Phase 2 Study of MORF-057 for Crohn's Disease

This Phase 2 study is testing a new oral medication called MORF-057 for adults with moderately to severely active Crohn's disease (CD). MORF-057 works by selectively blocking integrin α4β7, which is involved in inflammation. The study will compare MORF-057 to a placebo (an inactive pill that looks the same) to see how well it works and if it's safe. Researchers will measure how many participants show an endoscopic response (improvement seen during an endoscopy) after 14 weeks. You might be able to join if you are between 18 and 85 years old, have had Crohn's symptoms for at least 90 days, and your current treatments haven't worked well enough. The study is currently recruiting about 385 participants.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study involving about 385 participants. It will compare three different doses of MORF-057 to a placebo.
What's involved
Participants will receive either MORF-057 or placebo for 14 weeks, followed by open-label MORF-057 for 38 weeks. There is also an option to continue treatment for another 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed during the 14-week induction period, the 38-week maintenance period, and potentially a 52-week long-term extension.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06226883

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Recruiting
PHASE2Ages 18–85InterventionalTreatment
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
~385 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:PlaceboMORF-057

At a glance

Recruiting sites
163 of 225 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)
Measured over Baseline to Week 14
Inflammatory Bowel Diseases
Crohn's Disease
225 sites across 39 states
Poland26
India16
Japan15
Germany13
Canada12
Italy12
Taiwan12
Georgia8
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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
  • Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)Baseline to Week 14

    The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%