Recruiting
Phase 2

LY4268989

Sponsor:

Eli Lilly and Company

Code:

NCT07415044

Conditions

Ulcerative Colitis (UC)

Ulcerative Colitis, Active Moderate

Ulcerative Colitis, Active Severe

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LY4268989

Placebo

Study Details

Brief 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.

Conditions

Ulcerative Colitis (UC)

Ulcerative Colitis, Active Moderate

Ulcerative Colitis, Active Severe

Study ID

NCT07415044

Start date

Mar 26, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1431 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY4268989 Study Dose 1

LY4268989 administered orally

experimental: LY4268989 Study Dose 2

LY4268989 administered orally

placebo comparator: Placebo Study Dose

Placebo administered orally

Interventions

LY4268989

Administered orally

Placebo

Administered orally

Primary outcome measure

  • Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [ Time Frame: Week 10 ]
  • Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Valleywise Health Medical Center

Recruiting

Phoenix, Arizona, United States, 85008

Contacts

602-344-5194

Principal Investigator:

Indu Srinivasan

Clinnova Research

Recruiting

Anaheim, California, United States, 92805

Principal Investigator:

Amit Bhanvadia

GMC Clinical Research

Recruiting

Folsom, California, United States, 95630

Principal Investigator:

Nazir Rahim

Om Research LLC

Recruiting

Temple City, California, United States, 91780

Contacts

661-388-2239

Principal Investigator:

Ken Nguyen

Om Research LLC

Recruiting

Victorville, California, United States, 92395

Contacts

661-388-2239

Principal Investigator:

Nikhil Gupta

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

719-310-6719

Principal Investigator:

Bhaktasharan Patel

Rocky Mountain Gastroenterology Associates - Lakewood

Recruiting

Lakewood, Colorado, United States, 80228

Principal Investigator:

Rajesh Jain

K2 Medical Research - Daytona Beach

Recruiting

Daytona Beach, Florida, United States, 32114

Principal Investigator:

Esteban Olivera

Clinical Research of Osceola

Recruiting

Kissimmee, Florida, United States, 34741

Contacts

407-954-4016

Principal Investigator:

Basher Atiquzzaman

Florida Research Institute

Recruiting

Lakewood Rch, Florida, United States, 34211

Contacts

941-727-7772

Principal Investigator:

Manuel Rodriguez

Treasure Valley Medical Research

Recruiting

Boise, Idaho, United States, 83706

Contacts

208-813-6505

Principal Investigator:

Neetu Talreja

Grand Teton Research Group

Recruiting

Idaho Falls, Idaho, United States, 83404

Contacts

208-528-4256

Principal Investigator:

Todd Williams

Midwest Digestive Health & Nutrition

Recruiting

Des Plaines, Illinois, United States, 60016

Contacts

312-767-3244

Principal Investigator:

Amar Naik

Springfield Clinic - First

Recruiting

Springfield, Illinois, United States, 62702

Contacts

217-528-7541

Principal Investigator:

Rajan Kochar

Gastroenterology Health Partners

Recruiting

New Albany, Indiana, United States, 47150

Contacts

812-206-1702

Principal Investigator:

Jonathan Obert

Gastroenterology Health Partners

Recruiting

Louisville, Kentucky, United States, 40218

Contacts

502-888-1988

Principal Investigator:

Michael Krease

GI Alliance - Gastro Group and Endocenter - Mandeville

Recruiting

Mandeville, Louisiana, United States, 70471

Contacts

985-323-4003

Principal Investigator:

Brandon Brousse

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

Recruiting

Wyoming, Michigan, United States, 49519

Principal Investigator:

Allan Coates

KAD Clinical Research

Recruiting

St Louis, Missouri, United States, 63123

Contacts

314-254-3168

Principal Investigator:

Adrian Di Bisceglie

Digestive Disease Specialists - Las Vegas - Crimson Canyon Drive

Recruiting

Las Vegas, Nevada, United States, 89128

Principal Investigator:

Michael Zimmerman

Saint Peter's University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Arkady Broder

Carolina Digestive Diseases and Endoscopy Center

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

252-758-8181

Principal Investigator:

Phillip Goldstein

Wilmington Health, PLLC

Recruiting

Wilmington, North Carolina, United States, 28401

Principal Investigator:

Ashok Shiani

Gastro Intestinal Research Institute of Northern Ohio, LLC

Recruiting

Westlake, Ohio, United States, 44145

Contacts

440-250-7630

Principal Investigator:

Mohamed Naem

GI Alliance - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

817-612-5575

Principal Investigator:

Kumar Gutta

GI Alliance - Garland

Recruiting

Garland, Texas, United States, 75044

Contacts

972-265-8201

Principal Investigator:

Harry Sarles

Integrity Advanced Therapeutics

Recruiting

Houston, Texas, United States, 77090

Contacts

281-453-2005

Principal Investigator:

Howard Hamat

GI Alliance: Mansfield

Recruiting

Mansfield, Texas, United States, 76063

Contacts

817-417-9664

Principal Investigator:

MOUSTAFA YOUSSEF

Southern Star Research Institute

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-581-2812

Principal Investigator:

Jeff Bullock

GI Alliance - San Marcos

Recruiting

San Marcos, Texas, United States, 78666

Contacts

512-878-1100

Principal Investigator:

Thomas Kepczyk

Tyler Research Institute

Recruiting

Tyler, Texas, United States, 75701

Contacts

903-630-6211

Principal Investigator:

George DuVall

Eximia Research-VA, LLC

Recruiting

Norfolk, Virginia, United States, 23502

Principal Investigator:

John Smith

Principle Research Solutions

Recruiting

Spokane, Washington, United States, 99202

Contacts

590-474-1107

Principal Investigator:

Harold Preiksaitis

Washington Gastroenterology - Tacoma

Recruiting

Tacoma, Washington, United States, 98405

Contacts

253-272-5127

Principal Investigator:

William Holderman

Health Sciences North

Recruiting

Greater Sudbury, Canada, P3E 5J1

Principal Investigator:

Anas Eddin

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-21.