Tests LY4268989 with mirikizumab in adults with ulcerative colitis
Tests LY4268989 added to mirikizumab in adults with active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
Key facts
- Where
- Changzhou, Chongqing, Fuzhou, Hangzhou, Kunming, Nanjing, Qingdao, Shenyang, Shijiazhuang, Taian, Wuhan, and Wuxi, ChinaSee the 12 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active ulcerative colitis. It tests LY4268989 given together with mirikizumab, compared with mirikizumab alone.
- Age
- 18 to 80 years
- Sex
- All sexes can join
- Disease stage
- Moderately to severely active ulcerative colitis, diagnosed at least 3 months before the start, with a mMS of 5 to 9, an ES of 2 or more and an RB of 1 or more
- Earlier treatment
- The person must have had an inadequate response, loss of response or intolerance to at least 1 earlier medicine, such as corticosteroids, immunomodulators, or advanced therapy (a biologic, a JAK inhibitor or an S1PR inhibitor). Mirikizumab is the exception to the biologics.
Main reasons for not taking part
- Crohn's disease, unclassified IBD or primary sclerosing cholangitis
- Bowel resection or intestinal or intra-abdominal surgery, past or needed
- Toxic megacolon, abscess in the abdomen, or bowel narrowing that is symptomatic or cannot be passed by a colonoscope
- An adenomatous polyp in healthy colon areas that has not been removed
- A current or recent acute, active infection
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07186101, who can take part
Where in China
- Changzhou Second People's HospitalChangzhou, ChinaTaking people
- Chongqing General HospitalChongqing, ChinaTaking people
- The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaTaking people
- Sir Run Run Shaw Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
- First Affiliated Hospital of Kunming Medical UniversityKunming, ChinaTaking people
- Jiangsu Province HospitalNanjing, ChinaTaking people
- The Affiliated Hospital of Qingdao UniversityQingdao, ChinaTaking people
- Shengjing Hospital Of China Medical UniversityShenyang, ChinaTaking people
- The Second Afilliated Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- Taian City Central HospitalTaian, ChinaTaking people
- Wuhan Union HospitalWuhan, ChinaTaking people
- Wuxi People's HospitalWuxi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07186101
- Record updated
- 4 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis
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.
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); 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: Have had or will need bowel resection or intestinal or intra-abdominal surgery; Have a current diagnosis of; Crohn's disease; Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or; primary sclerosing cholangitis; Have a current or recent acute, active infection; 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.