RecruitingPhase 2NCT07186101

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

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

Sponsor

Eli Lilly and Company

Enrollment

252 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis

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). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of two drugs — LY4268989 (also known as MORF-057) and mirikizumab — in adults with moderate to severe ulcerative colitis (UC), a condition causing chronic inflammation and sores in the large intestine, who have not responded well to previous treatments. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of moderate to severe ulcerative colitis - Previous medications (such as steroids, immunosuppressants, or biologics) have not worked well enough - You have had a recent colonoscopy confirming active disease **You may NOT be eligible if...** - You have Crohn's disease or only proctitis (inflammation limited to the very end of the bowel) - You have had recent bowel surgery or multiple prior bowel surgeries - You have or have had high-grade precancerous changes in your gut - You are not up to date with colorectal cancer screening Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY4268989

Administered PO

DRUGMirikizumab

Administered IV then SC

DRUGLY4268989 Placebo

Administered PO

Locations(149)

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

Gastroenterology & Hepatology Specialists

Canton, Ohio, United States

Dayton Gastroenterology, LLC

Dayton, Ohio, United States

University Gastroenterology - Providence - West River Street

Providence, Rhode Island, United States

Gastroenterology Associates, P.A. of Greenville

Greenville, South Carolina, United States

Gastro One - Walnut Run Road

Cordova, Tennessee, United States

Texas Digestive Disease Consultants - Cedar Park

Cedar Park, Texas, United States

GI Alliance - Dallas - Gaston Avenue

Dallas, Texas, United States

GI Alliance - Fort Worth

Fort Worth, Texas, United States

GI Alliance - Garland

Garland, Texas, United States

GI Alliance - Lubbock

Lubbock, Texas, United States

Southern Star Research Institute

San Antonio, Texas, United States

Tyler Research Institute

Tyler, Texas, United States

GI Alliance-Webster

Webster, Texas, United States

Care Access - Ogden

Ogden, Utah, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

GI Alliance - Richmond

Richmond, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States

Washington Gastroenterology - Bellevue

Bellevue, Washington, United States

Uniklinikum Salzburg

Salzburg, Austria

Medizinische Universität Wien

Vienna, Austria

Chronos Pesquisa Clínica

Brasília, Brazil

CAEP - Synvia Labs

Campinas, Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, Brazil

Centro Digestivo de Curitiba

Curitiba, Brazil

Galileo Medical Research

Juiz de Fora, Brazil

NewData Clinical Research - Maceió

Maceió, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Brazil

Centro Internacional de Pesquisa Clínica (CIPES)

São José dos Campos, Brazil

CPQuali Pesquisa Clínica

São Paulo, Brazil

Solare Trials

São Paulo, Brazil

Hospital Santa Catarina - Paulista

São Paulo, Brazil

Clínica Hepatogastro JK

São Paulo, Brazil

Universidade Federal Do Piaui - Campos Universitario

Teresina, Brazil

Charlton Digestive Disease Centre

Hamilton, Canada

Victoria Hospital & Children's Hospital - London Health Sciences Centre

London, Canada

London Digestive Disease Institute

London, Canada

West GTA Research Inc.

Mississauga, Canada

C.I.C. Mauricie inc.

Trois-Rivières, Canada

Changzhou Second People's Hospital

Changzhou, China

Chongqing General Hospital

Chongqing, China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, China

First Affiliated Hospital of Kunming Medical University

Kunming, China

Jiangsu Province Hospital

Nanjing, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Shengjing Hospital of China Medical University

Shenyang, China

The Second Afilliated Hospital of Hebei Medical University

Shijiazhuang, China

Taian City Central Hospital

Taian, China

Wuhan Union Hospital

Wuhan, China

Wuxi People's Hospital

Wuxi, China

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

Universitätsklinikum Regensburg

Regensburg, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

Békéscsaba, Hungary

Óbudai Egészségügyi Centrum

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Pannónia Magánorvosi Centrum

Budapest, Hungary

Clinexpert Gyöngyös

Gyöngyös, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, Hungary

Jávorszky Ödön Kórház

Vác, Hungary

Sardar Vallabhbhai Patel Institute of Medical Sciences and Research

Ahmedabad, India

Rajiv Gandhi Government General Hospital

Chennai, India

Ashwin Hospital

Coimbatore, India

Sushruta Multispeciality Hospital & Research Centre

Hubli, India

Mahavir Hospital & Research Centre - Hyderabad

Hyderabad, India

All India Institute of Medical Sciences

New Delhi, India

Medipoint Hospitals Pvt. Ltd.

Pune, India

Shree Giriraj Multispeciality Hospital

Rajkot, India

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Humanitas

Rozzano, Italy

Fukuoka University Hospital

Fukuoka, Japan

Gokeikai Ofuna Chuo Hospital

Kamakura, Japan

Tsujinaka Hospital - Kashiwanoha

Kashiwa, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Toho University Sakura Medical Center

Sakura, Japan

Sapporo Tokushukai Hospital

Sapporo, Japan

Scientia Investigacion Clinica S.C.

Chihuahua City, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, Mexico

Boca Clinical Trials Mexico S.C.

Guadajalara, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Mexico

Centro de Investigación y Gastroenterología - S.C.

Mexico City, Mexico

Centro de Investigación Clinica Chapultepec

Mexico City, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico

Servicios de Oncología Médica Integral - Monterrey

San Pedro Garza García, Mexico

Scientia Investigacion Clinica S.C.

Tijuana, Mexico

Clinical Research Institute S.C.

Tlalnepantla, Mexico

Medimanage Research

Tlalpan, Mexico

FAICIC S. de R.L. de C.V.

Veracruz, Mexico

Radboudumc

Nijmegen, Netherlands

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

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

Katowice, Poland

IRMED

Piotrkow Trybunalski, Poland

Pratia Poznań

Poznan, Poland

Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej

Poznan, Poland

Twoja Przychodnia SCM

Szczecin, Poland

Sonomed Sp. z o. o.

Szczecin, Poland

WSD MEDI

Warsaw, Poland

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

Warsaw, Poland

ETG Zamość

Zamość, Poland

Spitalul de Oncologie Monza

Bucharest, Romania

Delta Health Care

Bucharest, Romania

Spitalul Clinic Colentina

Bucharest, Romania

Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

Constanța, Romania

Spital Judetean de Urgenta

Satu Mare, Romania

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

Timișoara, Romania

Centro Médico Teknon

Barcelona, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Spain

Hospital de Cabueñes

Gijón, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

Adana City Hospital

Adana, Turkey (Türkiye)

Gazi University Health Research and Application Center Gazi Hospital

Ankara, Turkey (Türkiye)

Antalya Egitim ve Arastırma Hastanesi

Antalya, Turkey (Türkiye)

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Mustafa Kemal Universitesi

Hatay, Turkey (Türkiye)

Kocaeli University Medical Faculty Hospital

İzmit, Turkey (Türkiye)

İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

Malatya, Turkey (Türkiye)

Mersin University

Mersin, Turkey (Türkiye)

Dicle Üniversitesi

Sur, Turkey (Türkiye)

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NCT07186101

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