LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe

In brief

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.

Key facts

Study ID

NCT07415044

Run by

Eli Lilly and Company

People needed

1431

Starts

2026-03-26

Expected to finish

2031-07-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wilmington Health, PLLC — Wilmington, North Carolina, United States (enrolling)
• Integrity Advanced Therapeutics — Houston, Texas, United States (enrolling)
• Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive — Las Vegas, Nevada, United States (enrolling)
• Carolina Digestive Diseases and Endoscopy Center — Greenville, North Carolina, United States (enrolling)
• GI Alliance - Fort Worth — Fort Worth, Texas, United States (enrolling)
• GI Alliance - Garland — Garland, Texas, United States (enrolling)
• Valleywise Health Medical Center — Phoenix, Arizona, United States (enrolling)
• KAD Clinical Research — St Louis, Missouri, United States (enrolling)
• Om Research LLC — Temple City, California, United States (enrolling)
• Saint Peter's University Hospital — New Brunswick, New Jersey, United States (enrolling)
• Om Research LLC — Victorville, California, United States (enrolling)
• Florida Research Institute — Lakewood Rch, Florida, United States (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• Clinnova Research — Anaheim, California, United States (enrolling)
• Grand Teton Research Group — Idaho Falls, Idaho, United States (enrolling)
• GMC Clinical Research — Folsom, California, United States (enrolling)
• Rocky Mountain Gastroenterology Associates - Lakewood — Lakewood, Colorado, United States (enrolling)
• Midwest Digestive Health & Nutrition — Des Plaines, Illinois, United States (enrolling)
• Springfield Clinic - First — Springfield, Illinois, United States (enrolling)
• Gastroenterology Health Partners — New Albany, Indiana, United States (enrolling)
• Gastroenterology Health Partners — Louisville, Kentucky, United States (enrolling)
• K2 Medical Research - Daytona Beach — Daytona Beach, Florida, United States (enrolling)
• Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center — Wyoming, Michigan, United States (enrolling)
• Clinical Research of Osceola — Kissimmee, Florida, United States (enrolling)
• GI Alliance: Mansfield — Mansfield, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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