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LY4268989 for Moderately to Severely Active Ulcerative Colitis

This study is testing an oral medication called LY4268989 in adults with moderately to severely active ulcerative colitis (UC). Researchers want to see if LY4268989 is safe and effective compared to a placebo (an inactive pill). You might be able to join if you are between 18 and 80 years old, have had UC for at least 3 months, and your UC is active and extends beyond your rectum. The study will measure success by looking at the percentage of participants who achieve clinical remission (a significant reduction in UC symptoms) at 10 weeks and again at 52 weeks. The current status of this study is unclear, and it aims to enroll about 1431 participants.

Study design
This is an interventional study comparing LY4268989 to a placebo in approximately 1431 adult participants.
What's involved
The study will last up to approximately 108 weeks, excluding screening.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at Week 10 and Week 52.

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NCT07415044

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Eli Lilly and Company
~1,431 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:LY4268989Placebo

At a glance

Recruiting sites
124 of 259 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
Measured over Week 10
+1 more outcome measured

Conditions

Ulcerative Colitis (UC)
Ulcerative Colitis, Active Moderate
Ulcerative Colitis, Active Severe

Explore related trials

Ulcerative Colitis

Where it's being run

259 sites across 52 states
China22
India17
Japan15
Poland14
South Korea14
Mexico12
Brazil10
Ukraine10

Study leadership

  • Call 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

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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

What this trial measures

  • 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 10Week 52