A Phase 2 interventional study of LY4268989 and Mirikizumab in Ulcerative Colitis, sponsored by Eli Lilly and Company. Recruiting at 147 sites in 17 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 252 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Have a current diagnosis of
Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2.
Drug: LY4268989 · Drug: Mirikizumab
Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.
Drug: Mirikizumab · Drug: LY4268989 Placebo
Administered PO
Also known as: MORF-057, zotemtegrast
Administered IV then SC
Also known as: LY3074828
Administered PO
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
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
Time frame: Week 12
Percentage of Participants Who Achieve Clinical Response with mMS
Time frame: Week 12
Percentage of Participants Who Achieve Endoscopic Improvement
Time frame: Week 12
Percentage of Participants Who Achieve Symptomatic Remission
Time frame: Week 12
Percentage of Participants Who Achieve Clinical Remission with mMS
Time frame: Week 24
Percentage of Participants Who Achieve Clinical Response with mMS
Time frame: Week 24
Percentage of Participants Who Achieve Clinical Remission with mMS
Time frame: Week 48
Percentage of Participants Who Achieve Clinical Response with mMS
Time frame: Week 48
Percentage of Participants Who Achieve Clinical Remission with mMS + Physician's Global Assessment (PGA)
Time frame: Week 48
Percentage of Participants Who Achieve Clinical Response with mMS + PGA
Time frame: Week 48
Not enrolling at this site — choose another above.
Showing the first 100 of 147 sites across 17 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Nov 2025 (actual). Primary completion is estimated for May 2027, 18 months after the start.
Of 109 industry-sponsored phase 2 interventional studies under Colitis, Ulcerative, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 35. This study's planned 18 months is below that.
Counting every sponsor, half of 153 studies reached it within 28 months; a quarter within 22 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Zotemtegrast