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Study of LY4268989 and Mirikizumab for Ulcerative Colitis

This study is testing a new drug, LY4268989, along with an existing treatment, mirikizumab, for adults with moderately to severely active ulcerative colitis (UC). UC is a chronic inflammatory bowel disease. Researchers want to see how well LY4268989, which works as a kinase inhibitor (a type of drug that blocks certain enzymes), works with mirikizumab compared to mirikizumab alone. To join, you must be between 18 and 80 years old, have a confirmed UC diagnosis for at least 3 months, and have moderately to severely active UC. The main goal is to see what percentage of participants achieve clinical remission (a significant reduction in symptoms) after 12 weeks. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 252 adult participants. It compares LY4268989 plus mirikizumab to a placebo (an inactive substance) plus mirikizumab.
What's involved
Your participation in this study would last about 118 weeks, including 104 weeks of treatment, and could involve up to 21 visits.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07186101

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Eli Lilly and Company
~252 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:LY4268989MirikizumabLY4268989 Placebo

At a glance

Recruiting sites
129 of 147 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
Measured over Week 12

Conditions

Ulcerative Colitis

Explore related trials

Ulcerative Colitis

Where it's being run

147 sites across 35 states
Brazil14
China12
Mexico12
Poland9
Turkey (Türkiye)9
Texas8
India8
Florida7

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Eligibility criteria

Inclusion

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)
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

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
Have a current or recent acute, active infection

What this trial measures

  • Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)Week 12

    The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES). Clinical remission (mMS) is defined as: * SF subscore = 0 or 1 and no greater than baseline * RB subscore = 0 * Centrally read ES = 0 or 1; score of 1 modified to exclude friability