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New hope for gut disease: experimental drugs enter human trials

NCT ID NCT07483073

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 9 times

Summary

This phase 2 study is testing two new drugs — mirikizumab (given by IV or injection) and LY4395089 (a pill) — in 60 adults with moderately to severely active ulcerative colitis or Crohn's disease. The goal is to see if these treatments are safe and can help control the disease. The study lasts at least 62 weeks and is currently recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mirikizumab (given by IV or injection) and LY4395089 (taken by mouth)
What this could lead to
If successful, this could point toward new treatment options that help control symptoms and reduce disease activity for people with ulcerative colitis or Crohn's disease.
What could go wrong
This is an early phase 2 trial with only 60 participants, so results may not apply to everyone. The drugs may not work better than existing treatments or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD. * For UC: * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2. * For CD: * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization * Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD * Have screening laboratory test results within the protocol specified parameters. Exclusion Criteria: * Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis * For UC - must not have a current diagnosis of CD * For CD - must not have a current diagnosis of UC * Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol * Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome * Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data * Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action * Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment * Must not have received or will need any prohibited medications for UC or CD as specified in the protocol

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative Crohn disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    70 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Delta vzw

    NOT_YET_RECRUITING

    Roeselare, 8800, Belgium

  • AZ Maria Middelares

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

  • Affiliated Hospital of Jiangsu University

    RECRUITING

    Zhenjiang, 212000, China

  • Assuta Ashdod Medical Center

    RECRUITING

    Ashdod, 7747629, Israel

  • Atlanta Gastroenterology Associates - Peachtree Dunwoody

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Azienda Ospedaliera Universitaria Careggi

    NOT_YET_RECRUITING

    Florence, 50134, Italy

  • BR Trials - Ensaios Clinicos e Consultoria

    NOT_YET_RECRUITING

    São Paulo, 01236030, Brazil

  • Biopharma Informatic, LLC

    RECRUITING

    Los Angeles, California, 90035, United States

  • CEDOES

    NOT_YET_RECRUITING

    Vitória, 29055450, Brazil

  • CPCLIN

    NOT_YET_RECRUITING

    São Paulo, 01228-200, Brazil

  • CPHosp Medicina, Ensino e Pesquisa (CPQuali)

    NOT_YET_RECRUITING

    São Paulo, 01228-000, Brazil

  • Centro Digestivo de Curitiba

    NOT_YET_RECRUITING

    Curitiba, 80430-180, Brazil

  • Centro de Pesquisa Clínica de Marília - CPCLIM

    NOT_YET_RECRUITING

    Marília, 17504-072, Brazil

  • Centrum Medyczne Oslomed

    NOT_YET_RECRUITING

    Krakow, 31-228, Poland

  • Changzhou Second People's Hospital

    RECRUITING

    Changzhou, 213000, China

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    NOT_YET_RECRUITING

    Berlin, 10117, Germany

  • Clínica Hepatogastro JK

    NOT_YET_RECRUITING

    São Paulo, 04077-020, Brazil

  • Cotton O'Neil Digestive Health Center

    RECRUITING

    Topeka, Kansas, 66606, United States

  • ETG Siedlce

    NOT_YET_RECRUITING

    Siedlce, 08-110, Poland

  • ETG Zamość

    NOT_YET_RECRUITING

    Zamość, 22-400, Poland

  • Ezy Medical Research

    RECRUITING

    Miami Lakes, Florida, 33015, United States

  • Fondazione IRCCS San Gerardo dei Tintori

    NOT_YET_RECRUITING

    Monza, 20900, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • Fundação Universidade de Caxias do Sul (FUCS)

    NOT_YET_RECRUITING

    Caxias do Sul, 95070-560, Brazil

  • Gastro Health Research - Miami

    RECRUITING

    Miami, Florida, 33176, United States

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

    RECRUITING

    Wyoming, Michigan, 49519, United States

  • Geomedical Egészségügyi Központ

    NOT_YET_RECRUITING

    Budapest, 1066, Hungary

  • Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

    NOT_YET_RECRUITING

    Katowice, 40-600, Poland

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 9112001, Israel

  • Huizhou Central People's Hospital

    RECRUITING

    Huizhou, 516001, China

  • Humanitas

    NOT_YET_RECRUITING

    Rozzano, 20089, Italy

  • KAD Clinical Research

    RECRUITING

    St Louis, Missouri, 63123, United States

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    RECRUITING

    Tatabánya, 2800, Hungary

  • Loema Instituto de Pesquisa Clinica

    NOT_YET_RECRUITING

    Campinas, 13092-133, Brazil

  • London Digestive Disease Institute

    SUSPENDED

    London, N6K 1M6, Canada

  • Mayo Clinic in Arizona - Scottsdale

    SUSPENDED

    Scottsdale, Arizona, 85259, United States

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    NOT_YET_RECRUITING

    Warsaw, 04-501, Poland

  • Medrise Sp. z o.o.

    NOT_YET_RECRUITING

    Lublin, 20-582, Poland

  • Om Research LLC

    RECRUITING

    Oxnard, California, 93030, United States

  • One of a Kind Clinical Research Center - Kingwood

    NOT_YET_RECRUITING

    Kingwood, Texas, 77339, United States

  • Ospedale Sacro Cuore Don G. Calabria

    NOT_YET_RECRUITING

    Negrar, 37024, Italy

  • Ospedale San Raffaele

    NOT_YET_RECRUITING

    Milan, 20132, Italy

  • Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)

    NOT_YET_RECRUITING

    Lethbridge, T1J 4G9, Canada

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Rush University Medical Center

    NOT_YET_RECRUITING

    Chicago, Illinois, 60612, United States

  • Semmelweis Egyetem

    NOT_YET_RECRUITING

    Budapest, 1082, Hungary

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 5262100, Israel

  • Sonomed Sp. z o. o.

    NOT_YET_RECRUITING

    Szczecin, 71-685, Poland

  • South Denver Gastroenterology

    RECRUITING

    Englewood, Colorado, 80113, United States

  • Southern Star Research Institute

    RECRUITING

    San Antonio, Texas, 78229, United States

  • St. Marien- und St. Annastiftskrankenhaus

    NOT_YET_RECRUITING

    Ludwigshafen, 67067, Germany

  • Studiengesellschaft Mitteldeutschland GmbH

    NOT_YET_RECRUITING

    Halle, 06108, Germany

  • Studienzentrum MVZ Dachau

    NOT_YET_RECRUITING

    Dachau, 85221, Germany

  • Tdda Inc.

    RECRUITING

    Vaughan, L4L 4Y7, Canada

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, 510080, China

  • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

    RECRUITING

    Wenzhou, 325000, China

  • The Second Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, 215004, China

  • The Second Affiliated hospital of Zhejiang University school of medicine

    RECRUITING

    Hangzhou, 310052, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, 410011, China

  • Twoja Przychodnia PCM

    NOT_YET_RECRUITING

    Poznan, 60-324, Poland

  • Twoja Przychodnia SCM

    NOT_YET_RECRUITING

    Szczecin, 71-434, Poland

  • UZ Gent

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

  • UZ Leuven

    NOT_YET_RECRUITING

    Leuven, 3000, Belgium

  • Universitaetsklinikum Ulm

    NOT_YET_RECRUITING

    Ulm, 89081, Germany

  • Vector Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • WSD MEDI

    NOT_YET_RECRUITING

    Warsaw, 02-786, Poland

  • Yitzhak Shamir Medical Center

    RECRUITING

    Ẕerifin, 7033001, Israel

  • Zhongshan Hospital Affiliated to Xiamen University

    RECRUITING

    Xiamen, 361000, China

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Other studies related to the condition(s) this trial covers.