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NCT07415044PHASE2Recruiting

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Eli Lilly and Company

Start Date

3/26/2026

Completion Date

7/1/2031

Summary

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: * Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC * Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1 * Have evidence of UC extending proximal to the rectum * Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years * Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded * Must meet contraception requirements 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 an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation * 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 prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies * Have a diagnosis or history of malignant disease within 5 years prior to randomization

Interventions

DRUG

LY4268989

DRUG

Placebo

Interested in This Trial?

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Conditions

Ulcerative Colitis (UC)Ulcerative Colitis, Active ModerateUlcerative Colitis, Active Severe

Locations

Valleywise Health Medical Center

Phoenix, Arizona 85008

United States

One of a Kind Clinical Research Center

Scottsdale, Arizona 85258

United States

Clinnova Research

Anaheim, California 92805

United States

GMC Clinical Research

Folsom, California 95630

United States

Om Research LLC

Temple City, California 91780

United States

Om Research LLC

Victorville, California 92395

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

Advanced Research Institute - Denver

Denver, Colorado 80218

United States

Rocky Mountain Gastroenterology Associates - Lakewood

Lakewood, Colorado 80228

United States

Medical Research Center of Connecticut

Hamden, Connecticut 06518

United States

K2 Medical Research - Daytona Beach

Daytona Beach, Florida 32114

United States

Clinical Research of Osceola

Kissimmee, Florida 34741

United States

Florida Research Institute

Lakewood Rch, Florida 34211

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

Treasure Valley Medical Research

Boise, Idaho 83706

United States

Grand Teton Research Group

Idaho Falls, Idaho 83404

United States

Northwestern University

Chicago, Illinois 60611

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Midwest Digestive Health & Nutrition

Des Plaines, Illinois 60016

United States

Springfield Clinic - First

Springfield, Illinois 62702

United States

Gastroenterology Health Partners

New Albany, Indiana 47150

United States

Gastroenterology Health Partners

Louisville, Kentucky 40218

United States

GI Alliance - Gastro Group and Endocenter - Mandeville

Mandeville, Louisiana 70471

United States

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

Wyoming, Michigan 49519

United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota 55905

United States

KAD Clinical Research

St Louis, Missouri 63123

United States

Specialists in Gastroenterology

St Louis, Missouri 63141

United States

Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive

Las Vegas, Nevada 89128

United States

Virtua Health & Wellness Center - Moorestown

Moorestown, New Jersey 08057

United States

Saint Peter's University Hospital

New Brunswick, New Jersey 08901

United States

Stony Brook University

Stony Brook, New York 11794

United States

Carolina Digestive Diseases and Endoscopy Center

Greenville, North Carolina 27834

United States

Wilmington Health, PLLC

Wilmington, North Carolina 28401

United States

Ohio State University

Hilliard, Ohio 43026

United States

DSI Research - Springboro

Springboro, Ohio 45066

United States

Gastro Intestinal Research Institute of Northern Ohio, LLC

Westlake, Ohio 44145

United States

The Oregon Clinic

Portland, Oregon 97220

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Sanford USD Medical Center

Sioux Falls, South Dakota 57105

United States

Skyline Gastroenterology of West Tennessee

Jackson, Tennessee 38301

United States

GI Alliance - Fort Worth

Fort Worth, Texas 76104

United States

GI Alliance - Garland

Garland, Texas 75044

United States

Integrity Advanced Therapeutics

Houston, Texas 77090

United States

GI Alliance: Mansfield

Mansfield, Texas 76063

United States

Southern Star Research Institute

San Antonio, Texas 78229

United States

GI Alliance - San Marcos

San Marcos, Texas 78666

United States

Tyler Research Institute

Tyler, Texas 75701

United States

Eximia Research-VA, LLC

Norfolk, Virginia 23502

United States

Swedish Medical Center

Seattle, Washington 98104

United States

Principle Research Solutions

Spokane, Washington 99202

United States

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington 99208

United States

Washington Gastroenterology - Tacoma

Tacoma, Washington 98405

United States

Stat Research S.A.

Buenos Aires, C1023AAB

Argentina

Mautalen Salud e Investigación

Buenos Aires, C1128AAF

Argentina

GEDYT

Buenos Aires, C1425BGC

Argentina

Sanatorio Maipú

Mendoza, 5515

Argentina

CER medical Institute

Quilmes, 1878

Argentina

INECO Neurociencias Oroño

Rosario, 2000

Argentina

Hospital Provincial del Centenario

Rosario, 2002

Argentina

Instituto Médico de Alta Complejidad San Isidro Sa

San Isidro, 1642

Argentina

C.I.C.E. 9 de Julio

San Miguel de Tucumán, 4000

Argentina

Loema Instituto de Pesquisa Clinica

Campinas, 13092-133

Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, 95070-560

Brazil

HNSG

Curitiba,

Brazil

Centro de Oncologia Leonardo Da Vinci - ATO Terapias

Fortaleza, 60140-025

Brazil

Hospital Ernesto Dornelles

Porto Alegre, 90160-092

Brazil

Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador

Salvador, 41920-900

Brazil

Irmandade da Santa Casa da Misericórdia de Santos

Santos, 11075-900

Brazil

BR Trials - Ensaios Clinicos e Consultoria

São Paulo, 01236030

Brazil

Clínica Hepatogastro JK

São Paulo, 04543-011

Brazil

BRA - Clínica Médica e Terapia Assistida

Tajaí, 88301-220

Brazil

Health Sciences North

Greater Sudbury, P3E 5J1

Canada

QEII Health Sciences Centre - Victoria General Site

Halifax, B3H 2Y9

Canada

London Digestive Disease Institute

London, N6K 1M6

Canada

Binzhou Medical University Hospital

Binzhou, 256603

China

Changzhou Second People's Hospital

Changzhou, 213000

China

Sichuan Provincial People's Hospital

Chengdu, 610072

China

Chongqing General Hospital

Chongqing, 401121

China

The First People's Hospital of Foshan

Foshan, 528041

China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510655

China

Heilongjiang Provincial Hospital

Harbin, 150036

China

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022

China

Huizhou Central People's Hospital

Huizhou, 516001

China

First Affiliated Hospital of Kunming Medical University

Kunming, 650032

China

Liaocheng People's Hospital

Liaocheng, 252000

China

Meihekou Central Hospital

Meihekou, 135000

China

The Affiliated Hospital of Qingdao University

Qingdao, 266003

China

Shanghai Tenth People's Hospital

Shanghai, 200072

China

Shanghai Pudong New District Zhoupu Hospital

Shanghai, 201318

China

Yuebei People's Hospital Guangdong

Shaoguan, 512026

China

Peking University Shenzhen Hospital

Shenzhen, 518036

China

The First Affiliated Hospital of Soochow University

Suzhou, 215006

China

Taian City Central Hospital

Taian, 271000

China

Wuhan Union Hospital

Wuhan, 430022

China

Renmin Hospital of Wuhan University

Wuhan, 430060

China

Zunyi Medical College - No.1 Affiliated Hospital

Zunyi, 563003

China

Clinica de la Costa S.A.S.

Barranquilla, 080020

Colombia

Fundacion Santa Fe de Bogota

Bogotá, 110111

Colombia

Hospital Universitario Mayor Méderi

Bogotá, 111411

Colombia

Hospital Universitario San Ignacio

Bogotá,

Colombia

Hospital Pablo Tobon Uribe

Medellín, 050034

Colombia

Opća bolnica Bjelovar

Bjelovar, 43000

Croatia

Poliklinika Borzan

Osijek, 31000

Croatia

Klinički Bolnički Centar Split

Split, 21000

Croatia

Klinički bolnički centar Zagreb

Zagreb, 10000

Croatia

Hepato-Gastroenterologie HK

Hradec Králové, 500 12

Czechia

Nemocnice Pardubického kraje

Pardubice, 532 03

Czechia

Clinoxus

Prague, 140 00

Czechia

MEDICON

Prague, 140 00

Czechia

ISCARE klinické centrum

Prague, 19000

Czechia

Nemocnice Slany

Slaný, 274 01

Czechia

Nemocnice AGEL Šternberk

Sternberk, 785 01

Czechia

Clinical Trials Service s.r.o.

Uherské Hradiště, 686 01

Czechia

Gastro-nell

Vsetín, 755 01

Czechia

Centres Médico Chirurgicaux - Clinique Ambroise Paré

Neuilly-sur-Seine, 92200

France

CHU Bordeaux Haut-Leveque

Pessac, 33600

France

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310

France

CHU Rangueil

Toulouse, 31059

France

Evangelismos General Hospital of Athens

Athens, 106 76

Greece

Thoracic General Hospital of Athens "I Sotiria"

Athens, 115 27

Greece

University General Hospital of Heraklion

Heraklion, 711 10

Greece

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, 54642

Greece

Óbudai Egészségügyi Centrum

Budapest, 1036

Hungary

Semmelweis University

Budapest, 1083

Hungary

Clinexpert Gyöngyös

Gyöngyös, 3200

Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, 2800

Hungary

Motilal Nehru Medical College Hospital

Allahābād, 211002

India

KLES Dr. Prabhakar Kore Hospital & M.R.C

Belagavi, 590010

India

Belagavi Institute of Medical Sciences - Belagavi

Belgavi, 590019

India

Graphic Era Institute of Medical Sciences and Hospital

Dehradun, 248008

India

Mahavir Hospital & Research Centre - Hyderabad

Hyderabad, 500004

India

SR Kalla Memorial Gastro & General Hospital

Jaipur, 302001

India

Lakeshore Hospital

Kochi, 682040

India

Dr. Ram Manohar Lohia Institute of Medical Sciences

Lucknow, 226010

India

Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

Mumbai, 400008

India

Midas Multispeciality Hospital Pvt.Ltd.

Nagpur, 440010

India

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur, 441108

India

All India Institute of Medical Sciences

New Delhi, 110029

India

Yatharth Super Speciality Hospital - Noida Extension

Noida, 201306

India

Gastrohub Hospital

Pune, 411027

India

Lifepoint Multispeciality Hospital

Pune, 411057

India

Pacific Medical College & Hospital

Udaipur, 313001

India

Assuta Ashdod Medical Center

Ashdod, 7747629

Israel

Barzilai Medical Center

Ashkelon, 7830604

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Clalit Health Services - Lev Talpiot Clinic

Jerusalem, 9362410

Israel

Meir Medical Center

Kfar Saba, 4428164

Israel

Yitzhak Shamir Medical Center

Ẕerifin, 7033001

Israel

IRCCS Policlinico San Donato

Milan, 20097

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Ospedale Di Circolo

Rho, 20017

Italy

Fondazione Policlinico Tor Vergata

Rome, 00133

Italy

Azienda Ospedaliera San Camillo Forlanini

Rome, 00152

Italy

Ospedale Isola Tiberina - Gemelli Isola

Rome, 00186

Italy

Humanitas

Rozzano, 20089

Italy

Asahikawa Medical University Hospital

Asahikawa, 078-8510

Japan

Juntendo University Hospital

Bunkyō City, 113-8431

Japan

Sai Gastroenterology/Proctology Clinic

Fujiidera, 583-0027

Japan

Fukuoka University Hospital

Fukuoka, 814-0180

Japan

National Hospital Organization Hirosaki General Medical Center

Hirosaki, 036-8545

Japan

Sameshima Hospital

Kagoshima, 892-0846

Japan

Tsujinaka Hospital - Kashiwanoha

Kashiwa, 273-0011

Japan

Kyorin University Hospital

Mitaka, 181-8611

Japan

Saiseikai Niigata Hospital

Niigata, 950-1104

Japan

Hyogo Medical University Hospital

Nishinomiya, 663-8501

Japan

Okayama University Hospital

Okayama, 700-8558

Japan

Tokitokai Tokito Clinic Coloproctology Center

Saitama, 336-0963

Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, 065-0033

Japan

The University of Osaka Hospital

Suita, 565-0871

Japan

Tokyo Yamate Medical Center

Tokyo, 169-0073

Japan

Pauls Stradins Clinical Univeristy Hospital

Riga, LV-1002

Latvia

VCA poliklīnika Aura

Riga, LV-1035

Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, LT-50161

Lithuania

Klaipeda University Hospital

Klaipėda, 92288

Lithuania

Viesoji Istaiga Klaipedos Miesto Poliklinika

Klaipėda, 93200

Lithuania

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207

Mexico

Scientia Investigacion Clinica Tj

Ciudad de Tijuana, 22105

Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, 44650

Mexico

Private Practice - Dr. Adriana Sánchez

Guadalajara, 44670

Mexico

Proactive CR México SA de CV

Irapuato, 36520

Mexico

Centro de Investigación y Gastroenterología - S.C.

Mexico City, 03330

Mexico

Centro de Investigación Clinica Chapultepec

Mexico City, 04100

Mexico

Keystone Clinical Trials

Mexico City, 06100

Mexico

Hospital Juarez de Mexico

Mexico City, 07760

Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080

Mexico

Servicios de Oncología Médica Integral - Monterrey

Monterrey, 66220

Mexico

Centro de Investigacion Clinica Chapultepec

Querétaro, 76088

Mexico

M2M Med

Chorzów, 41-500

Poland

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

Katowice, 40-600

Poland

Polimedica PTG Kielce

Kielce, 25-355

Poland

Oslomed Centrum Medyczne

Krakow, 31-228

Poland

Santa Familia PTG Lodz

Lodz, 90-302

Poland

Allmedica

Nowy Targ, 34-400

Poland

Twoja Przychodnia PCM

Poznan, 60-324

Poland

ETG Siedlce

Siedlce, 08-110

Poland

Twoja Przychodnia SCM

Szczecin, 71-434

Poland

Sonomed Sp. z o. o.

Szczecin, 71-685

Poland

H-T Centrum Medyczne Endoterapia

Tychy, 43-100

Poland

Clinical Best Solutions

Warsaw, 00-710

Poland

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

Warsaw, 04-501

Poland

ETG Zamość

Zamość, 22-400

Poland

2Ca Braga

Braga, 4710-243

Portugal

Hospital da Luz Lisboa

Lisbon, 1500-650

Portugal

Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, 1649-035

Portugal

Unidade Local de Saúde Entre o Douro e Voga

Santa Maria da Feira, 4520-211

Portugal

Pan American Center for Oncology Trials - Ciudadela

San Juan, 00909

Puerto Rico

Adult University Hospital

San Juan, 00935

Puerto Rico

MSB General Hospital

Belgrade, 11000

Serbia

Leskovac General Hospital

Leskovac, 16000

Serbia

Sremska Mitrovica Health Centre

Sremska Mitrovica, 22000

Serbia

General Hospital "Djordje Joanovic"

Zrenjanin, 23000

Serbia

Cliniq s.r.o.

Bratislava, 81109

Slovakia

Gastroentero s.r.o.

Bratislava, 821 01

Slovakia

Gastro I., s.r.o.

Prešov, 080 01

Slovakia

Vseobecna nemocnica Rimavska Sobota

Rimavská Sobota, 979 01

Slovakia

Accout Center

Šahy, 936 01

Slovakia

Iatros International

Bloemfontein, 9301

South Africa

Mediclinic Panorama

Cape Town, 7500

South Africa

Spoke Research

Cape Town, 7700

South Africa

Lenasia Clinical Trial Centre - Johannesburg

Johannesburg, 1821

South Africa

Clinresco Centres

Kempton Park, 1619

South Africa

Dong-A University Hospital

Busan, 49201

South Korea

Pusan National University Yangsan Hospital

Busan, 50612

South Korea

Kyungpook National University Hospital

Daegu, 41944

South Korea

The Catholic University of Korea, Daejeon St. Mary's Hospital

Daejeon, 34943

South Korea

Chosun University Hospital

Gwangju, 61453

South Korea

Yeungnam Univeristy Medical Center

Gyeongsan-si, 42415

South Korea

Inje University Haeundae Paik Hospital

Pusan, 48108

South Korea

Kyung Hee University Hospital

Seoul, 02447

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Kangbuk Samsung Hospital

Seoul, 03181

South Korea

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, 03312

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Wonju Severance Christian Hospital

Wŏnju, 26426

South Korea

Changhua Christian Hospital

Changhua, 50006

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

China Medical University Hospital

Taichung, 404332

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Tri-Service General Hospital

Taipei, 114

Taiwan

Bakent University, Adana Clinic & Research Ctr.

Adana, 01250

Turkey (Türkiye)

Hacettepe Universite Hastaneleri

Ankara, 06230

Turkey (Türkiye)

Antalya Egitim ve Arastırma Hastanesi

Antalya, 07100

Turkey (Türkiye)

Ege Universitesi Hastanesi

Bornova, 35100

Turkey (Türkiye)

Mustafa Kemal Universitesi

Hatay, 31030

Turkey (Türkiye)

Bezmialem Vakf Üniversitesi

Istanbul, 34093

Turkey (Türkiye)

Kocaeli University Medical Faculty Hospital

İzmit, 41380

Turkey (Türkiye)

Mersin University

Mersin, 33110

Turkey (Türkiye)

Chernivtsi Regional Clinical Hospital

Chernivtsi, 58000

Ukraine

Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

Kiev, 04050

Ukraine

Edelweiss Medics

Kyiv, 02002

Ukraine

Medical Center Ok!Clinic+

Kyiv, 02091

Ukraine

Medbud Clinic

Kyiv, 03037

Ukraine

Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"

Kyiv, 04106

Ukraine

Center of Family Medicine Plus

Kyiv, 04210

Ukraine

Progastro Clinic

Lviv, 79019

Ukraine

Transcarpathian Regional Hospital im.Andriya Novak

Uzhhorod, 88018

Ukraine

Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1"

Vinnytsia, 21029

Ukraine