Inflammatory Bowel DiseasesPhase 2EMERALD-1NCT05291689
A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
A Phase 2 study testing MORF-057 in people with Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) at 17 sites in 2 countries.
Trial summary
This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Colitis, Ulcerative
- What is being tested?
- MORF-057
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 13 Apr 2022to 19 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening
- Has evidence of UC extending at least 15 cm from the anal verge
- Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs
- Agrees to abide by the study guidelines and requirements
- Capable of giving signed informed consent
Who cannot join
- Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease
- Has positive findings on a subjective neurological screening questionnaire
- Has a concurrent, clinically significant, serious, unstable comorbidity
- Primary non-responder to vedolizumab or other integrin inhibitors
- Participation in any other interventional study or 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
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Poland12 sites
Clinical Study Site
Bydgoszcz, 85-794
Clinical Study Site
Elblag, 82-300
Clinical Study Site
Katowice, 40-748
Clinical Study Site
Lodz, 90-349
Clinical Study Site
Lodz, 90-752
Clinical Study Site
Oświęcim, 32-600
Clinical Study Site
Sopot, 81-756
Clinical Study Site
Sosnowiec, 41-209
Clinical Study Site
Staszów, 28-200
Clinical Study Site
Tychy, 43-100
Clinical Study Site
Warsaw, 00-728
Clinical Study Site
Warsaw, 02-665
United States5 sites
Clinical Study Site
Brooklyn, New York, 11235
Clinical Study Site
Freehold, New Jersey, 07728
Clinical Study Site
Lafayette, Louisiana, 70503
Clinical Study Site
New York, New York, 10075
Clinical Study Site
Tampa, Florida, 33609
About this study
Official title: A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-1)
This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC)
Read the detailed description
The main part of this Phase 2a study will consist of 3 study periods: a Screening Period, a Treatment Period and a Safety Follow-up Period. All participants who complete the open-label Treatment Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative
- Being tested
- MORF-057
- Keywords
- Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), a4b7, Moderately to severely active ulcerative colitis, Integrin
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORF-057Drug
Also called LY4268989
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
| Study group | Role | What they receive |
|---|---|---|
| MORF-057 | Experimental | Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks. Receives: Drug: MORF-057 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
Measured: From baseline to 12 weeks
Secondary outcomes (4)
Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score
The Modified Mayo Clinic Score (mMCS) is a composite of the following Mayo Clinic Score subscores: Endoscopy subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration), Stool Frequency subscore (range: 0=Normal number of stools for this participant to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed).
The total mMCS ranges from 0 to 9, with higher scores indicating more severe disease.
Measured: From baseline to 12 weeks
Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057
To determine the Maximum Plasma Concentration of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
Measured: 12 weeks
Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057
To determine the Tmax of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
Measured: 12 weeks
Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057
To determine the area under the concentration-time curve of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start13 Apr 2022
- Primary completion18 Oct 2023
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291689
- Sponsor's protocol ID
- 27506
- Other IDs
- J6E-MC-KWAL, MORF-057-201, 2024-516960-27-00, 2021-005288-31
- Acronym
- EMERALD-1
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2022
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sands BE, Schreiber S, Danese S, Kierkus J, Abhyankar B, Choi MY, Soo C, Wu Y, Sun F, Lee D, Cui D, Mangada M, Singhal P, Hussain A, Rogers BN, Peyrin-Biroulet L, Feagan BG. A Phase 2 Study of MORF-057, an Oral alpha4beta7 Integrin Inhibitor in Moderately to Severely Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2026 Feb;24(2):525-534. doi: 10.1016/j.cgh.2025.07.030. Epub 2025 Aug 6.
PubMed 40769468
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-1)
- ClinicalTrials.gov ID
- NCT05291689
- Acronym / sponsor ID
- EMERALD-1 / 27506
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative
- Keywords
- Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), a4b7, Moderately to severely active ulcerative colitis, Integrin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC)
Detailed description
The main part of this Phase 2a study will consist of 3 study periods: a Screening Period, a Treatment Period and a Safety Follow-up Period. All participants who complete the open-label Treatment Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MORF-057 | Experimental | Drug: MORF-057Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening
- Has evidence of UC extending at least 15 cm from the anal verge
- Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs
- Agrees to abide by the study guidelines and requirements
- Capable of giving signed informed consent
Key exclusion criteria (7 listed)
- Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease
- Has positive findings on a subjective neurological screening questionnaire
- Has a concurrent, clinically significant, serious, unstable comorbidity
- Primary non-responder to vedolizumab or other integrin inhibitors
- Participation in any other interventional study or received any investigational therapy within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORF-057Also: LY4268989MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. | Drug | MORF-057 |
Primary outcome
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Time frame: From baseline to 12 weeks
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
4 secondary outcomes
Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score
Time frame: From baseline to 12 weeks
Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057
Time frame: 12 weeks
Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057
Time frame: 12 weeks
Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40769468Sands BE, Schreiber S, Danese S, Kierkus J, Abhyankar B, Choi MY, Soo C, Wu Y, Sun F, Lee D, Cui D, Mangada M, Singhal P, Hussain A, Rogers BN, Peyrin-Biroulet L, Feagan BG. A Phase 2 Study of MORF-057, an Oral alpha4beta7 Integrin Inhibitor in Moderately to Severely Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2026 Feb;24(2):525-534. doi: 10.1016/j.cgh.2025.07.030. Epub 2025 Aug 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MORF-057 in people with Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Poland, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score (time frame: From baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.