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RecruitingPhase 2

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis

Eli Lilly and Company · NCT07415044

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
1431
US sites recruiting
39
Study start
March 26, 2026
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LY4268989; Placebo

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Valleywise Health Medical Center

    Phoenix, AZ 85008

    Site contact: 602-344-5194

  • Clinnova Research

    Anaheim, CA 92805

    Site contact: Amit Bhanvadia

  • GMC Clinical Research

    Folsom, CA 95630

    Site contact: Nazir Rahim

  • Om Research LLC

    Temple City, CA 91780

    Site contact: 661-388-2239

  • Om Research LLC

    Victorville, CA 92395

    Site contact: 661-388-2239

  • Peak Gastroenterology Associates

    Colorado Springs, CO 80907

    Site contact: 719-310-6719

  • Rocky Mountain Gastroenterology Associates - Lakewood

    Lakewood, CO 80228

    Site contact: Rajesh Jain

  • K2 Medical Research - Daytona Beach

    Daytona Beach, FL 32114

    Site contact: Esteban Olivera

  • Clinical Research of Osceola

    Kissimmee, FL 34741

    Site contact: 407-954-4016

  • Florida Research Institute

    Lakewood Rch, FL 34211

    Site contact: 941-727-7772

  • Treasure Valley Medical Research

    Boise, ID 83706

    Site contact: 208-813-6505

  • Grand Teton Research Group

    Idaho Falls, ID 83404

    Site contact: 208-528-4256

  • Midwest Digestive Health & Nutrition

    Des Plaines, IL 60016

    Site contact: 312-767-3244

  • Springfield Clinic - First

    Springfield, IL 62702

    Site contact: 217-528-7541

  • Gastroenterology Health Partners

    New Albany, IN 47150

    Site contact: 812-206-1702

  • Gastroenterology Health Partners

    Louisville, KY 40218

    Site contact: 502-888-1988

  • GI Alliance - Gastro Group and Endocenter - Mandeville

    Mandeville, LA 70471

    Site contact: 985-323-4003

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

    Wyoming, MI 49519

    Site contact: Allan Coates

  • KAD Clinical Research

    St Louis, MO 63123

    Site contact: 314-254-3168

  • Specialists in Gastroenterology

    St Louis, MO 63141

    Site contact: Benjamin Root

  • Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive

    Las Vegas, NV 89128

    Site contact: Michael Zimmerman

  • Saint Peter's University Hospital

    New Brunswick, NJ 08901

    Site contact: Arkady Broder

  • Carolina Digestive Diseases and Endoscopy Center

    Greenville, NC 27834

    Site contact: 252-758-8181

  • Wilmington Health, PLLC

    Wilmington, NC 28401

    Site contact: Ashok Shiani

  • DSI Research, LLC d/b/a ObjectiveHealth Clinical Research - Springboro

    Springboro, OH 45066

    Site contact: Anjali Morey

  • Gastro Intestinal Research Institute of Northern Ohio, LLC

    Westlake, OH 44145

    Site contact: 440-250-7630

  • The Oregon Clinic

    Portland, OR 97220

    Site contact: Phillip Kiyasu

  • Sanford USD Medical Center

    Sioux Falls, SD 57105

    Site contact: Ahmed Kurdi

  • Skyline Gastroenterology of West Tennessee

    Jackson, TN 38301

    Site contact: 731-280-0157

  • GI Alliance - Fort Worth

    Fort Worth, TX 76104

    Site contact: 817-612-5575

  • GI Alliance - Garland

    Garland, TX 75044

    Site contact: 972-265-8201

  • Integrity Advanced Therapeutics

    Houston, TX 77090

    Site contact: 281-453-2005

  • GI Alliance: Mansfield

    Mansfield, TX 76063

    Site contact: 817-417-9664

  • Southern Star Research Institute

    San Antonio, TX 78229

    Site contact: 210-581-2812

  • GI Alliance - San Marcos

    San Marcos, TX 78666

    Site contact: 512-878-1100

  • Tyler Research Institute

    Tyler, TX 75701

    Site contact: 903-630-6211

  • Eximia Research-VA, LLC

    Norfolk, VA 23502

    Site contact: John Smith

  • Principle Research Solutions

    Spokane, WA 99202

    Site contact: 590-474-1107

  • Washington Gastroenterology - Tacoma

    Tacoma, WA 98405

    Site contact: 253-272-5127

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
LY4268989 in Adults With Moderately to Severely Active Ulcerative… (NCT07415044) | Bored Studies