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Taking peoplePhase 2

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.

Key facts

Who runs it
Eli Lilly and Company
Where
Belgrade, Leskovac, Sremska Mitrovica, and Zrenjanin, SerbiaSee the 4 sitesAlso in 27 other countries, 254 sites
Trial code
Registry title
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Status
Recruiting
Phase
Phase 2
People taking part
1,431 people, planned
Started
26 Mar 2026
Expected to end
Jul 2031
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LY4268989
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Serbia

Also in 27 other countries, 254 sites

  • MSB General HospitalBelgrade, SerbiaContact: Dragan Tomic (principal investigator)Not yet recruiting
  • Leskovac General HospitalLeskovac, SerbiaContact: Tomislav Tasic (principal investigator)Not yet recruiting
  • Sremska Mitrovica Health CentreSremska Mitrovica, SerbiaContact: RADOVAN ZEC (principal investigator)Not yet recruiting
  • General Hospital - Djordje JoanovicZrenjanin, SerbiaContact: Tatjana Latinovic Radakovic (principal investigator)Not yet recruiting

About the trial

What the trial wants to find out

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

The study will last up to approximately 108 weeks, excluding screening.

The 3 groups in the trial

  • LY4268989 Study Dose 1Treatment being tested

    LY4268989 administered orally

    Treatment: LY4268989

  • LY4268989 Study Dose 2Treatment being tested

    LY4268989 administered orally

    Treatment: LY4268989

  • Placebo Study DosePlacebo, for comparison

    Placebo administered orally

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Oral LY4268989 compared with placebo in moderate to severe ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07415044, who can take part
Record updated
4 November 2026