NCT06226883 · Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
(GARNET)
What this study is about
This is a Phase 2, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, conducted at multiple hospitals study to evaluate the effectiveness and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
View original scientific description
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
Interventions
DRUG
Placebo
Matching placebo (identical appearance to MORF-057) administered orally.
DRUG
MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Primary outcome measures
Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)
Time frame: 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%
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Has signs/symptoms of CD for at least 3 months 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)
- Agrees to abide by the study guidelines and requirements
- Capable of giving signed informed consent 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,
Where
- Lancaster, California
- San Diego, California
- Colorado Springs, Colorado
- Kissimmee, Florida
- Miami, Florida
- Orlando, Florida
- Palmetto Bay, Florida
- Atlanta, Georgia
- Houma, Louisiana
- Bridgeton, Missouri
- North Las Vegas, Nevada
- Fayetteville, North Carolina
And 12 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations