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Bored Studies
RecruitingPhase 2

LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

Eli Lilly and Company · NCT07186101

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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
252
US sites recruiting
37
Study start
November 10, 2025
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 the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).

Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

Being studied: LY4268989; Mirikizumab; LY4268989 Placebo

Conditions: Ulcerative Colitis

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 UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC
  • Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.
  • Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization
  • Are up-to-date on colorectal cancer surveillance per local society guidelines
  • Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:
  • Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)

NOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)

  • Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as:
  • a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12/23, or IL-23p19), except for
  • mirikizumab.
  • Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib
  • sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod

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 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 adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed

Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply

  • Have a current or recent acute, active infection

Recruiting US locations

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, AZ 85259

    Site contact: 480-301-8000

  • Clinnova Research - Anaheim

    Anaheim, CA 92805

    Site contact: Amit Bhanvadia

  • Om Research LLC

    Lancaster, CA 93534

    Site contact: 661-388-2239

  • Biopharma Informatic, LLC

    Los Angeles, CA 90035

    Site contact: 281-944-3610

  • Peak Gastroenterology Associates

    Colorado Springs, CO 80907

    Site contact: 719-310-6719

  • NeoClinical Research

    Hialeah, FL 33016

    Site contact: 305-456-9062

  • Encore Borland-Groover Clinical Research

    Jacksonville, FL 32256

    Site contact: 904-680-0871

  • Clinical Research of Osceola

    Kissimmee, FL 34741

    Site contact: 407-954-4016

  • Florida Research Institute

    Lakewood Rch, FL 34211

    Site contact: 941-727-7772

  • Alliance Medical Research

    Lighthouse PT, FL 33064

    Site contact: 954-428-2480

  • Atlantic Medical Research

    Margate, FL 33063

    Site contact: 954-850-0589

  • Digestive and Liver Center of Florida

    Orlando, FL 32825

    Site contact: 407-384-7388

  • Midtown Gastroenterology and Liver Disease

    Des Plaines, IL 60016

    Site contact: 262-925-1280

  • GI Alliance - Glenview

    Glenview, IL 60026

    Site contact: Nina Merel

  • Gi Alliance - Gurnee

    Gurnee, IL 60031

    Site contact: Jonathan A. Rosenberg

  • Gastroenterology Health Partners

    New Albany, IN 47150

    Site contact: 812-206-1702

  • Gastroenterology Health Partners

    Louisville, KY 40218

    Site contact: 502-888-1988

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: 617-732-6389

  • Clinical Research Institute of Michigan, LLC

    Clinton Township, MI 48038

    Site contact: 586-598-3329

  • GI Associates - GIA and Endoscopy Center - Flowood

    Flowood, MS 39232

    Site contact: 601-863-0395

  • Digestive Disease Medicine of Central New York

    Utica, NY 13502

    Site contact: Harvey Allen

  • Dayton Gastroenterology, LLC

    Dayton, OH 45415

    Site contact: 937-320-5050

  • University Gastroenterology - Providence - West River Street

    Providence, RI 02904

    Site contact: 401-227-8393

  • Gastroenterology Associates, P.A. of Greenville

    Greenville, SC 29607

    Site contact: 864-451-5026

  • Gastro One - Walnut Run Road

    Cordova, TN 38018

    Site contact: Ziad Younes

  • Texas Digestive Disease Consultants - Cedar Park

    Cedar Park, TX 78613

    Site contact: 512-341-0900

  • GI Alliance - Fort Worth

    Fort Worth, TX 76104

    Site contact: 817-612-5575

  • GI Alliance - Garland

    Garland, TX 75044

    Site contact: 972-265-8201

  • GI Alliance - Lubbock

    Lubbock, TX 79410

    Site contact: 806-793-3141

  • Southern Star Research Institute

    San Antonio, TX 78229

    Site contact: 210-581-2812

  • Tyler Research Institute

    Tyler, TX 75701

    Site contact: 903-630-6211

  • GI Alliance-Webster

    Webster, TX 77598

    Site contact: 281-626-7035

  • Care Access - Ogden

    Ogden, UT 84403

    Site contact: 801-614-0010

  • Clinical Research Partners, LLC

    Richmond, VA 23226

    Site contact: Kara Foster-Weiss

  • GI Alliance - Richmond

    Richmond, VA 23229

    Site contact: 804-362-0954

  • Carilion Clinic

    Roanoke, VA 24014

    Site contact: Lana Wahid

  • Washington Gastroenterology - Bellevue

    Bellevue, WA 98004

    Site contact: 425-454-4768

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 (MORF-057) Co-Administered With Mirikizumab in Adults… (NCT07186101) | Bored Studies