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NOT YET RECRUITING
NCT07415044
PHASE2

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1431

Start Date

2026-04

Completion Date

2031-07

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

LY4268989

Administered orally

DRUG

Placebo

Administered orally

Locations (241)

Valleywise Health Medical Center

Phoenix, Arizona, United States

One of a Kind Clinical Research Center

Scottsdale, Arizona, United States

Clinnova Research

Anaheim, California, United States

GMC Clinical Research

Folsom, California, United States

Om Research LLC

Temple City, California, United States

Om Research LLC

Victorville, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Advanced Research Institute - Denver

Denver, Colorado, United States

Rocky Mountain Gastroenterology Associates - Lakewood

Lakewood, Colorado, United States

Medical Research Center of Connecticut

Hamden, Connecticut, United States

K2 Medical Research - Daytona Beach

Daytona Beach, Florida, United States

Clinical Research of Osceola

Kissimmee, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Midwest Digestive Health & Nutrition

Des Plaines, Illinois, United States

Springfield Clinic - First

Springfield, Illinois, United States

Gastroenterology Health Partners

New Albany, Indiana, United States

Gastroenterology Health Partners

Louisville, Kentucky, United States

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

Wyoming, Michigan, United States

KAD Clinical Research

St Louis, Missouri, United States

Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive

Las Vegas, Nevada, United States

Virtua Health & Wellness Center - Moorestown

Moorestown, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Stony Brook University

Stony Brook, New York, United States

Carolina Digestive Diseases and Endoscopy Center

Greenville, North Carolina, United States

Wilmington Health, PLLC

Wilmington, North Carolina, United States

Ohio State University

Hilliard, Ohio, United States

DSI Research - Springboro

Springboro, Ohio, United States

The Oregon Clinic

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

GI Alliance - Fort Worth

Fort Worth, Texas, United States

GI Alliance - Garland

Garland, Texas, United States

Integrity Advanced Therapeutics

Houston, Texas, United States

GI Alliance: Mansfield

Mansfield, Texas, United States

Southern Star Research Institute

San Antonio, Texas, United States

GI Alliance - San Marcos

San Marcos, Texas, United States

Tyler Research Institute

Tyler, Texas, United States

Eximia Research - Norfolk

Norfolk, Virginia, United States

Principle Research Solutions

Spokane, Washington, United States

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, United States

Washington Gastroenterology - Tacoma

Tacoma, Washington, United States

Stat Research S.A.

Buenos Aires, Argentina

Mautalen Salud e Investigación

Buenos Aires, Argentina

GEDYT

Buenos Aires, Argentina

CER medical Institute

Quilmes, Argentina

INECO Neurociencias Oroño

Rosario, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Instituto Médico de Alta Complejidad San Isidro Sa

San Isidro, Argentina

C.I.C.E. 9 de Julio

San Miguel de Tucumán, Argentina

Loema Instituto de Pesquisa Clinica

Campinas, Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, Brazil

HNSG

Curitiba, Brazil

Centro de Oncologia Leonardo Da Vinci - ATO Terapias

Fortaleza, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Brazil

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

Salvador, Brazil

Irmandade da Santa Casa da Misericórdia de Santos

Santos, Brazil

BR Trials - Ensaios Clinicos e Consultoria

São Paulo, Brazil

Clínica Hepatogastro JK

São Paulo, Brazil

BRA - Clínica Médica e Terapia Assistida

Tajaí, Brazil

Health Sciences North

Greater Sudbury, Canada

London Digestive Disease Institute

London, Canada

Binzhou Medical University Hospital

Binzhou, China

Changzhou Second People's Hospital

Changzhou, China

Sichuan Provincial People's Hospital

Chengdu, China

Chongqing General Hospital

Chongqing, China

The First People's Hospital of Foshan

Foshan, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Heilongjiang Provincial Hospital

Harbin, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Huizhou Central People's Hospital

Huizhou, China

First Affiliated Hospital of Kunming Medical University

Kunming, China

Liaocheng People's Hospital

Liaocheng, China

Meihekou Central Hospital

Meihekou, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Shanghai Tenth People's Hospital

Shanghai, China

Shanghai Pudong New District Zhoupu Hospital

Shanghai, China

Yuebei People's Hospital Guangdong

Shaoguan, China

Peking University Shenzhen Hospital

Shenzhen, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Taian City Central Hospital

Taian, China

Wuhan Union Hospital

Wuhan, China

Renmin Hospital of Wuhan University

Wuhan, China

Zunyi Medical College - No.1 Affiliated Hospital

Zunyi, China

Clinica de la Costa S.A.S.

Barranquilla, Colombia

Fundacion Santa Fe de Bogota

Bogotá, Colombia

Hospital Universitario Mayor Méderi

Bogotá, Colombia

Hospital Universitario San Ignacio

Bogotá, Colombia

Hospital Pablo Tobon Uribe

Medellín, Colombia

Poliklinika MEDICO - Rijeka

Rijeka, Croatia

Klinički Bolnički Centar Split

Split, Croatia

Poliklinika Solmed

Zagreb, Croatia

Hepato-Gastroenterologie HK

Hradec Králové, Czechia

Nemocnice Pardubického kraje

Pardubice, Czechia

Clinoxus

Prague, Czechia

MEDICON

Prague, Czechia

ISCARE klinické centrum

Prague, Czechia

Nemocnice Slany

Slaný, Czechia

Nemocnice AGEL Šternberk

Sternberk, Czechia

Clinical Trials Service s.r.o.

Uherské Hradiště, Czechia

Gastro-nell

Vsetín, Czechia

Centres Médico Chirurgicaux - Clinique Ambroise Paré

Neuilly-sur-Seine, France

CHU Bordeaux Haut-Leveque

Pessac, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CHU Rangueil

Toulouse, France

Evangelismos General Hospital of Athens

Athens, Greece

Thoracic General Hospital of Athens "I Sotiria"

Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, Greece

Óbudai Egészségügyi Centrum

Budapest, Hungary

Semmelweis University

Budapest, Hungary

Clinexpert Gyöngyös

Gyöngyös, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, Hungary

Motilal Nehru Medical College Hospital

Allahabād, India

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

Belagavi, India

Belagavi Institute of Medical Sciences - Belagavi

Belgavi, India

Graphic Era Institute of Medical Sciences and Hospital

Dehradun, India

Mahavir Hospital & Research Centre - Hyderabad

Hyderabad, India

SR Kalla Memorial Gastro & General Hospital

Jaipur, India

Lakeshore Hospital

Kochi, India

Dr. Ram Manohar Lohia Institute of Medical Sciences

Lucknow, India

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

Mumbai, India

Midas Multispeciality Hospital Pvt.Ltd.

Nagpur, India

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur, India

All India Institute of Medical Sciences

New Delhi, India

Yatharth Super Speciality Hospital - Noida Extension

Noida, India

Gastrohub Hospital

Pune, India

Lifepoint Multispeciality Hospital

Pune, India

Pacific Medical College & Hospital

Udaipur, India

Assuta Ashdod Medical Center

Ashdod, Israel

Barzilai Medical Center

Ashkelon, Israel

Rambam Health Care Campus

Haifa, Israel

Clalit Health Services - Lev Talpiot Clinic

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Yitzhak Shamir Medical Center

Ẕerifin, Israel

IRCCS Policlinico San Donato

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Ospedale Di Circolo

Rho, Italy

Fondazione Policlinico Tor Vergata

Rome, Italy

Azienda Ospedaliera San Camillo Forlanini

Rome, Italy

Ospedale Isola Tiberina - Gemelli Isola

Rome, Italy

Humanitas

Rozzano, Italy

Asahikawa Medical University Hospital

Asahikawa, Japan

Juntendo University Hospital

Bunkyō City, Japan

Sai Gastroenterology/Proctology Clinic

Fujiidera, Japan

Fukuoka University Hospital

Fukuoka, Japan

National Hospital Organization Hirosaki General Medical Center

Hirosaki, Japan

Sameshima Hospital

Kagoshima, Japan

Tsujinaka Hospital - Kashiwanoha

Kashiwa, Japan

Kyorin University Hospital

Mitaka, Japan

Saiseikai Niigata Hospital

Niigata, Japan

Hyogo Medical University Hospital

Nishinomiya, Japan

Okayama University Hospital

Okayama, Japan

Tokitokai Tokito Clinic Coloproctology Center

Saitama, Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, Japan

The University of Osaka Hospital

Suita, Japan

Tokyo Yamate Medical Center

Tokyo, Japan

Liepjas reionl slimnca

Liepāja, Latvia

Pauls Stradins Clinical Univeristy Hospital

Riga, Latvia

VCA poliklīnika Aura

Riga, Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Lithuania

Klaipeda University Hospital

Klaipėda, Lithuania

Viesoji Istaiga Klaipedos Miesto Poliklinika

Klaipėda, Lithuania

Scientia Investigacion Clinica S.C.

Chihuahua City, Mexico

Scientia Investigacion Clinica Tj

Ciudad de Tijuana, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Mexico

Private Practice - Dr. Adriana Sánchez

Guadalajara, Mexico

Proactive CR México SA de CV

Irapuato, Mexico

Centro de Investigación y Gastroenterología - S.C.

Mexico City, Mexico

Centro de Investigación Clinica Chapultepec

Mexico City, Mexico

Keystone Clinical Trials

Mexico City, Mexico

Hospital Juarez de Mexico

Mexico City, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico

Servicios de Oncología Médica Integral - Monterrey

Monterrey, Mexico

Centro de Investigacion Clinica Chapultepec

Querétaro, Mexico

M2M Med

Chorzów, Poland

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

Katowice, Poland

Polimedica PTG Kielce

Kielce, Poland

Oslomed Centrum Medyczne

Krakow, Poland

Santa Familia PTG Lodz

Lodz, Poland

Twoja Przychodnia PCM

Poznan, Poland

ETG Siedlce

Siedlce, Poland

Twoja Przychodnia SCM

Szczecin, Poland

Sonomed Sp. z o. o.

Szczecin, Poland

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

Warsaw, Poland

ETG Zamość

Zamość, Poland

2Ca Braga

Braga, Portugal

Hospital da Luz Lisboa

Lisbon, Portugal

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

Lisbon, Portugal

Unidade Local de Saúde Entre o Douro e Voga

Santa Maria da Feira, Portugal

Pan American Center for Oncology Trials - Ciudadela

San Juan, Puerto Rico

Adult University Hospital

San Juan, Puerto Rico

MSB General Hospital

Belgrade, Serbia

Leskovac General Hospital

Leskovac, Serbia

Sremska Mitrovica Health Centre

Sremska Mitrovica, Serbia

General Hospital "Djordje Joanovic"

Zrenjanin, Serbia

Cliniq s.r.o.

Bratislava, Slovakia

Gastroentero s.r.o.

Bratislava, Slovakia

Gastro I., s.r.o.

Prešov, Slovakia

Vseobecna nemocnica Rimavska Sobota

Rimavská Sobota, Slovakia

Accout Center

Šahy, Slovakia

Mediclinic Panorama

Cape Town, South Africa

Spoke Research

Cape Town, South Africa

Lenasia Clinical Trial Centre - Johannesburg

Johannesburg, South Africa

Dong-A University Hospital

Busan, South Korea

Pusan National University Yangsan Hospital

Busan, South Korea

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

Daejeon, South Korea

Chosun University Hospital

Gwangju, South Korea

Yeungnam Univeristy Medical Center

Gyeongsan-si, South Korea

Inje University Haeundae Paik Hospital

Haeundae-gu, South Korea

Kyungpook National University Hospital

Junggu, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

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

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Wonju Severance Christian Hospital

Wŏnju, South Korea

Changhua Christian Hospital

Changhua County, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Bakent University, Adana Clinic & Research Ctr.

Adana, Turkey (Türkiye)

Hacettepe Universite Hastaneleri

Ankara, Turkey (Türkiye)

Antalya Egitim ve Arastırma Hastanesi

Antalya, Turkey (Türkiye)

Ege Universitesi Hastanesi

Bornova, Turkey (Türkiye)

Mustafa Kemal Universitesi

Hatay, Turkey (Türkiye)

Bezmialem Vakf Üniversitesi

Istanbul, Turkey (Türkiye)

Kocaeli University Medical Faculty Hospital

İzmit, Turkey (Türkiye)

Mersin University

Mersin, Turkey (Türkiye)

Chernivtsi Regional Clinical Hospital

Chernivtsi, Ukraine

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

Kiev, Ukraine

Edelweiss Medics

Kyiv, Ukraine

Medical Center Ok!Clinic+

Kyiv, Ukraine

Medbud Clinic

Kyiv, Ukraine

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

Kyiv, Ukraine

Center of Family Medicine Plus

Kyiv, Ukraine

Progastro Clinic

Lviv, Ukraine

Transcarpathian Regional Hospital im.Andriya Novak

Uzhhorod, Ukraine

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

Vinnytsia, Ukraine