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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

280

Phase

  • 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 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 - Hôpital 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
        • Javorszky Odon Korhaz
  • 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 Zamosc
  • 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

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
Intervention / Treatment
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

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

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

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)

November 21, 2022

Primary Completion (Actual)

November 28, 2024

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Inflammatory Bowel Diseases

Clinical Trials on MORF-057

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe