A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

NCT05611671 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 4 other identifiers: 27398J6E-MC-KWADMORF-057-2022022-500953-17-00
• Study Type: interventional
• Target: 280
• Locations: 20 countries
• Sites: 99

Brief 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).

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Keywords

Ulcerative Colitis (UC); Inflammatory Bowel Disease (IBD); a4b7; Moderate-to-severe; Integrin; EMERALD

Outcome Measures

Primary Outcomes (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.

  Week 12

Secondary Outcomes (1)

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

  Week 12

Study Arms (4)

MORF-057 200 mg BID

EXPERIMENTAL

Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks.

Drug: MORF-057

MORF-057 100 mg BID

EXPERIMENTAL

Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.

Drug: MORF-057

MORF-057 100 mg QD-M

EXPERIMENTAL

Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks.

Drug: MORF-057

Placebo

PLACEBO COMPARATOR

Participants received an oral dose of matching placebo for 12 weeks.

Drug: Placebo

Interventions

MORF-057 DRUG

MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Also known as: LY4268989

MORF-057 100 mg BID; MORF-057 100 mg QD-M; MORF-057 200 mg BID

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company): lead

Study Sites (102)

Arizona Digestive Health - Sun City

Sun City, Arizona, 85351, United States

Location

Gastro Care Institute

Lancaster, California, 93534, United States

Location

TLC Clinical Research Inc.

Los Angeles, California, 90048, United States

Location

Innova Clinical Trials

Coral Gables, Florida, 33145, United States

Location

Eminat, LLC - Miramar

Miramar, Florida, 33027, United States

Location

Robert Wood Johnson University Medical School

New Brunswick, New Jersey, 08901, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Blacktown Hospital

Blacktown, 2148, Australia

Location

Concord Repatriation General Hospital

Concord, 2139, Australia

Location

Royal Brisbane and Women's Hospital

Herston, QLD 4029, Australia

Location

Fiona Stanley Hospital

Murdoch, 6150, Australia

Location

Mater Adult Hospital Brisbane

South Brisbane, 4101, Australia

Location

Order Hospital Linz Ltd. - Hospital of Sisters of Mercy

Linz, 4010, Austria

Location

Salzburg Regional Hospital

Salzburg, 5020, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Medical Center "Rusemed" EOOD

Rousse, 7005, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic"

Sofia, 1202, Bulgaria

Location

Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda

Sofia, 1407, Bulgaria

Location

Second Multiprofile Hospital for Active Treatment - Sofia

Sofia, 2700, Bulgaria

Location

PreventaMed, s.r.o.

Olomouc, 77900, Czechia

Location

Clinoxus s.r.o., Outpatient Clinic Budejovicka

Prague, 140 00, Czechia

Location

LV Venter OU

Pärnu, 80010, Estonia

Location

OU Innomedica

Tallinn, 10117, Estonia

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

West Tallinn Central Hospital

Tallinn, 10617, Estonia

Location

University of Tartu

Tartu, 51014, Estonia

Location

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, 06202, France

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

Tbilisi, 0101, Georgia

Location

Curatio, Jsc

Tbilisi, 0114, Georgia

Location

JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, 0159, Georgia

Location

LTD Aversi Clinic

Tbilisi, 0160, Georgia

Location

Medical Center "CITO" Ltd.

Tbilisi, 0179, Georgia

Location

LTD The First Medical Center

Tbilisi, 0180, Georgia

Location

Charite - University Hospital Berlin

Berlin, 10117, Germany

Location

Krankenhaus Waldfriede

Berlin, 14163, Germany

Location

University Hospital Schleswig-Holstein

Kiel, 24105, Germany

Location

University Hospital Ulm

Ulm, 89081, Germany

Location

Semmelweis Medical University

Budapest, 1083, Hungary

Location

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

Budapest, H-1088, Hungary

Location

Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

Location

Fejér Megyei Szent György Egyetemi Oktató Kórház

Székesfehérvár, 8000, Hungary

Location

Fejer County St. Gyorgy University Teaching Hospital

Székesfehérvár, H-8000, Hungary

Location

Javorszky Odon Korhaz

Vác, 2600, Hungary

Location

Fortis Memorial Research Institute(FMRI)

Gūrgaon, 122002, India

Location

Gleneagles Hospital

Hyderabad, 500004, India

Location

Sawai Man Singh Medical College Hospital (SMS Hospital)

Jaipur, 302004, India

Location

S R Kalla Memorial Gastro and General Hospital

Jaipur, 302006, India

Location

Dayanand Medical College and Hospital

Ludhiana, 141001, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Fortis Hospital

Noida, 201301, India

Location

Yashoda Hospital

Secunderabad, 500003, India

Location

SIDS Hospital and Research Centre

Surat, 395002, India

Location

Government Medical College

Thiruvananthapuram, 695011, India

Location

Shaare Zedek Medical Center, Digestive Diseases Institute

Jerusalem, 91004, Israel

Location

Kaplan Medical Center, Institute of Gastroenterology and Liver Diseases

Rehovot, 7661041, Israel

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Hospital of Padova

Padua, 35128, Italy

Location

IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali

Rozzano, 20089, Italy

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

IRCCS Ospedale San Raffaele

Segrate, 20132, Italy

Location

Liepaja Regional Hospital

Liepāja, LV-3414, Latvia

Location

Digestive Diseases Center "Gastro"

Riga, 1079, Latvia

Location

Pauls Stradins Clinical Univeristy Hospital

Riga, LV-1002, Latvia

Location

Republican Panevezys Hospital

Panevezys, 35144, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, LT-08406, Lithuania

Location

CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska

Bydgoszcz, 85-794, Poland

Location

St. John Paul 2nd Municipal Hospital in Elblag

Elblag, 82-300, Poland

Location

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

Katowice, 40-748, Poland

Location

Krakow Medical Center

Krakow, 31-501, Poland

Location

IP Clinic

Lodz, 90-752, Poland

Location

University Teaching Hospital No. 4 in Lublin

Lublin, 20-090, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, 45 819, Poland

Location

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

Poznan, 60-309, Poland

Location

Twoja Przychodnia Pcm

Poznan, 60-324, Poland

Location

Endoscopy Limited Liability Company

Sopot, 81-756, Poland

Location

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

Staszów, 28-200, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

H-T. Medical Center

Tychy, 43-100, Poland

Location

Centrum Medyczne Reuma Park

Warsaw, 02-665, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-501, Poland

Location

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

Wroclaw, 54-144, Poland

Location

ETG Zamość

Zamość, 22-400, Poland

Location

Colentina Clinical Hospital

Bucharest, 020125, Romania

Location

Center of Diagnosis and Treatment Provita

Bucharest, 21494, Romania

Location

Zvezdara University Medical Center

Belgrade, 11 000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11000, Serbia

Location

General Hospital "Djordje Joanovic"

Zrenjanin, 23000, Serbia

Location

Cliniq s.r.o.

Bratislava, 811 09, Slovakia

Location

ENDOMED s.r.o.

Košice, 04013, Slovakia

Location

Gastro LM s.r.o.

Prešov, 08001, Slovakia

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Yeungnam Univeristy Medical Center

Daegu, 42415, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

Chia-Yi Christian Hospital

Chiayi City, 600, Taiwan

Location

Tri-Service General Hospital

Neihu Taipei, 11490, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112201, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 10, 2022
• Study Start: November 21, 2022
• Primary Completion: November 28, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-11

Locations

HU (6); SL (3); KR (3); ES (5); DE (4); BU (4); TW (7); US (8); IL (2); PL (18); RO (2); CZ (2); FR (1); IN (10); LA (3); AU (5); LI (2); GE (6); IT (5); SE (3)