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Study of LY4268989 adipic acid in adults with moderately to severely active ulcerative colitis

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What is this trial about?

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

The study focuses on adults who have Ulcerative Colitis that is moderately to severely active, meaning the colon is inflamed and causes frequent diarrhea, abdominal pain, and blood in the stool. The investigational medicine being tested is identified by the code name LY4268989, which is taken as an oral tablet. For comparison, participants may receive a matching placebo, which looks the same but does not contain the active drug.

The main goal of the trial is to find out whether LY4268989 can bring more participants into clinical remission—periods when symptoms are absent or very mild—than the placebo during the first 10 weeks and to see if the benefit continues through a longer, 52‑week maintenance phase for those who respond early. Participants will start by taking the study tablets daily for about ten weeks (the induction phase). If they show improvement, they may continue the same treatment for up to a year (the maintenance phase), with regular visits to check how they are doing.

During the study, doctors will use a scoring system called the Modified Mayo Score to decide whether a person has reached remission; this score looks at stool frequency, bleeding, endoscopic findings, and overall health. “Induction” refers to the initial treatment period aimed at quickly reducing inflammation, while “maintenance” means the ongoing treatment intended to keep the disease under control. Participants will have routine check‑ups, blood tests, and questionnaires to monitor safety and how well the medication works.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study, a baseline visit is scheduled. during this visit, medical history, current health status, and the severity of ulcerative colitis are recorded.

    Samples may be taken for laboratory tests to establish a starting point for later comparisons.

  2. Step 2

    Randomization to study medication

    Based on the study design, each participant is assigned, without knowing which, to receive either the test medication ly4268989 (also called morf‑057) or a matching placebo.

    The assignment is double‑blind, meaning neither the participant nor the study staff know which medication is being taken.

  3. Step 3

    Induction phase (first 10 weeks)

    The assigned medication is taken by mouth as a tablet.

    The protocol lists the dose as 0 mg; therefore, the exact amount is not specified in the provided information.

    The tablet is taken daily for a total of 10 weeks.

    During these 10 weeks, regular visits may occur to monitor safety and any changes in symptoms.

  4. Step 4

    Week 10 evaluation

    At the end of the 10‑week induction period, an assessment is performed to determine whether a clinical response has been achieved.

    The primary goal at this time is to see if participants reach clinical remission according to the modified mayo score.

  5. Step 5

    Maintenance phase (weeks 11–52)

    Participants who show a clinical response continue taking the same medication (test drug or placebo) for up to week 52.

    The medication is still taken orally once daily.

    The dose remains as described in the protocol (dose not specified).

    Periodic visits are scheduled to assess safety and continued effectiveness.

  6. Step 6

    Week 52 evaluation

    At week 52, a final assessment is performed to evaluate clinical remission among those who continued treatment.

    The outcome determines the long‑term efficacy of the test medication compared with placebo.

Who can join the trial?

8 criteria

  • Have a confirmed diagnosis of ulcerative colitis (UC) for at least 3 months before joining the study, and a colon scope (endoscopy) must have shown the disease.
  • Show moderately to severely active UC, which means a Modified Mayo Score (a number that measures how active the disease is) between 5 and 9, an Endoscopic Score (the view of the colon during the scope) of 2 or higher, and experience of rectal bleeding (blood in the stool) at a level of 1 or more.
  • Have ulcerative colitis that spreads beyond the rectum (the disease must affect areas of the colon above the rectum).
  • If you have had ulcerative colitis symptoms for more than 8 years, you must have had a surveillance colonoscopy (a special colon scope exam to check for polyps, abnormal cells, or cancer) within the past year, or follow local doctor guidelines.
  • Have not responded well to, stopped responding to, or could not tolerate at least one conventional medication (such as corticosteroids, which are steroids that reduce inflammation) or one advanced therapy (including drugs called biologics, Janus Kinase (JAK) inhibitors, or sphingosine‑1‑phosphate (S1P) immunomodulators). People who did not respond to the drug vedolizumab are not eligible.
  • Be able to follow the study’s birth‑control rules (use reliable contraception if required).
  • Be an adult (generally 18 years of age or older) and able to give consent.
  • Both men and women can take part in the study.

Who cannot join the trial?

6 criteria

  • Having a current diagnosis of Crohn’s disease (a different type of inflammatory bowel disease), IBD unclassified (also called indeterminate colitis, meaning the exact type of bowel inflammation is unclear), or primary sclerosing cholangitis (a disease that causes scarring of the bile ducts in the liver).
  • Having an inherited immunodeficiency syndrome (a genetic condition that weakens the immune system) or a known single‑gene (monogenic) cause of ulcerative colitis‑like inflammation in the colon.
  • Having had, or needing, bowel resection (removal of part of the intestine) or any intestinal or abdominal surgery.
  • Showing evidence of toxic megacolon (a severe, life‑threatening widening of the colon), an intra‑abdominal abscess (a pocket of infection inside the abdomen), or a stricture/stenosis (a narrowing) in the small bowel or colon that cannot be passed by a colonoscope (the tube used to look inside the colon) or that causes symptoms.
  • Having any past or current cancer of the gastrointestinal (GI) tract (the stomach, intestines, or related organs) or having lesions that are known to have a high risk of becoming GI cancer.
  • Having a diagnosis or history of any malignant (cancer) disease within the 5 years before joining the study.
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Investigated drugs

LY4268989 (MORF-057) is an experimental oral tablet that contains a compound called LY4268989 adipic acid. In this study, the medicine is being tested to see if it can help adults with moderately to severely active ulcerative colitis reach clinical remission. Researchers hope that the drug will reduce the inflammation in the colon, lessen symptoms such as bleeding and diarrhea, and improve patients’ overall health. The trial will first evaluate how well the medicine works after 10 weeks of treatment and then continue to check its safety and effectiveness over a longer period of up to one year for those who respond early.

What is already known about the treatment

LY4268989 (MORF-057) - This medication is taken by mouth as a tablet, so patients swallow it like a regular pill. It is currently an investigational drug that is being studied in clinical trials and has not yet received market approval. The drug is being tested for the treatment of adults with moderately to severely active ulcerative colitis, a condition that causes inflammation and sores in the colon. It works by blocking specific signals that trigger inflammation in the gut, and it is classified as an oral small‑molecule anti‑inflammatory therapy.

Investigated diseases

  • Ulcerative colitis, active moderate

    It is a chronic inflammation of the colon that causes ongoing diarrhea, blood in the stool, and abdominal cramping. In moderate activity, symptoms are noticeable but not disabling. The inflammation may spread gradually, causing the lining to become thicker and ulcerated. Flare‑ups can occur, followed by periods of less severe symptoms. Repeated inflammation can lead to changes in the colon lining.

  • Ulcerative colitis, active severe

    This form leads to intense diarrhea, frequent blood, urgent need to go, and significant abdominal pain. Inflammation involves larger areas of the colon and causes deeper ulceration. Symptoms are often continuous with few breaks. The disease can cause swelling and loss of tissue in the colon lining. The inflammation may persist and worsen over time.

  • Ulcerative colitis (UC)

    Ulcerative colitis is a long‑lasting disease that inflames the inner lining of the large intestine. It typically starts in the rectum and can extend upward through the colon. The condition causes recurring episodes of bowel urgency, blood, and abdominal discomfort. Inflammation may wax and wane, with periods of flare and remission. Over time, the colon lining may become thinner and develop small sores.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524404-29-00Protocol codeJ6E-MC-KWAMEstimated enrolment374 patientsSponsorEli Lilly & Co.

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