Eli Lilly Reports Positive Data on Omvoh in Ulcerative Colitis Patients

Eli Lilly Reports Positive Data on Omvoh in Ulcerative Colitis Patients

By, Admin 28 October 2025

New data from Eli Lilly and Company revealed that patients with moderately to severely active ulcerative colitis (UC) treated with Omvoh (mirikizumab-mrkz) experienced early and sustained improvements in bowel urgency severity, frequency, and stool deferral time by Week 12, continuing through Week 28.

The findings come from LUCENT-URGE, a phase 3b, single-arm, open-label study, specifically designed to assess bowel urgency, a symptom often reported as one of the most distressing for people with UC. The results will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place October 24–29 in Phoenix.

Study Overview: Focusing on Bowel Urgency

LUCENT-URGE is the first study in inflammatory bowel disease to include novel endpoints such as bowel urgency frequency and stool deferral time, offering a more comprehensive assessment of patient experience beyond traditional clinical measures.

Key Findings from the LUCENT-URGE Study

Bowel Urgency Severity

  • Reduced by 52% at Week 28.
  • Average Urgency Numeric Rating Scale (UNRS) score decreased from 6.9 at baseline to 3.7 at Week 12 and 3.3 at Week 28.

Bowel Urgency Frequency

  • Patients reported a 55% reduction in the number of bowel urgency episodes per day.
  • Frequency dropped from 6.9 times per day at baseline to 3.1 times per day at Week 12, maintained through Week 28.

Stool Deferral Time

  • Percentage of patients able to delay bowel movement for at least 15 minutes or experience no urgency in 24 hours increased from 4.1% at baseline to 15.7% at Week 12 and 29.7% at Week 28.

These improvements indicate that Omvoh treatment may help restore control over a symptom that significantly impacts quality of life for UC patients.

Expert Commentary

“For many people with ulcerative colitis, the unpredictable and immediate need to find a restroom can be stressful and disrupt everyday activities,” said Dr. David Rubin, Professor of Medicine and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine.

“These data build on prior phase 3 and long-term results demonstrating Omvoh can reduce bowel urgency and help people regain control over a symptom that has often dictated their daily life,” he added.

Safety Profile and Clinical Consistency

Clinical, endoscopic, and histologic improvements observed in LUCENT-URGE were consistent with previously reported LUCENT phase 3 trial data.

  • The safety profile remained consistent with prior Omvoh studies.
  • Serious adverse events: reported in 5.2% of patients.
  • Discontinuations due to adverse events: 4.7%.
  • No new safety signals were identified.

Lilly’s Commitment to Advancing UC Research

“Lilly is continuing to drive novel science in the study and treatment of bowel urgency because comprehensive control of ulcerative colitis must reflect the daily realities patients face,” said Dr. Mark Genovese, Senior Vice President of Lilly Immunology Development.

“With Omvoh, we are delivering on our commitment to provide better patient outcomes,” he added.

The LUCENT-URGE findings build upon insights from Lilly’s CONFIDE study, which examined the burden of bowel urgency in daily life, and the LUCENT-3 study, which provided four-year data on long-term outcomes in bowel urgency severity.

Ongoing and Future Research

Lilly is advancing combination studies of mirikizumab to enhance induction efficacy and maintain long-term remission.
Current trials include:

  • UC with eltrekibart (NCT06598943): a monoclonal antibody targeting neutrophil-driven inflammation.
  • UC with LY4268989 (MORF-057) (NCT07186101): an oral α4β7 integrin inhibitor.
  • COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099): studies evaluating mirikizumab with incretin-based therapies in UC and Crohn’s disease patients with obesity.
  • Pediatric UC trial (NCT05784246): currently ongoing.

About Omvoh (Mirikizumab-mrkz)

Omvoh is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults.
It selectively targets the p19 subunit of IL-23, inhibiting a key pathway involved in inflammatory bowel disease pathogenesis.

Omvoh has been approved in 45 countries for adult patients with UC or Crohn’s disease.

About the LUCENT Clinical Prxogram

  • LUCENT-1 (Induction) and LUCENT-2 (Maintenance): Randomized, double-blind, placebo-controlled phase 3 trials evaluating Omvoh’s efficacy and safety in adults with UC, including both biologic-naïve and biologic-experienced patients.
  • LUCENT-URGE: Phase 3b, open-label study assessing bowel urgency outcomes over 28 weeks, with intravenous dosing (300 mg at Weeks 0, 4, and 8) followed by subcutaneous dosing (200 mg every four weeks).

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company dedicated to turning science into healing and improving lives through innovative medicines across therapeutic areas.

Omvoh and its delivery device base are trademarks of Eli Lilly and Company.

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