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Inflammatory Bowel DiseasesPhase 2EMERALD-2NCT05611671

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active 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 102 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
MORF-057
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
280 participants
Where
102 sitesin 21 countries
Study dates
21 Nov 2022to 21 Sep 2026
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 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

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
  • 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

Trial locations and contacts

102 sites in 21 countries.

102 sites in 21 countries

Poland18 sites

  • CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska

    Bydgoszcz, 85-794

  • St. John Paul 2nd Municipal Hospital in Elblag

    Elblag, 82-300

  • "Vita Longa" Non-Public Healthcare Facility, Limited Liability Company

    Katowice, 40-748

  • Krakow Medical Center

    Krakow, 31-501

  • IP Clinic

    Lodz, 90-752

  • University Teaching Hospital No. 4 in Lublin

    Lublin, 20-090

  • ETG Lublin

    Lublin, 20-412

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, 45 819

  • EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1

    Poznan, 60-309

  • Twoja Przychodnia Pcm

    Poznan, 60-324

  • Endoscopy Limited Liability Company

    Sopot, 81-756

  • New health-CK, Kieltucki and partners g.p.

    Staszów, 28-200

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • H-T. Medical Center

    Tychy, 43-100

  • Centrum Medyczne Reuma Park

    Warsaw, 02-665

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501

  • EMC Medical Institute Joint Stock Company, EuroMediCare Specialist Outpatient Clinics in Wroclaw

    Wroclaw, 54-144

  • ETG Zamość

    Zamość, 22-400

Other trials in Poland

India10 sites

  • Fortis Memorial Research Institute(FMRI)

    Gūrgaon, 122002

  • Gleneagles Hospital

    Hyderabad, 500004

  • Sawai Man Singh Medical College Hospital (SMS Hospital)

    Jaipur, 302004

  • S R Kalla Memorial Gastro and General Hospital

    Jaipur, 302006

  • Dayanand Medical College and Hospital

    Ludhiana, 141001

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Fortis Hospital

    Noida, 201301

  • Yashoda Hospital

    Secunderabad, 500003

  • SIDS Hospital and Research Centre

    Surat, 395002

  • Government Medical College

    Thiruvananthapuram, 695011

Other trials in India

United States8 sites

  • Innova Clinical Trials

    Coral Gables, Florida, 33145

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Gastro Care Institute

    Lancaster, California, 93534

  • TLC Clinical Research Inc.

    Los Angeles, California, 90048

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • Eminat, LLC - Miramar

    Miramar, Florida, 33027

  • Robert Wood Johnson University Medical School

    New Brunswick, New Jersey, 08901

  • Arizona Digestive Health - Sun City

    Sun City, Arizona, 85351

Other trials in United States

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • Chia-Yi Christian Hospital

    Chiayi City, 600

  • Tri-Service General Hospital

    Neihu Taipei, 11490

  • China Medical University Hospital

    Taichung, 404

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 112201

  • Far Eastern Memorial Hospital

    Taipei, 220

Other trials in Taiwan

Georgia6 sites

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

    Tbilisi, 0101

  • Curatio, Jsc

    Tbilisi, 0114

  • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

    Tbilisi, 0159

  • LTD Aversi Clinic

    Tbilisi, 0160

  • Medical Center "CITO" Ltd.

    Tbilisi, 0179

  • LTD The First Medical Center

    Tbilisi, 0180

Other trials in Georgia

Hungary6 sites

  • Semmelweis Medical University

    Budapest, 1083

  • Semmelweis University, Department of Internal Medicine and Haematology, Division of Internal Medicine and Gastroenterology

    Budapest, H-1088

  • Bugat Pal Korhaz

    Gyöngyös, 3200

  • Fejér Megyei Szent György Egyetemi Oktató Kórház

    Székesfehérvár, 8000

  • Fejer County St. Gyorgy University Teaching Hospital

    Székesfehérvár, H-8000

  • Javorszky Odon Korhaz

    Vác, 2600

Other trials in Hungary

Australia5 sites

  • Blacktown Hospital

    Blacktown, 2148

  • Concord Repatriation General Hospital

    Concord, 2139

  • Royal Brisbane and Women's Hospital

    Herston, QLD 4029

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Mater Adult Hospital Brisbane

    South Brisbane, 4101

Other trials in Australia

Estonia5 sites

  • LV Venter OU

    Pärnu, 80010

  • OU Innomedica

    Tallinn, 10117

  • East Tallinn Central Hospital

    Tallinn, 10138

  • West Tallinn Central Hospital

    Tallinn, 10617

  • University of Tartu

    Tartu, 51014

Other trials in Estonia

Italy5 sites

  • Ospedale Luigi Sacco

    Milan, 20157

  • Hospital of Padova

    Padova, 35128

  • IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali

    Rozzano, 20089

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • IRCCS Ospedale San Raffaele

    Segrate, 20132

Other trials in Italy

Bulgaria4 sites

  • Medical Center "Rusemed" EOOD

    Rousse, 7005

  • University Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic"

    Sofia, 1202

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda

    Sofia, 1407

  • Second Multiprofile Hospital for Active Treatment - Sofia

    Sofia, 2700

Other trials in Bulgaria

Germany4 sites

  • Charite - University Hospital Berlin

    Berlin, 10117

  • Krankenhaus Waldfriede

    Berlin, 14163

  • University Hospital Schleswig-Holstein

    Kiel, 24105

  • University Hospital Ulm

    Ulm, 89081

Other trials in Germany

Austria3 sites

  • Order Hospital Linz Ltd. - Hospital of Sisters of Mercy

    Linz, 4010

  • Salzburg Regional Hospital

    Salzburg, 5020

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Latvia3 sites

  • Liepaja Regional Hospital

    Liepāja, LV-3414

  • Digestive Diseases Center "Gastro"

    Riga, 1079

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, LV-1002

Other trials in Latvia

Serbia3 sites

  • Zvezdara University Medical Center

    Belgrade, 11 000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11000

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000

Other trials in Serbia

Slovakia3 sites

  • Cliniq s.r.o.

    Bratislava, 811 09

  • ENDOMED s.r.o.

    Košice, 04013

  • Gastro LM s.r.o.

    Prešov, 08001

Other trials in Slovakia

South Korea3 sites

  • Dong-A University Hospital

    Busan, 49201

  • Yeungnam Univeristy Medical Center

    Daegu, 42415

  • Kyung Hee University Hospital

    Seoul, 02447

Other trials in South Korea

Czechia2 sites

  • PreventaMed, s.r.o.

    Olomouc, 77900

  • Clinoxus s.r.o., Outpatient Clinic Budejovicka

    Prague, 140 00

Other trials in Czechia

Israel2 sites

  • Shaare Zedek Medical Center, Digestive Diseases Institute

    Jerusalem, 91004

  • Kaplan Medical Center, Institute of Gastroenterology and Liver Diseases

    Rehovot, 7661041

Other trials in Israel

Lithuania2 sites

  • Republican Panevezys Hospital

    Panevezys, 35144

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08406

Other trials in Lithuania

Romania2 sites

  • Colentina Clinical Hospital

    Bucharest, 020125

  • Center of Diagnosis and Treatment Provita

    Bucharest, 21494

Other trials in Romania

France1 site

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, 06202

Other trials in France

About this study

Official title: 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).

Read the 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.

Being tested
MORF-057, Placebo
Keywords
Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), a4b7, Moderate-to-severe, Integrin, EMERALD
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.

  • PlaceboDrug

    Matching placebo (identical appearance to MORF-057) administered orally.

Study groups in NCT05611671
Study groupRoleWhat they receive
MORF-057 200 mg BIDExperimentalParticipants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks.
Receives: Drug: MORF-057
MORF-057 100 mg BIDExperimentalParticipants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
Receives: Drug: MORF-057
MORF-057 100 mg QD-MExperimentalParticipants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks.
Receives: Drug: MORF-057
PlaceboPlacebo comparatorParticipants received an oral dose of matching placebo for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS)

    • 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.

    Measured: Week 12

Secondary outcomes (1)

  1. Percentage of Participants in Clinical Response as Determined Using the Modified Mayo Clinic Score (mMCS)

    • 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2022
  2. Study start21 Nov 2022
  3. Primary completion28 Nov 2024
  4. Study completion21 Sep 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05611671
Sponsor's protocol ID
27398
Other IDs
J6E-MC-KWAD, MORF-057-202, 2022-500953-17-00
Acronym
EMERALD-2
Status last verified
Sep 2026
First submitted
31 Oct 2022
Last updated
15 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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 102 sites in 21 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 6 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in Poland, India, United States, Taiwan, Georgia and 16 more countries. 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. Some participants in this study may receive a placebo. 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 15 Dec 2025). 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?

Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS) (time frame: Week 12). 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 NCT05611671.

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 15 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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