A Phase 2 interventional study of Placebo and MORF-057 in Inflammatory Bowel Diseases and Crohn's Disease, sponsored by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company). Recruiting at 224 sites in 28 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) (part of Eli Lilly and Company) · Phase 2, Interventional, and Treatment
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 385 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
First submitted before Morphic Therapeutic, Inc. became part of Eli Lilly and Company.
Compared within Crohn Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammatory Bowel Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
Drug: MORF-057
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
Drug: MORF-057
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Drug: Placebo · Drug: MORF-057
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
Drug: MORF-057
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
Drug: MORF-057
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Drug: Placebo · Drug: MORF-057
Matching placebo (identical appearance to MORF-057) administered orally.
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Also known as: zotemtegrast
Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)
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%
Time frame: Baseline to Week 14
Proportion of participants with clinical response at Week 14 as determined using the Crohn's Disease Activity Index (CDAI)
The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical response is defined as a reduction from baseline CDAI score by ≥100 points or a CDAI score of \<150 points.
Time frame: Baseline to Week 14
Proportion of participants with clinical remission at Week 14 as determined using the CDAI.
The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical remission is defined as a CDAI score of \<150 points.
Time frame: Baseline to Week 14
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 224 sites across 28 countries. Choose a country and city above to see the rest.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: MORF-057
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) →