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New combo pill aims to tame stubborn ulcerative colitis

NCT ID NCT07186101

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 9 times

Summary

This study tests whether adding a new oral drug, LY4268989, to the existing treatment mirikizumab works better than mirikizumab alone for adults with moderate-to-severe ulcerative colitis. About 252 participants will receive either the combination or mirikizumab plus a placebo for up to 104 weeks. The main goal is to see if more people achieve remission with the combination.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4268989 (also called MORF-057 or zotemtegrast) and mirikizumab
What this could lead to
If successful, this combination could offer a more effective treatment option for people with moderate-to-severe ulcerative colitis, potentially improving remission rates.
What could go wrong
This is a Phase 2 trial, so it is still early. The combination may not work better than mirikizumab alone, and side effects are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 252 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    147 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    NOT_YET_RECRUITING

    Milan, 20162, Italy

  • Aalborg Universitetshospital, Syd

    RECRUITING

    Gistrup, 9260, Denmark

  • Adana City Hospital

    NOT_YET_RECRUITING

    Adana, Turkey (Türkiye)

  • All India Institute of Medical Sciences

    NOT_YET_RECRUITING

    New Delhi, 110029, India

  • Alliance Medical Research

    RECRUITING

    Lighthouse PT, Florida, 33064, United States

  • Antalya Egitim ve Arastırma Hastanesi

    NOT_YET_RECRUITING

    Antalya, 07100, Turkey (Türkiye)

  • Ashwin Hospital

    RECRUITING

    Coimbatore, 641012, India

  • Atlantic Medical Research

    RECRUITING

    Margate, Florida, 33063, United States

  • BRA - Clínica Médica e Terapia Assistida

    RECRUITING

    Tajaí, 88301-220, Brazil

  • Biopharma Informatic, LLC

    RECRUITING

    Los Angeles, California, 90035, United States

  • Boca Clinical Trials Mexico S.C.

    RECRUITING

    Guadajalara, 44600, Mexico

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

    RECRUITING

    Békéscsaba, 5600, Hungary

  • C.I.C. Mauricie inc.

    RECRUITING

    Trois-Rivières, G8T 7A1, Canada

  • CAEP - Synvia Labs

    RECRUITING

    Campinas, 13087-567, Brazil

  • CPQuali Pesquisa Clínica

    RECRUITING

    São Paulo, 01228-000, Brazil

  • Care Access - Ogden

    RECRUITING

    Ogden, Utah, 84403, United States

  • Carilion Clinic

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Center for Gastrointestinal Health - Fairview Heights

    NOT_YET_RECRUITING

    Belleville, Illinois, 62223, United States

  • Centro Digestivo de Curitiba

    RECRUITING

    Curitiba, 80430-180, Brazil

  • Centro Internacional de Pesquisa Clínica (CIPES)

    RECRUITING

    São José dos Campos, 12230-001, Brazil

  • Centro Médico Teknon

    RECRUITING

    Barcelona, 08022, Spain

  • Centro de Investigación Clinica Chapultepec

    NOT_YET_RECRUITING

    Mexico City, 04100, Mexico

  • Centro de Investigación y Gastroenterología - S.C.

    RECRUITING

    Mexico City, 03330, Mexico

  • Changzhou Second People's Hospital

    RECRUITING

    Changzhou, 213000, China

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    RECRUITING

    Berlin, 10117, Germany

  • Charlton Digestive Disease Centre

    RECRUITING

    Hamilton, L8N 1Y2, Canada

  • Chongqing General Hospital

    RECRUITING

    Chongqing, 401147, China

  • Chronos Pesquisa Clínica

    RECRUITING

    Brasília, 72145-450, Brazil

  • Clinexpert Gyöngyös

    RECRUITING

    Gyöngyös, 3200, Hungary

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

    NOT_YET_RECRUITING

    Guadalajara, 44650, Mexico

  • Clinical Research Institute S.C.

    RECRUITING

    Tlalnepantla, 54055, Mexico

  • Clinical Research Institute of Michigan, LLC

    RECRUITING

    Clinton Township, Michigan, 48038, United States

  • Clinical Research Partners, LLC

    RECRUITING

    Richmond, Virginia, 23226, United States

  • Clinical Research of Osceola

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Clinnova Research - Anaheim

    RECRUITING

    Anaheim, California, 92805, United States

  • Clínica Hepatogastro JK

    RECRUITING

    São Paulo, 04543-011, Brazil

  • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

    RECRUITING

    Constanța, 900591, Romania

  • Dayton Gastroenterology, LLC

    RECRUITING

    Dayton, Ohio, 45415, United States

  • Delta Health Care

    RECRUITING

    Bucharest, 014142, Romania

  • Dicle Üniversitesi

    RECRUITING

    Sur, 21200, Turkey (Türkiye)

  • Digestive Disease Medicine of Central New York

    RECRUITING

    Utica, New York, 13502, United States

  • Digestive and Liver Center of Florida

    RECRUITING

    Orlando, Florida, 32825, United States

  • ETG Zamość

    RECRUITING

    Zamość, 22-400, Poland

  • Elisabeth-TweeSteden Ziekenhuis

    RECRUITING

    Tilburg, 5022 GC, Netherlands

  • Encore Borland-Groover Clinical Research

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Eskisehir Osmangazi University

    RECRUITING

    Eskişehir, 26480, Turkey (Türkiye)

  • FAICIC S. de R.L. de C.V.

    RECRUITING

    Veracruz, 91900, Mexico

  • First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, 650032, China

  • Florida Research Institute

    RECRUITING

    Lakewood Rch, Florida, 34211, United States

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Fukuoka University Hospital

    RECRUITING

    Fukuoka, 814-0180, Japan

  • Fundação Universidade de Caxias do Sul (FUCS)

    RECRUITING

    Caxias do Sul, 95070-560, Brazil

  • GI Alliance - Dallas - Gaston Avenue

    NOT_YET_RECRUITING

    Dallas, Texas, 75246, United States

  • GI Alliance - Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • GI Alliance - Garland

    RECRUITING

    Garland, Texas, 75044, United States

  • GI Alliance - Glenview

    RECRUITING

    Glenview, Illinois, 60026, United States

  • GI Alliance - Lubbock

    RECRUITING

    Lubbock, Texas, 79410, United States

  • GI Alliance - Richmond

    RECRUITING

    Richmond, Virginia, 23229, United States

  • GI Alliance-Webster

    RECRUITING

    Webster, Texas, 77598, United States

  • GI Associates - GIA and Endoscopy Center - Flowood

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Galileo Medical Research

    RECRUITING

    Juiz de Fora, 36033-318, Brazil

  • Gastro One - Walnut Run Road

    RECRUITING

    Cordova, Tennessee, 38018, United States

  • Gastroenterology Associates, P.A. of Greenville

    RECRUITING

    Greenville, South Carolina, 29607, United States

  • Gastroenterology Health Partners

    RECRUITING

    New Albany, Indiana, 47150, United States

  • Gastroenterology Health Partners

    RECRUITING

    Louisville, Kentucky, 40218, United States

  • Gazi University Health Research and Application Center Gazi Hospital

    RECRUITING

    Ankara, 06560, Turkey (Türkiye)

  • Gi Alliance - Gurnee

    RECRUITING

    Gurnee, Illinois, 60031, United States

  • Gokeikai Ofuna Chuo Hospital

    RECRUITING

    Kamakura, 247-0056, Japan

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

    RECRUITING

    Katowice, 40-600, Poland

  • Herlev and Gentofte Hospital

    RECRUITING

    Copenhagen, 2730, Denmark

  • Hospital Ernesto Dornelles

    RECRUITING

    Porto Alegre, 90160-092, Brazil

  • Hospital Santa Catarina - Paulista

    NOT_YET_RECRUITING

    São Paulo, 01310-000, Brazil

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario de Fuenlabrada

    NOT_YET_RECRUITING

    Fuenlabrada, 28942, Spain

  • Hospital de Cabueñes

    RECRUITING

    Gijón, 33394, Spain

  • Humanitas

    NOT_YET_RECRUITING

    Rozzano, 20089, Italy

  • IRMED

    RECRUITING

    Piotrkow Trybunalski, 97-300, Poland

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    NOT_YET_RECRUITING

    Mexico City, 14080, Mexico

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

    RECRUITING

    Durango, 34000, Mexico

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, 210029, China

  • Jávorszky Ödön Kórház

    RECRUITING

    Vác, 2600, Hungary

  • Kocaeli University Medical Faculty Hospital

    RECRUITING

    İzmit, 41380, Turkey (Türkiye)

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    RECRUITING

    Tatabánya, 2800, Hungary

  • London Digestive Disease Institute

    RECRUITING

    London, N6K 1M6, Canada

  • London Health Sciences Centre

    NOT_YET_RECRUITING

    London, N6A 5W9, Canada

  • Mahavir Hospital & Research Centre - Hyderabad

    RECRUITING

    Hyderabad, 500004, India

  • Mayo Clinic in Arizona - Scottsdale

    RECRUITING

    Scottsdale, Arizona, 85259, United States

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

    RECRUITING

    Warsaw, 04-501, Poland

  • Medimanage Research

    RECRUITING

    Tlalpan, 14050, Mexico

  • Medipoint Hospitals Pvt. Ltd.

    RECRUITING

    Pune, 411007, India

  • Medizinische Universität Wien

    RECRUITING

    Vienna, 1090, Austria

  • Mersin University

    RECRUITING

    Mersin, 33110, Turkey (Türkiye)

  • Midtown Gastroenterology and Liver Disease

    RECRUITING

    Des Plaines, Illinois, 60016, United States

  • Mustafa Kemal Universitesi

    RECRUITING

    Hatay, 31030, Turkey (Türkiye)

  • National Hospital Organization Osaka National Hospital

    RECRUITING

    Osaka, 540-0006, Japan

  • NeoClinical Research

    RECRUITING

    Hialeah, Florida, 33016, United States

  • NewData Clinical Research - Maceió

    RECRUITING

    Maceió, 57020-360, Brazil

  • Northwestern University

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Odense Universitetshospital

    RECRUITING

    Odense, 5000, Denmark

  • Om Research LLC

    RECRUITING

    Lancaster, California, 93534, United States

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Pannónia Magánorvosi Centrum

    RECRUITING

    Budapest, 1136, Hungary

  • Peak Gastroenterology Associates

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Pratia Poznań

    RECRUITING

    Poznan, 60-192, Poland

  • Radboudumc

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Rajiv Gandhi Government General Hospital

    RECRUITING

    Chennai, 600003, India

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

    RECRUITING

    Timișoara, 300002, Romania

  • Sapporo Tokushukai Hospital

    RECRUITING

    Sapporo, 004-0041, Japan

  • Sardar Vallabhbhai Patel Institute of Medical Sciences and Research

    RECRUITING

    Ahmedabad, 380006, India

  • Scientia Investigacion Clinica S.C.

    RECRUITING

    Chihuahua City, 31207, Mexico

  • Scientia Investigacion Clinica S.C.

    RECRUITING

    Tijuana, 22105, Mexico

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1088, Hungary

  • Servicios de Oncología Médica Integral - Monterrey

    RECRUITING

    San Pedro Garza García, 66220, Mexico

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, 110004, China

  • Shree Giriraj Multispeciality Hospital

    RECRUITING

    Rajkot, 360005, India

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

    RECRUITING

    Hangzhou, 310018, China

  • Solare Trials

    SUSPENDED

    São Paulo, 01307-002, Brazil

  • Sonomed Sp. z o. o.

    RECRUITING

    Szczecin, 71-685, Poland

  • Southern Star Research Institute

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Spital Judetean de Urgenta

    RECRUITING

    Satu Mare, 440055, Romania

  • Spitalul Clinic Colentina

    RECRUITING

    Bucharest, 020125, Romania

  • Studienzentrum MVZ Dachau

    RECRUITING

    Dachau, 85221, Germany

  • Sushruta Multispeciality Hospital & Research Centre

    RECRUITING

    Hubli, 580021, India

  • Taian City Central Hospital

    RECRUITING

    Taian, 271000, China

  • Texas Digestive Disease Consultants - Cedar Park

    RECRUITING

    Cedar Park, Texas, 78613, United States

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, 266003, China

  • The First Affiliated Hospital Of Fujian Medical University

    RECRUITING

    Fuzhou, 350005, China

  • The Second Afilliated Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, 050000, China

  • Toho University Sakura Medical Center

    RECRUITING

    Sakura, 285-8741, Japan

  • Tsujinaka Hospital - Kashiwanoha

    RECRUITING

    Kashiwa, 277-0871, Japan

  • Twoja Przychodnia SCM

    RECRUITING

    Szczecin, 71-434, Poland

  • Tyler Research Institute

    RECRUITING

    Tyler, Texas, 75701, United States

  • Universidade Federal Do Piaui - Campos Universitario

    RECRUITING

    Teresina, 64049-550, Brazil

  • Universitaetsklinikum Erlangen

    NOT_YET_RECRUITING

    Erlangen, 91054, Germany

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • University Gastroenterology - Providence - West River Street

    RECRUITING

    Providence, Rhode Island, 02904, United States

  • Universitätsklinikum Regensburg

    NOT_YET_RECRUITING

    Regensburg, 93053, Germany

  • Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej

    RECRUITING

    Poznan, 60-354, Poland

  • WSD MEDI

    RECRUITING

    Warsaw, 02-786, Poland

  • Washington Gastroenterology - Bellevue

    RECRUITING

    Bellevue, Washington, 98004, United States

  • West GTA Research Inc.

    RECRUITING

    Mississauga, L5M 2S4, Canada

  • Wuhan Union Hospital

    RECRUITING

    Wuhan, 430022, China

  • Wuxi People's Hospital

    RECRUITING

    Wuxi, 214023, China

  • Óbudai Egészségügyi Centrum

    RECRUITING

    Budapest, 1036, Hungary

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

    RECRUITING

    Malatya, 44280, Turkey (Türkiye)

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