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Taking people in United StatesPhase 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
Anaheim, Boise, Charleston, Chicago, Colorado Springs, Daytona Beach, Denver, Des Plaines, Folsom, Fort Worth, Garland, Greenville, Hamden, Hilliard, Houston, Idaho Falls, Jackson, Kissimmee, Lakewood, Lakewood Rch, Las Vegas, Louisville, Mandeville, Mansfield, Moorestown, New Albany, New Brunswick, Norfolk, Orlando, Phoenix, Portland, Rochester, San Antonio, San Marcos, Scottsdale, Seattle, Sioux Falls, Spokane, Springboro, Springfield, St Louis, Stony Brook, Tacoma, Temple City, Tyler, Victorville, Westlake, Wilmington, and Wyoming, United StatesSee the 52 sitesAlso in 27 other countries, 206 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 United States

Also in 27 other countries, 206 sites

  • Clinnova ResearchAnaheim, United StatesContact: Amit Bhanvadia (principal investigator)Taking people
  • Treasure Valley Medical ResearchBoise, United StatesContact: Neetu Talreja (principal investigator)Taking people
  • Medical University of South CarolinaCharleston, United StatesContact: Erin Forster (principal investigator)Not yet recruiting
  • Northwestern UniversityChicago, United StatesContact: Keith Summa (principal investigator)Not yet recruiting
  • Rush University Medical CenterChicago, United StatesContact: Atsushi Sakuraba (principal investigator)Not yet recruiting
  • Peak Gastroenterology AssociatesColorado Springs, United StatesContact: Bhaktasharan Patel (principal investigator)Taking people
  • K2 Medical Research - Daytona BeachDaytona Beach, United StatesContact: Esteban Olivera (principal investigator)Taking people
  • Advanced Research Institute - DenverDenver, United StatesNo longer taking part
  • Midwest Digestive Health & NutritionDes Plaines, United StatesContact: Amar Naik (principal investigator)Taking people
  • GMC Clinical ResearchFolsom, United StatesContact: Nazir Rahim (principal investigator)Taking people
  • GI Alliance - Fort WorthFort Worth, United StatesContact: Kumar Gutta (principal investigator)Taking people
  • GI Alliance - GarlandGarland, United StatesContact: Harry Sarles (principal investigator)Taking people
  • Carolina Digestive Diseases and Endoscopy CenterGreenville, United StatesContact: Phillip Goldstein (principal investigator)Taking people
  • Medical Research Center of ConnecticutHamden, United StatesContact: Paul Feuerstadt (principal investigator)Not yet recruiting
  • Ohio State UniversityHilliard, United StatesContact: Jacob Skeans (principal investigator)Not yet recruiting
  • Integrity Advanced TherapeuticsHouston, United StatesContact: Howard Hamat (principal investigator)Taking people
  • Grand Teton Research GroupIdaho Falls, United StatesContact: Todd Williams (principal investigator)Taking people
  • Skyline Gastroenterology of West TennesseeJackson, United StatesContact: Brittain Little (principal investigator)Taking people
  • Clinical Research of OsceolaKissimmee, United StatesContact: Basher Atiquzzaman (principal investigator)Taking people
  • Rocky Mountain Gastroenterology Associates - LakewoodLakewood, United StatesContact: Rajesh Jain (principal investigator)Taking people
  • Florida Research InstituteLakewood Rch, United StatesContact: Manuel Rodriguez (principal investigator)Taking people
  • Digestive Disease Specialists - Las Vegas - Crimson Canyon DriveLas Vegas, United StatesContact: Michael Zimmerman (principal investigator)Taking people
  • Gastroenterology Health PartnersLouisville, United StatesContact: Michael Krease (principal investigator)Taking people
  • GI Alliance - Gastro Group and Endocenter - MandevilleMandeville, United StatesContact: Brandon Brousse (principal investigator)Taking people
  • GI Alliance - MansfieldMansfield, United StatesContact: MOUSTAFA YOUSSEF (principal investigator)Taking people
  • Virtua Health & Wellness Center - MoorestownMoorestown, United StatesContact: Sanket Patel (principal investigator)Not yet recruiting
  • Gastroenterology Health PartnersNew Albany, United StatesContact: Jonathan Obert (principal investigator)Taking people
  • Saint Peter's University HospitalNew Brunswick, United StatesContact: Arkady Broder (principal investigator)Taking people
  • Eximia Research-VA, LLCNorfolk, United StatesContact: John Smith (principal investigator)Taking people
  • AdventHealth OrlandoOrlando, United StatesContact: Jennifer Seminerio Diehl (principal investigator)Not yet recruiting
  • Valleywise Health Medical CenterPhoenix, United StatesContact: Indu Srinivasan (principal investigator)Taking people
  • The Oregon ClinicPortland, United StatesContact: Phillip Kiyasu (principal investigator)Taking people
  • Mayo Clinic in Rochester, MinnesotaRochester, United StatesContact: Amanda Johnson (principal investigator)Not yet recruiting
  • Southern Star Research InstituteSan Antonio, United StatesContact: Jeff Bullock (principal investigator)Taking people
  • GI Alliance - San MarcosSan Marcos, United StatesContact: Thomas Kepczyk (principal investigator)Taking people
  • One of a Kind Clinical Research CenterScottsdale, United StatesContact: Florin Gaidici (principal investigator)Taking people
  • Swedish Medical CenterSeattle, United StatesContact: Jason Harper (principal investigator)Not yet recruiting
  • Sanford USD Medical CenterSioux Falls, United StatesContact: Ahmed Kurdi (principal investigator)Taking people
  • Principle Research SolutionsSpokane, United StatesContact: Harold Preiksaitis (principal investigator)Taking people
  • Providence Sacred Heart Medical Center & Children's HospitalSpokane, United StatesContact: Eashen Liu (principal investigator)Taking people
  • DSI Research, LLC d/b/a ObjectiveHealth Clinical Research - SpringboroSpringboro, United StatesContact: Anjali Morey (principal investigator)Taking people
  • Springfield Clinic - FirstSpringfield, United StatesContact: Rajan Kochar (principal investigator)Taking people
  • KAD Clinical ResearchSt Louis, United StatesContact: Adrian Di Bisceglie (principal investigator)Taking people
  • Specialists in GastroenterologySt Louis, United StatesContact: Benjamin Root (principal investigator)Taking people
  • Stony Brook UniversityStony Brook, United StatesContact: Lasha Gogokhia (principal investigator)Not yet recruiting
  • Washington Gastroenterology - TacomaTacoma, United StatesContact: William Holderman (principal investigator)Taking people
  • Om Research LLCTemple City, United StatesContact: Ken Nguyen (principal investigator)Taking people
  • Tyler Research InstituteTyler, United StatesContact: George DuVall (principal investigator)Taking people
  • Om Research, LLCVictorville, United StatesContact: Nikhil Gupta (principal investigator)Taking people
  • Gastro Intestinal Research Institute of Northern Ohio, LLCWestlake, United StatesContact: Mohamed Naem (principal investigator)Taking people
  • Wilmington Health, PLLCWilmington, United StatesContact: Ashok Shiani (principal investigator)Taking people
  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research CenterWyoming, United StatesContact: Allan Coates (principal investigator)Taking people

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