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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT07186101

Run by

Eli Lilly and Company

People needed

252

Starts

2025-11-10

Expected to finish

2029-03-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinnova Research - Anaheim — Anaheim, California, United States (enrolling)
• Gastroenterology Associates, P.A. of Greenville — Greenville, South Carolina, United States (enrolling)
• Biopharma Informatic, LLC — Los Angeles, California, United States (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• Om Research LLC — Lancaster, California, United States (enrolling)
• Mayo Clinic in Arizona - Scottsdale — Scottsdale, Arizona, United States (enrolling)
• Clinical Research of Osceola — Kissimmee, Florida, United States (enrolling)
• Florida Research Institute — Lakewood Rch, Florida, United States (enrolling)
• Alliance Medical Research — Lighthouse PT, Florida, United States (enrolling)
• Atlantic Medical Research — Margate, Florida, United States (enrolling)
• Digestive and Liver Center of Florida — Orlando, Florida, United States (enrolling)
• NeoClinical Research — Hialeah, Florida, United States (enrolling)
• Encore Borland-Groover Clinical Research — Jacksonville, Florida, United States (enrolling)
• Midtown Gastroenterology and Liver Disease — Des Plaines, Illinois, United States (enrolling)
• GI Alliance - Glenview — Glenview, Illinois, United States (enrolling)
• Gi Alliance - Gurnee — Gurnee, Illinois, United States (enrolling)
• Gastroenterology Health Partners — New Albany, Indiana, United States (enrolling)
• Gastroenterology Health Partners — Louisville, Kentucky, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Clinical Research Institute of Michigan, LLC — Clinton Township, Michigan, United States (enrolling)
• GI Associates - GIA and Endoscopy Center - Flowood — Flowood, Mississippi, United States (enrolling)
• Digestive Disease Medicine of Central New York — Utica, New York, United States (enrolling)
• Dayton Gastroenterology, LLC — Dayton, Ohio, United States (enrolling)
• University Gastroenterology - Providence - West River Street — Providence, Rhode Island, United States (enrolling)
• Gastro One - Walnut Run Road — Cordova, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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