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Evaluating MORF-057 for treating active Crohn's disease in adults

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)

Phase 2 Interventional Eli Lilly and Company · NCT06226883

This study is testing a new medication called MORF-057 to see if it can help adults with moderately to severely active Crohn's disease who haven't had enough relief from other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment385 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsvedolizumab, radiation, methotrexate
Locations215 sites (Lancaster, California and 214 other locations)
Trial IDNCT06226883 on ClinicalTrials.gov

What this trial studies

This Phase 2 study is designed to assess the efficacy and safety of two active dose regimens of MORF-057 compared to a placebo in adults suffering from moderately to severely active Crohn's disease. Participants will undergo a 14-week induction period followed by a 38-week maintenance period where all will receive open-label MORF-057. The study aims to determine how well this treatment works for individuals who have not responded adequately to previous therapies. The total treatment duration for participants who complete the study will be 52 weeks, with an option for a maintenance extension.

Who should consider this trial

Good fit: Ideal candidates are adults with moderately to severely active Crohn's disease who have experienced inadequate response or intolerance to previous treatments.

Not a fit: Patients with Crohn's disease isolated to the oral cavity, stomach, duodenum, or jejunum, or those with other forms of colitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with Crohn's disease who have not responded to existing therapies.

How similar studies have performed: Previous studies of similar integrin-targeting therapies have shown promise in treating Crohn's disease, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Has signs/symptoms of CD for at least 90 days prior to screening
* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points
* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)
* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase \[JAK\] inhibitors, applicable investigational products)

Key Exclusion Criteria:

* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
* Has had extensive bowel resection (\>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome
* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
* Has positive findings on a subjective neurological screening questionnaire
* Has a concurrent, clinically significant, serious, unstable comorbidity
* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
* Is currently participating in any other interventional study or has received any investigational therapy within 30 days
* Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
* Unable to attend study visits or comply with study procedures
* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease

Where this trial is running

Lancaster, California and 214 other locations

+165 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Inflammatory Bowel DiseasesCrohn's DiseaseCrohn's diseaseInflammatory bowel diseasea4b7Moderate-to-severeIntegrinGARNET
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.