RecruitingRecruiting
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
NCT07415044 · Eli Lilly and Company
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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
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
Study design
Enrollment target: 1431 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-03-26
Estimated completion: 2031-07
Last updated: 2026-06-04
Interventions
Drug: LY4268989Drug: Placebo
Primary outcomes
- • Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) (Week 10)
- • Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 (Week 52)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (253)
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Advanced Research Institute - DenverSuspended
Denver, Colorado, United States
Rocky Mountain Gastroenterology Associates - LakewoodRecruiting
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Hamden, Connecticut, United States
K2 Medical Research - Daytona BeachRecruiting
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Boise, Idaho, United States
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New Albany, Indiana, United States
Gastroenterology Health PartnersRecruiting
Louisville, Kentucky, United States
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Mansfield, Texas, United States
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San Antonio, Texas, United States
GI Alliance - San MarcosRecruiting
San Marcos, Texas, United States
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Tyler, Texas, United States
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Chengdu, China
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Chongqing, China
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Harbin, China
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Hefei, China
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Huizhou, China
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Kunming, China
Liaocheng People's HospitalNot Yet Recruiting
Liaocheng, China
Meihekou Central HospitalNot Yet Recruiting
Meihekou, China
The Affiliated Hospital of Qingdao UniversityNot Yet Recruiting
Qingdao, China
Shanghai Tenth People's HospitalNot Yet Recruiting
Shanghai, China
Shanghai Pudong New District Zhoupu HospitalNot Yet Recruiting
Shanghai, China
Yuebei People's Hospital GuangdongNot Yet Recruiting
Shaoguan, China
Peking University Shenzhen HospitalNot Yet Recruiting
Shenzhen, China
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Taian City Central HospitalNot Yet Recruiting
Taian, China
Wuhan Union HospitalNot Yet Recruiting
Wuhan, China
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Hospital Pablo Tobon UribeNot Yet Recruiting
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Poliklinika BorzanNot Yet Recruiting
Osijek, Croatia
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Nemocnice SlanyNot Yet Recruiting
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Pessac, France
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Pierre-Bénite, France
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Heraklion, Greece
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Tatabánya, Hungary
Motilal Nehru Medical College HospitalNot Yet Recruiting
Allahābād, India
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Kochi, India
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Haifa, Israel
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Kfar Saba, Israel
Yitzhak Shamir Medical CenterNot Yet Recruiting
Ẕerifin, Israel
IRCCS Policlinico San DonatoNot Yet Recruiting
Milan, Italy
Ospedale San RaffaeleNot Yet Recruiting
Milan, Italy
Ospedale Di CircoloNot Yet Recruiting
Rho, Italy
Fondazione Policlinico Tor VergataNot Yet Recruiting
Rome, Italy
Azienda Ospedaliera San Camillo ForlaniniNot Yet Recruiting
Rome, Italy
Ospedale Isola Tiberina - Gemelli IsolaNot Yet Recruiting
Rome, Italy
HumanitasNot Yet Recruiting
Rozzano, Italy
Asahikawa Medical University HospitalNot Yet Recruiting
Asahikawa, Japan
Juntendo University HospitalNot Yet Recruiting
Bunkyō City, Japan
Sai Gastroenterology/Proctology ClinicNot Yet Recruiting
Fujiidera, Japan
Fukuoka University HospitalNot Yet Recruiting
Fukuoka, Japan
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Sameshima HospitalNot Yet Recruiting
Kagoshima, Japan
Tsujinaka Hospital - KashiwanohaNot Yet Recruiting
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Kyorin University HospitalNot Yet Recruiting
Mitaka, Japan
Saiseikai Niigata HospitalNot Yet Recruiting
Niigata, Japan
Hyogo Medical University HospitalNot Yet Recruiting
Nishinomiya, Japan
Okayama University HospitalNot Yet Recruiting
Okayama, Japan
Tokitokai Tokito Clinic Coloproctology CenterNot Yet Recruiting
Saitama, Japan
Sapporo Higashi Tokushukai HospitalNot Yet Recruiting
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The University of Osaka HospitalNot Yet Recruiting
Suita, Japan
Tokyo Yamate Medical CenterNot Yet Recruiting
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Liepāja, Latvia
Pauls Stradins Clinical Univeristy HospitalNot Yet Recruiting
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Hospital of Lithuanian University of Health Sciences Kauno klinikosNot Yet Recruiting
Kaunas, Lithuania
Klaipeda University HospitalNot Yet Recruiting
Klaipėda, Lithuania
Viesoji Istaiga Klaipedos Miesto PoliklinikaNot Yet Recruiting
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Chihuahua City, Mexico
Scientia Investigacion Clinica TjNot Yet Recruiting
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Clinica de Investigacion en Reumatologia y Obesidad S. C.Not Yet Recruiting
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Hospital Juarez de MexicoNot Yet Recruiting
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Servicios de Oncología Médica Integral - MonterreyNot Yet Recruiting
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Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa MariaNot Yet Recruiting
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Kyung Hee University HospitalNot Yet Recruiting
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Seoul National University HospitalNot Yet Recruiting
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Kangbuk Samsung HospitalNot Yet Recruiting
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The Catholic University of Korea, Eunpyeong St. Mary's HospitalNot Yet Recruiting
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China Medical University HospitalNot Yet Recruiting
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National Taiwan University HospitalNot Yet Recruiting
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