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Clinical Trials in India / NCT07186101
Recruiting Phase 2

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

NCT07186101 · tracked via the Priya Life Science India tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2025-11-10
Last updated
2026-09-08

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

LY4268989MirikizumabLY4268989 Placebo

LY4268989: Administered PO

Mirikizumab: Administered IV then SC

LY4268989 Placebo: Administered PO

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (147)

FacilityCityRegionStatus
Mayo Clinic in Arizona - Scottsdale Scottsdale Arizona Recruiting
Clinnova Research - Anaheim Anaheim California Recruiting
Om Research LLC Lancaster California Recruiting
Biopharma Informatic, LLC Los Angeles California Recruiting
Peak Gastroenterology Associates Colorado Springs Colorado Recruiting
NeoClinical Research Hialeah Florida Recruiting
Encore Borland-Groover Clinical Research Jacksonville Florida Recruiting
Clinical Research of Osceola Kissimmee Florida Recruiting
Florida Research Institute Lakewood Rch Florida Recruiting
Alliance Medical Research Lighthouse PT Florida Recruiting
Atlantic Medical Research Margate Florida Recruiting
Digestive and Liver Center of Florida Orlando Florida Recruiting
Center for Gastrointestinal Health - Fairview Heights Belleville Illinois Not Yet Recruiting
Northwestern University Chicago Illinois Not Yet Recruiting
Midtown Gastroenterology and Liver Disease Des Plaines Illinois Recruiting
GI Alliance - Glenview Glenview Illinois Recruiting
Gi Alliance - Gurnee Gurnee Illinois Recruiting
Gastroenterology Health Partners New Albany Indiana Recruiting
Gastroenterology Health Partners Louisville Kentucky Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Clinical Research Institute of Michigan, LLC Clinton Township Michigan Recruiting
GI Associates - GIA and Endoscopy Center - Flowood Flowood Mississippi Recruiting
Digestive Disease Medicine of Central New York Utica New York Recruiting
Dayton Gastroenterology, LLC Dayton Ohio Recruiting
University Gastroenterology - Providence - West River Street Providence Rhode Island Recruiting
Gastroenterology Associates, P.A. of Greenville Greenville South Carolina Recruiting
Gastro One - Walnut Run Road Cordova Tennessee Recruiting
Texas Digestive Disease Consultants - Cedar Park Cedar Park Texas Recruiting
GI Alliance - Dallas - Gaston Avenue Dallas Texas Not Yet Recruiting
GI Alliance - Fort Worth Fort Worth Texas Recruiting
GI Alliance - Garland Garland Texas Recruiting
GI Alliance - Lubbock Lubbock Texas Recruiting
Southern Star Research Institute San Antonio Texas Recruiting
Tyler Research Institute Tyler Texas Recruiting
GI Alliance-Webster Webster Texas Recruiting
Care Access - Ogden Ogden Utah Recruiting
Clinical Research Partners, LLC Richmond Virginia Recruiting
GI Alliance - Richmond Richmond Virginia Recruiting
Carilion Clinic Roanoke Virginia Recruiting
Washington Gastroenterology - Bellevue Bellevue Washington Recruiting

+ 107 more sites — see the full list on the official registry below.

On this site

📄 Omvoh (mirikizumab) drug profile →

More Eli Lilly and Company trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07186101 on ClinicalTrials.gov ↗ ← All trials in India