A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC (EMERALD-2)

November 27, 2025 updated by: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

A Phase 2b, 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 Ulcerative Colitis (EMERALD-2)

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of three active dose regimens of MORF-057 plus a placebo regimen in study participants with moderately to severely active UC. After completion of the 12-week Induction Period, participants may be switched to a different active MORF-057 regimen during the Maintenance Period. Those randomized into the placebo group in the Induction Period will be switched to receive an active MORF-057 regimen during the Maintenance Period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Blacktown, Australia, 2148
        • Blacktown Hospital
      • Concord, Australia, 2139
        • Concord Repatriation General Hospital
      • Herston, Australia, QLD 4029
        • Royal Brisbane and Women's Hospital
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
      • South Brisbane, Australia, 4101
        • Mater Adult Hospital Brisbane
  • Austria
      • Linz, Austria, 4010
        • Order Hospital Linz Ltd. - Hospital of Sisters of Mercy
      • Salzburg, Austria, 5020
        • Salzburg Regional Hospital
      • Vienna, Austria, 1090
        • Medical University of Vienna
  • Bulgaria
      • Rousse, Bulgaria, 7005
        • Medical Center "Rusemed" EOOD
      • Sofia, Bulgaria, 1202
        • University Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic"
      • Sofia, Bulgaria, 2700
        • Second Multiprofile Hospital for Active Treatment - Sofia
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
  • Czechia
      • Olomouc, Czechia, 77900
        • PreventaMed, s.r.o.
      • Prague, Czechia, 140 00
        • Clinoxus s.r.o., Outpatient Clinic Budejovicka
  • Estonia
      • Pärnu, Estonia, 80010
        • LV Venter OU
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital
      • Tallinn, Estonia, 10117
        • OU Innomedica
      • Tartu, Estonia, 51014
        • University of Tartu
  • France
      • Nice, France, 06202
        • Centre Hospitalier Universitaire de Nice - Hopital l'Archet
  • Georgia
      • Tbilisi, Georgia, 0160
        • LTD Aversi Clinic
      • Tbilisi, Georgia, 0180
        • LTD The First Medical Center
      • Tbilisi, Georgia, 0114
        • Curatio, Jsc
      • Tbilisi, Georgia, 0101
        • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
      • Tbilisi, Georgia, 0159
        • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
      • Tbilisi, Georgia, 0179
        • Medical Center "CITO" Ltd.
  • Germany
      • Berlin, Germany, 14163
        • Krankenhaus Waldfriede
      • Berlin, Germany, 10117
        • Charite - University Hospital Berlin
      • Kiel, Germany, 24105
        • University Hospital Schleswig-Holstein
      • Ulm, Germany, 89081
        • University Hospital Ulm
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Medical University
      • Budapest, Hungary, H-1088
        • Semmelweis University, Department of Internal Medicine and Haematology, Division of Internal Medicine and Gastroenterology
      • Gyöngyös, Hungary, 3200
        • Bugat Pal Korhaz
      • Székesfehérvár, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
      • Székesfehérvár, Hungary, H-8000
        • Fejer County St. Gyorgy University Teaching Hospital
      • Vác, Hungary, 2600
        • Jávorszky Ödön Kórház
  • India
      • Gūrgaon, India, 122002
        • Fortis Memorial Research Institute(FMRI)
      • Hyderabad, India, 500004
        • Gleneagles hospital
      • Jaipur, India, 302004
        • Sawai Man Singh Medical College Hospital (SMS Hospital)
      • Jaipur, India, 302006
        • S R Kalla Memorial Gastro and General Hospital
      • Ludhiana, India, 141001
        • Dayanand Medical College and Hospital
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • Noida, India, 201301
        • Fortis Hospital
      • Secunderabad, India, 500003
        • Yashoda Hospital
      • Surat, India, 395002
        • SIDS Hospital and Research Centre
      • Thiruvananthapuram, India, 695011
        • Government Medical College
  • Israel
      • Jerusalem, Israel, 91004
        • Shaare Zedek Medical Center, Digestive Diseases Institute
      • Rehovot, Israel, 7661041
        • Kaplan Medical Center, Institute of Gastroenterology and Liver Diseases
  • Italy
      • Milan, Italy, 20157
        • Ospedale Luigi Sacco
      • Padua, Italy, 35128
        • Hospital of Padova
      • Rozzano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
      • San Giovanni Rotondo, Italy, 71013
        • IRCCS Ospedale Casa Sollievo della Sofferenza
      • Segrate, Italy, 20132
        • IRCCS Ospedale San Raffaele
  • Latvia
      • Liepāja, Latvia, LV-3414
        • Liepaja Regional Hospital
      • Riga, Latvia, 1079
        • Digestive Diseases Center "Gastro"
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical Univeristy Hospital
  • Lithuania
      • Panevezys, Lithuania, 35144
        • Republican Panevezys Hospital
      • Vilnius, Lithuania, LT-08406
        • Vilnius University Hospital Santaros Klinikos
  • Poland
      • Bydgoszcz, Poland, 85-794
        • CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
      • Elblag, Poland, 82-300
        • St. John Paul 2nd Municipal Hospital in Elblag
      • Katowice, Poland, 40-748
        • "Vita Longa" Non-Public Healthcare Facility, Limited Liability Company
      • Krakow, Poland, 31-501
        • Krakow Medical Center
      • Lodz, Poland, 90-752
        • IP Clinic
      • Lublin, Poland, 20-412
        • ETG Lublin
      • Lublin, Poland, 20-090
        • University Teaching Hospital No. 4 in Lublin
      • Opole, Poland, 45 819
        • Twoja Przychodnia Opolskie Centrum Medyczne
      • Poznan, Poland, 60-309
        • EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
      • Poznan, Poland, 60-324
        • Twoja Przychodnia PCM
      • Sopot, Poland, 81-756
        • Endoscopy Limited Liability Company
      • Staszów, Poland, 28-200
        • New health-CK, Kieltucki and partners g.p.
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Tychy, Poland, 43-100
        • H-T. Medical Center
      • Warsaw, Poland, 04-501
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warsaw, Poland, 02-665
        • Centrum Medyczne Reuma Park
      • Wroclaw, Poland, 54-144
        • EMC Medical Institute Joint Stock Company, EuroMediCare Specialist Outpatient Clinics in Wroclaw
      • Zamość, Poland, 22-400
        • ETG Zamość
  • Romania
      • Bucharest, Romania, 020125
        • Colentina Clinical Hospital
      • Bucharest, Romania, 21494
        • Center of Diagnosis and Treatment Provita
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, Serbia, 11 000
        • Zvezdara University Medical Center
      • Zrenjanin, Serbia, 23000
        • General Hospital "Djordje Joanovic"
  • Slovakia
      • Bratislava, Slovakia, 811 09
        • Cliniq s.r.o.
      • Košice, Slovakia, 04013
        • ENDOMED s.r.o.
      • Prešov, Slovakia, 08001
        • Gastro LM s.r.o.
  • South Korea
      • Busan, South Korea, 49201
        • Dong-A University Hospital
      • Daegu, South Korea, 42415
        • Yeungnam Univeristy Medical Center
      • Seoul, South Korea, 02447
        • Kyung Hee University Hospital
  • Taiwan
      • Changhua, Taiwan, 50006
        • Changhua Christian Hospital
      • Chiayi City, Taiwan, 600
        • Chia-Yi Christian Hospital
      • Neihu Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan, 112201
        • Taipei Veterans General Hospital
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Arizona Digestive Health - Sun City
    • California
      • Lancaster, California, United States, 93534
        • Gastro Care Institute
      • Los Angeles, California, United States, 90048
        • TLC Clinical Research Inc.
    • Florida
      • Coral Gables, Florida, United States, 33145
        • Innova Clinical Trials
      • Miramar, Florida, United States, 33027
        • Eminat, LLC - Miramar
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Medical School
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening
  • Has evidence of UC extending at least 15 cm from the anal verge
  • Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase [JAK] antagonists, or sphingosine-1-phosphate [S1P] receptor agonists)
  • Subject has no prior exposure to approved or investigational anti-integrin therapies
  • Agrees to abide by the study guidelines and requirements
  • Capable of giving signed informed consent

Exclusion Criteria:

  • 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
  • Previous treatment with vedolizumab or other licensed or investigational 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MORF-057 200 mg BID
Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks.
Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Other Names:
  • LY4268989
Experimental: MORF-057 100 mg BID
Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Other Names:
  • LY4268989
Experimental: MORF-057 100 mg QD-M
Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks.
Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Other Names:
  • LY4268989
Placebo Comparator: Placebo
Participants received an oral dose of matching placebo for 12 weeks.
Drug: Placebo
Matching placebo (identical appearance to MORF-057) administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS)
Time Frame: Week 12
  • The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease.
  • Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of < or =1; and an endoscopy subscore of < or =1 without friability.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Clinical Response as Determined Using the Modified Mayo Clinic Score (mMCS)
Time Frame: Week 12
  • The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease.
  • Clinical response per mMCS is defined as decrease from baseline in the mMCS score > or =2 points and > or =30% from baseline, plus a decrease in rectal bleeding subscore > or =1 or an absolute rectal bleeding subscore < or =1.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27398
  • MORF-057-202 (Other Identifier: Morphic Therapeutic, Inc)
  • J6E-MC-KWAD (Other Identifier: Eli Lilly and Company)
  • 2022-500953-17-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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