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Taking people in United StatesPhase 2

Tests LY4268989 with mirikizumab in adults with ulcerative colitis

Tests LY4268989 added to mirikizumab in adults with active ulcerative colitis.

Key facts

Who runs it
Eli Lilly and Company
Where
Anaheim, Belleville, Bellevue, Boston, Cedar Park, Chicago, Clinton Township, Colorado Springs, Cordova, Dallas, Dayton, Des Plaines, Flowood, Fort Worth, Garland, Glenview, Greenville, Gurnee, Hialeah, Jacksonville, Kissimmee, Lakewood Rch, Lancaster, Lighthouse PT, Los Angeles, Louisville, Lubbock, Margate, New Albany, Ogden, Orlando, Providence, Richmond, Roanoke, San Antonio, Scottsdale, Tyler, Utica, and Webster, United StatesSee the 40 sitesAlso in 16 other countries, 107 sites
Trial code
Registry title
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
Status
Recruiting
Phase
Phase 2
People taking part
252 people, planned
Started
10 Nov 2025
Expected to end
Mar 2029
Type of study
Interventional, 2 groups
Treatments tested
  • LY4268989
  • Mirikizumab
  • LY4268989 Placebo
Record updated
4 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in United States

Also in 16 other countries, 107 sites

  • Clinnova Research - AnaheimAnaheim, United StatesContact: Amit Bhanvadia (principal investigator)Taking people
  • Center for Gastrointestinal Health - Fairview HeightsBelleville, United StatesContact: SHAKEEL AHMED (principal investigator)Not yet recruiting
  • Washington Gastroenterology - BellevueBellevue, United StatesContact: Nicholas Procaccini (principal investigator)Taking people
  • Brigham and Women's HospitalBoston, United StatesContact: Jessica Allegretti (principal investigator)Taking people
  • Texas Digestive Disease Consultants Cedar ParkCedar Park, United StatesContact: Junaid Siddiqui (principal investigator)Taking people
  • Northwestern UniversityChicago, United StatesContact: Keith Summa (principal investigator)Not yet recruiting
  • Clinical Research Institute of Michigan, LLCClinton Township, United StatesContact: Mohanad Suede (principal investigator)Taking people
  • Peak Gastroenterology AssociatesColorado Springs, United StatesContact: Bhaktasharan Patel (principal investigator)Taking people
  • Gastro One (Walnut Run Road)Cordova, United StatesContact: Ziad Younes (principal investigator)Taking people
  • GI Alliance - Dallas - Gaston AvenueDallas, United StatesContact: Ben Kahn (principal investigator)Not yet recruiting
  • Dayton Gastroenterology, LLCDayton, United StatesContact: Drew Triplett (principal investigator)Taking people
  • Midtown Gastroenterology and Liver DiseaseDes Plaines, United StatesContact: John Agaiby (principal investigator)Taking people
  • GI Associates - GIA and Endoscopy Center - FlowoodFlowood, United StatesContact: Ralph Vance (principal investigator)Taking people
  • GI Alliance - Fort WorthFort Worth, United StatesContact: Kumar Gutta (principal investigator)Taking people
  • GI Alliance - GarlandGarland, United StatesContact: Harry Sarles (principal investigator)Taking people
  • GI Alliance GlenviewGlenview, United StatesContact: Nina Merel (principal investigator)Taking people
  • Gastroenterology Associates, P.A. of GreenvilleGreenville, United StatesContact: Matthew Barnes (principal investigator)Taking people
  • GI Alliance GurneeGurnee, United StatesContact: Jonathan A. Rosenberg (principal investigator)Taking people
  • NeoClinical ResearchHialeah, United StatesContact: Isaac Bassan (principal investigator)Taking people
  • ENCORE Borland Groover Clinical ResearchJacksonville, United StatesContact: Kyle Etzkorn (principal investigator)Taking people
  • Clinical Research of OsceolaKissimmee, United StatesContact: Basher Atiquzzaman (principal investigator)Taking people
  • Florida Research InstituteLakewood Rch, United StatesContact: Manuel Rodriguez (principal investigator)Taking people
  • Om Research LLCLancaster, United StatesContact: Jatinder Pruthi (principal investigator)Taking people
  • Alliance Medical ResearchLighthouse PT, United StatesContact: Vipin Gupta (principal investigator)Taking people
  • Biopharma Informatic LLCLos Angeles, United StatesContact: Morris Silver, MD (principal investigator)Taking people
  • Gastroenterology Health PartnersLouisville, United StatesContact: Michael Krease (principal investigator)Taking people
  • GI Alliance - LubbockLubbock, United StatesContact: Adam Hughston (principal investigator)Taking people
  • Atlantic Medical ResearchMargate, United StatesContact: Peter Gach (principal investigator)Taking people
  • Gastroenterology Health PartnersNew Albany, United StatesContact: Robert Luckett (principal investigator)Taking people
  • Care Access - OgdenOgden, United StatesContact: Chad Gonzales (principal investigator)Taking people
  • Digestive and Liver Center of FloridaOrlando, United StatesContact: Harinath Sheela (principal investigator)Taking people
  • University Gastroenterology - Providence - West River StreetProvidence, United StatesContact: Jason Ferreira (principal investigator)Taking people
  • Clinical Research Partners, LLCRichmond, United StatesContact: Kara Foster-Weiss (principal investigator)Taking people
  • GI Alliance RichmondRichmond, United StatesContact: Omer Khalid (principal investigator)Taking people
  • Carilion ClinicRoanoke, United StatesContact: Lana Wahid (principal investigator)Taking people
  • Southern Star Research InstituteSan Antonio, United StatesContact: Jeff Bullock (principal investigator)Taking people
  • Mayo Clinic in Arizona - ScottsdaleScottsdale, United StatesContact: Manreet Kaur (principal investigator)Taking people
  • Tyler Research InstituteTyler, United StatesContact: George DuVall (principal investigator)Taking people
  • Digestive Disease Medicine Of Central New YorkUtica, United StatesContact: Harvey Allen (principal investigator)Taking people
  • GI Alliance WebsterWebster, United StatesContact: Ravi Mani (principal investigator)Taking people

About the trial

What the trial wants to find out

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

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

The 2 groups in the trial

  • LY4268989 + MirikizumabTreatment being tested

    LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2.

    Treatment: LY4268989 and Mirikizumab

  • Mirikizumab + LY4268989 PlaceboTreatment being tested

    Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.

    Treatment: Mirikizumab and LY4268989 Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests LY4268989 with mirikizumab in adults with ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07186101, who can take part
Record updated
4 November 2026