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Clinical Trials in India / NCT07415044
Recruiting Phase 2

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

NCT07415044 · tracked via the Priya Life Science India tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-03-26
Last updated
2026-09-08

Condition(s) studied

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

Investigational drug(s) / intervention(s)

LY4268989Placebo

LY4268989: Administered orally

Placebo: Administered orally

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (259)

FacilityCityRegionStatus
Valleywise Health Medical Center Phoenix Arizona Recruiting
One of a Kind Clinical Research Center Scottsdale Arizona Suspended
Clinnova Research Anaheim California Recruiting
GMC Clinical Research Folsom California Recruiting
Om Research LLC Temple City California Recruiting
Om Research LLC Victorville California Recruiting
Peak Gastroenterology Associates Colorado Springs Colorado Recruiting
Advanced Research Institute - Denver Denver Colorado Suspended
Rocky Mountain Gastroenterology Associates - Lakewood Lakewood Colorado Recruiting
Medical Research Center of Connecticut Hamden Connecticut Not Yet Recruiting
K2 Medical Research - Daytona Beach Daytona Beach Florida Recruiting
Clinical Research of Osceola Kissimmee Florida Recruiting
Florida Research Institute Lakewood Rch Florida Recruiting
AdventHealth Orlando Orlando Florida Not Yet Recruiting
Treasure Valley Medical Research Boise Idaho Recruiting
Grand Teton Research Group Idaho Falls Idaho Recruiting
Northwestern University Chicago Illinois Not Yet Recruiting
Rush University Medical Center Chicago Illinois Not Yet Recruiting
Midwest Digestive Health & Nutrition Des Plaines Illinois Recruiting
Springfield Clinic - First Springfield Illinois Recruiting
Gastroenterology Health Partners New Albany Indiana Recruiting
Gastroenterology Health Partners Louisville Kentucky Recruiting
GI Alliance - Gastro Group and Endocenter - Mandeville Mandeville Louisiana Recruiting
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center Wyoming Michigan Recruiting
Mayo Clinic in Rochester, Minnesota Rochester Minnesota Not Yet Recruiting
KAD Clinical Research St Louis Missouri Recruiting
Specialists in Gastroenterology St Louis Missouri Not Yet Recruiting
Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive Las Vegas Nevada Recruiting
Virtua Health & Wellness Center - Moorestown Moorestown New Jersey Not Yet Recruiting
Saint Peter's University Hospital New Brunswick New Jersey Recruiting
Stony Brook University Stony Brook New York Not Yet Recruiting
Carolina Digestive Diseases and Endoscopy Center Greenville North Carolina Recruiting
Wilmington Health, PLLC Wilmington North Carolina Recruiting
Ohio State University Hilliard Ohio Not Yet Recruiting
DSI Research, LLC d/b/a ObjectiveHealth Clinical Research - Springboro Springboro Ohio Not Yet Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC Westlake Ohio Recruiting
The Oregon Clinic Portland Oregon Recruiting
Medical University of South Carolina Charleston South Carolina Not Yet Recruiting
Sanford USD Medical Center Sioux Falls South Dakota Not Yet Recruiting
Skyline Gastroenterology of West Tennessee Jackson Tennessee Not Yet Recruiting

+ 219 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07415044 on ClinicalTrials.gov ↗ ← All trials in India