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Study of ly4395089 and mirikizumab in adults with moderately to severely active Crohn’s disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial involves adults with moderately to severely active Ulcerative Colitis or Crohn’s Disease, chronic conditions that cause inflammation of the colon or the small intestine. The study is testing a combination of an oral tablet called LY4395089 taken together with an injectable medication called mirikizumab, compared with the injectable medication alone. Mirikizumab is given as a solution for injection under the skin or into a vein.

The aim is to see whether the combination improves the lining of the intestine better than the injectable medication alone over a 12‑week period. Participants will receive the assigned medication(s) at regular intervals and will have routine visits where doctors may use a thin camera (a endoscopic exam) to look at the intestine and check for improvement. The study will last about three months, after which the results will be evaluated.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining the study, initial medical examinations are performed to record the current condition of the intestine.

    Samples of blood and stool may be collected, and a baseline endoscopic examination is done to view the intestinal lining.

  2. Step 2

    First dose of <b>mirikizumab</b> (intravenous)

    A single infusion of mirikizumab at a dose of 900 mg is given through a vein (intravenous).

    The infusion takes place in a clinical setting and is monitored by study staff.

  3. Step 3

    Start oral <b>ly4395089</b> tablet

    The patient begins taking the oral tablet containing ly4395089 as instructed by the study protocol.

    The exact amount of tablet is defined by the study, but it is taken by mouth.

  4. Step 4

    Subsequent <b>mirikizumab</b> (subcutaneous) injections

    After the initial infusion, the patient receives injections of mirikizumab at a dose of 300 mg under the skin (subcutaneous).

    These injections are administered according to the study schedule, typically every four weeks, for a total period of 12 weeks.

  5. Step 5

    Regular follow‑up visits

    The patient attends clinic visits at intervals defined by the study to check safety, record any side effects, and ensure proper dosing.

    Blood tests and other assessments may be performed at each visit.

  6. Step 6

    Week 12 endoscopic evaluation

    At the end of the 12‑week treatment period, an endoscopic examination (endoscopic) is performed to view the intestinal lining.

    The results are used to determine whether a response to the treatment has been achieved.

  7. Step 7

    Study completion

    After the week‑12 assessment, the patient completes the study protocol.

    Final data are recorded, and any further care is arranged by the treating physician.

Who can join the trial?

7 criteria

  • You are an adult (18 years or older) man or woman.
  • You have been diagnosed with Ulcerative Colitis or Crohn’s Disease for at least three months, confirmed by doctors using a camera exam of the intestine (endoscopy) and a tissue test (histopathology).
  • Your disease must be moderately to severely active:
    • For Ulcerative Colitis: a modified Mayo score between 5 and 9, an Endoscopic Subscore of 2 or higher, and a rectal bleeding score of at least 1, based on a colonoscopy done within the last 21 days.
    • For Crohn’s Disease: a Crohn’s Disease Activity Index (CDAI) score between 220 and 450, and a Simple Endoscopic Score for Crohn’s Disease (SES‑CD) of 6 or more if the disease involves both the colon and ileum, or 4 or more if only the ileum is involved, based on a colonoscopy done within the last 21 days.
    • You must have shown an inadequate response, loss of response, or intolerance to at least one standard treatment such as corticosteroids (steroid medicines), immunomodulators (drugs that modify the immune system), or an advanced therapy (biologic or other newer medicines) for your condition.
    • Your recent laboratory test results must be within the ranges required by the study.
    • If you are taking diabetes medicines called GLP‑1 receptor agonists (or similar combinations), you can still join as long as the dose has been stable at the time of screening.

Who cannot join the trial?

12 criteria

  • You cannot take part if you have an unclassified form of inflammatory bowel disease (IBD) or a liver condition called primary sclerosing cholangitis. If you have ulcerative colitis, you also must not have Crohn’s disease, and if you have Crohn’s disease, you must not have ulcerative colitis.
  • You cannot take part if you have any other bone disease that changes how your bones grow or repair themselves.
  • You cannot take part if, in the last 180 days, you have had a heart attack, a stroke, been hospitalized for unstable chest pain, been hospitalized because of severe heart failure, or had a heart‑blood‑vessel procedure such as coronary revascularization.
  • You cannot take part if you are taking, or will need to take, any medication that the study rules say is not allowed.
  • You cannot take part if you have already had, or will need, surgery that removes part of the bowel or any other abdominal surgery listed in the study plan.
  • You cannot take part if you have complications of ulcerative colitis or Crohn’s disease such as a narrowed intestine (called a stricture or stenosis) or a condition called short bowel syndrome, where a large part of the intestine is missing.
  • You cannot take part if you have a serious illness that is not well‑controlled and that the doctor thinks could put your safety at risk or make it hard to understand the study results.
  • You cannot take part if you have already tried more than five advanced medicines for ulcerative colitis or Crohn’s disease that work in different ways and they did not work for you.
  • You cannot take part if a medicine that blocks a protein called interleukin‑23 (anti‑IL‑23p19 antibody) did not work for you.
  • You cannot take part if you are using, or will need to use, any other prohibited medicines specifically for ulcerative colitis or Crohn’s disease as listed in the study plan.
  • You must also meet all other exclusion rules from the main IIBD study protocol, except those that only apply to ulcerative colitis.
  • You cannot take part if you have any liver disease (also called a hepatic disease).
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Investigated drugs

Mirikizumab is a medicine given by injection, either into a vein or under the skin. It is a specially designed protein that calms the immune system, helping to reduce swelling and sores in the intestines of people with Crohn’s disease or ulcerative colitis. In this study, participants receive mirikizumab alone or together with another drug, and researchers check how well it improves the condition after 12 weeks.

LY4395089 is an experimental pill taken by mouth. It is being tested to see if it can help control the inflammation in the intestines of people with Crohn’s disease. In the trial, this tablet is given together with mirikizumab to see if the two medicines work better together than mirikizumab by itself.

The combination therapy of mirikizumab plus LY4395089 means participants take the oral tablet while also receiving the injection. The study aims to find out whether using both medicines at the same time provides a stronger improvement in gut healing compared with using the injection alone.

What is already known about the treatment

  • Mirikizumab

    Mirikizumab is given as a sterile liquid that can be injected into a vein (intravenous) or under the skin (subcutaneous) in doses of 900 mg or 300 mg respectively. It is an approved medicine for ulcerative colitis and is also being studied for Crohn’s disease. The drug works by attaching to a protein called interleukin‑23, which stops this protein from causing inflammation in the gut. It belongs to the class of humanized monoclonal antibodies that act as IL‑23 inhibitors, a type of immunomodulating therapy.

  • LY4395089

    LY4395089 is taken as an oral tablet, though no specific dose is listed in the study. It is an experimental drug that has not yet been approved and is currently being tested in clinical trials for Crohn’s disease. The medication is designed to lower gut inflammation by blocking certain immune signals that drive the disease. It is classified as a small‑molecule oral immunomodulator under investigation.

Investigated diseases

  • Ulcerative colitis

    A chronic condition that causes inflammation of the lining of the large intestine, beginning in the rectum and possibly spreading throughout the colon. It leads to periods of worsening symptoms such as frequent, bloody diarrhea and urgency, followed by times of relative calm. Over time, the inflammation can create ulcers and thicken the colon wall, which may affect how the bowel works. The disease typically follows a pattern of flare‑ups and remission.

  • Crohn disease

    A long‑lasting disorder that produces inflammation in any part of the digestive tract, most often the end of the small intestine and the start of the colon. The inflammation can extend deep into the bowel wall, causing abdominal pain, diarrhea, and narrowing of the intestine. The condition often appears in patches, with inflamed sections separated by healthy tissue. Repeated inflammation may lead to scar tissue and narrowing, and the disease usually alternates between active flare‑ups and quieter phases.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524112-11-00Protocol codeJ6Z-MC-CD01Estimated enrolment70 patientsSponsorEli Lilly & Co.

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