Oral LY4268989 compared with placebo in moderate to severe ulcerative colitis
Tests whether oral LY4268989 helps adults with active ulcerative colitis, a long-term bowel disease.
Plain-language title generated from the registry record
Registry title: LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Key facts
- Where
- Milan, Rho, Rome, and Rozzano, ItalySee the 7 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active ulcerative colitis. They take LY4268989 or a placebo by mouth.
- Age
- 18 Years to 80 Years
- Sex
- All sexes can join.
- Disease stage
- Ulcerative colitis diagnosed at least 3 months before randomization, moderately to severely active (Modified Mayo Score 5 to 9), reaching beyond the rectum.
- Earlier treatment
- Not enough response, loss of response or intolerance to at least one usual medicine (including corticosteroids) or one advanced therapy (biologics, JAK inhibitors or S1P immunomodulators). Not enough response to vedolizumab means a person cannot join.
- Biomarker or test result
- Endoscopic Score of 2 or more, confirmed by a central reader, and rectal bleeding score of 1 or more.
Main reasons for not taking part
- Crohn's disease, IBD unclassified or primary sclerosing cholangitis
- Inherited immunodeficiency syndrome or known single-gene cause of UC-like colon inflammation
- Bowel resection or intestinal or intra-abdominal surgery, past or needed
- Toxic megacolon, abscess in the abdomen, or a symptomatic or impassable narrowing of the bowel
- Cancer of the gastrointestinal tract, or any cancer within 5 years before randomization
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07415044, who can take part
Where in Italy
- IRCCS Policlinico San donatoMilan, ItalyNot yet recruiting
- Ospedale San RaffaeleMilan, ItalyNot yet recruiting
- Ospedale Di CircoloRho, ItalyTaking people
- Azienda Ospedaliera San Camillo ForlaniniRome, ItalyNot yet recruiting
- Fondazione Policlinico Tor VergataRome, ItalyNot yet recruiting
- Ospedale Isola Tiberina - Gemelli IsolaRome, ItalyNot yet recruiting
- HumanitasRozzano, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07415044
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Have had or will need bowel resection or intestinal or intra-abdominal surgery; Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies; 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 a diagnosis or history of malignant disease within 5 years prior to randomization; 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.