • Radboudumc

    Nijmegen, 6525 GA

    +31 24 3619190

    Marjolijn Duijvestein

    Recruiting

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, 5022 GC

    0031(0)132218466

    Robert Laheij

    Recruiting

Other trials in Netherlands

Austria1 site, 1 recruiting

  • Medizinische Universität Wien

    Vienna, 1090

    004314040062450

    Walter Reinisch

    Recruiting

Other trials in Austria

About this study

Official title: 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.

Being tested
LY4268989, Mirikizumab, LY4268989 Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY4268989Drug

    Also called MORF-057, zotemtegrast

    Administered PO

  • MirikizumabDrug

    Also called LY3074828

    Administered IV then SC

  • LY4268989 PlaceboDrug

    Administered PO

Study groups in NCT07186101
Study groupRoleWhat they receive
LY4268989 + MirikizumabExperimentalLY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2.
Receives: Drug: LY4268989; Drug: Mirikizumab
Mirikizumab + LY4268989 PlaceboExperimentalMirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.
Receives: Drug: Mirikizumab; Drug: LY4268989 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)

    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

    Measured: Week 12

Secondary outcomes (9)

  1. Percentage of Participants Who Achieve Clinical Response with mMS

    Measured: Week 12

  2. Percentage of Participants Who Achieve Endoscopic Improvement

    Measured: Week 12

  3. Percentage of Participants Who Achieve Symptomatic Remission

    Measured: Week 12

  4. Percentage of Participants Who Achieve Clinical Remission with mMS

    Measured: Week 24

  5. Percentage of Participants Who Achieve Clinical Response with mMS

    Measured: Week 24

  6. Percentage of Participants Who Achieve Clinical Remission with mMS

    Measured: Week 48

  7. Percentage of Participants Who Achieve Clinical Response with mMS

    Measured: Week 48

  8. Percentage of Participants Who Achieve Clinical Remission with mMS + Physician's Global Assessment (PGA)

    Measured: Week 48

  9. Percentage of Participants Who Achieve Clinical Response with mMS + PGA

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start10 Nov 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07186101
Sponsor's protocol ID
27704
Other IDs
J6E-MC-KWAN, MORF-057
Acronym
TOPAZ-UC
Status last verified
Oct 2026
First submitted
16 Sep 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY4268989 and Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 147 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Brazil, China, Mexico, Poland and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07186101.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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