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Crohn DiseasePhase 2NCT07483099

A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease

A Phase 2 study testing LY4395089, Mirikizumab - Intravenous (IV) and Mirikizumab - Subcutaneous (SC) in people with Crohn Disease, run by Eli Lilly and Company at 71 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Crohn Disease
What is being tested?
LY4395089, Mirikizumab - Intravenous (IV) and Mirikizumab - Subcutaneous (SC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
71 sitesin 10 countries
Study dates
4 May 2026to Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:
  • Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1/glucagon (Gcg) RAs, GLP-1/GIP/Gcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening

Who cannot join

  • Participants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:
  • Must not have a hepatic disease
  • Must not have a history of any other bone disease that affects bone metabolism
  • Must not have had any of the following within the past 180 days before screening:
  • acute myocardial infarction
  • cerebrovascular incident
Show all 10Show fewer
  • hospitalization for unstable angina
  • hospitalization due to congestive heart failure, or
  • coronary revascularization
  • Must not have received or will need any other prohibited medications as specified in the protocol

Trial locations and contacts

71 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

clinical_inquiry_hub@lilly.com

71 sites in 10 countries

United States14 sites, 13 recruiting

  • Atlanta Gastroenterology Associates - Peachtree Dunwoody

    Atlanta, Georgia, 30342

    Nitin Gupta

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Atsushi Sakuraba

    Not yet recruiting

  • South Denver Gastroenterology

    Englewood, Colorado, 80113

    Marcelo Kugelmas

    Recruiting

  • One of a Kind Clinical Research Center - Kingwood

    Kingwood, Texas, 77339

    Sushovan Guha

    Recruiting

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

    Christian Stone

    Recruiting

  • Biopharma Informatic, LLC

    Los Angeles, California, 90035

    Morris Silver, MD

    Not yet recruiting

  • Gastro Health Research - Miami

    Miami, Florida, 33176

    Lukasz Kwapisz

    Recruiting

  • Ezy Medical Research

    Miami Lakes, Florida, 33015

    Hendry Perez-Pascual

    Recruiting

  • Om Research LLC

    Oxnard, California, 93030

    Karen Simon

    Recruiting

  • Southern Star Research Institute

    San Antonio, Texas, 78229

    Jeff Bullock

    Recruiting

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, Arizona, 85259

    Suspended

  • KAD Clinical Research

    St Louis, Missouri, 63123

    Adrian Di Bisceglie

    Recruiting

  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas, 66606

    Curtis Baum

    Recruiting

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

    Wyoming, Michigan, 49519

    Allan Coates

    Not yet recruiting

Other trials in United States

Poland10 sites, 10 recruiting

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

    Katowice, 40-600

    Marek Olakowski

    Recruiting

  • Centrum Medyczne Oslomed

    Krakow, 31-228

    Anna Drozdz

    Recruiting

  • Medrise Sp. z o.o.

    Lublin, 20-582

    Wit Danilkiewicz

    Not yet recruiting

  • Twoja Przychodnia PCM

    Poznan, 60-324

    Ewa Furmanowska-Ladorska

    Recruiting

  • ETG Siedlce

    Siedlce, 08-110

    Anna Lewandowska

    Recruiting

  • Twoja Przychodnia SCM

    Szczecin, 71-434

    Beata Gawdis-Wojnarska

    Recruiting

  • Sonomed Sp. z o. o.

    Szczecin, 71-685

    Anna Wiechowska-Kozlowska

    Recruiting

  • WSD MEDI

    Warsaw, 02-786

    Michal Krogulecki

    Not yet recruiting

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

    Warsaw, 04-501

    Jaroslaw Kierkus

    Recruiting

  • ETG Zamość

    Zamość, 22-400

    Katarzyna Wojcik

    Recruiting

Other trials in Poland

Brazil9 sites, 9 recruiting

  • Loema Instituto de Pesquisa Clinica

    Campinas, 13092-133

    Joaquim Simoes Neto

    Recruiting

  • Fundação Universidade de Caxias do Sul (FUCS)

    Caxias do Sul, 95070-560

    Eduardo Brambilla

    Recruiting

  • Centro Digestivo de Curitiba

    Curitiba, 80430-180

    Odery Ramos Júnior

    Recruiting

  • Centro de Pesquisa Clínica de Marília - CPCLIM

    Marília, 17504-072

    FABIO TEIXEIRA

    Recruiting

  • CPHosp Medicina, Ensino e Pesquisa (CPQuali)

    São Paulo, 01228-000

    Rafael Lages

    Recruiting

  • CPCLIN

    São Paulo, 01228-200

    Adolpho Alexander da Silva

    Recruiting

  • BR Trials - Ensaios Clinicos e Consultoria

    São Paulo, 01236030

    Roberto da Silva

    Recruiting

  • Clínica Hepatogastro JK

    São Paulo, 04077-020

    Rodrigo Andrey Rocco

    Recruiting

  • CEDOES

    Vitória, 29055450

    Felipe Ferreira

    Recruiting

Other trials in Brazil

China9 sites, 9 recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

    Xuehong Wang

    Recruiting

  • Changzhou Second People's Hospital

    Changzhou, 213000

    Wenjia LIU

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

    Baili Chen

    Recruiting

  • The Second Affiliated hospital of Zhejiang University school of medicine

    Hangzhou, 310052

    Yan Chen

    Recruiting

  • Huizhou Central People's Hospital

    Huizhou, 516001

    Huixin Chen

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004

    Wen Tang

    Recruiting

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

    Wenzhou, 325000

    yi Jiang

    Recruiting

  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen, 361000

    Yanyun Fan

    Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212000

    Min Xu

    Recruiting

Other trials in China

Israel7 sites, 7 recruiting

  • Assuta Ashdod Medical Center

    Ashdod, 7747629

    Adi Lahat-Zok

    Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    Roni Weisshof

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Benjamin Koslowsky

    Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001

    ADAR ZINGER

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Irit Avni-Biron

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 5262100

    Asaf Levartovsky

    Recruiting

  • Yitzhak Shamir Medical Center

    Tsrifin, 7033001

    Vered Richter

    Recruiting

Other trials in Israel

Italy6 sites, 6 recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

    Gabriele Dragoni

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Silvio Danese

    Not yet recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

    Chiara Viganò

    Not yet recruiting

  • Ospedale Sacro Cuore Don G. Calabria

    Negrar, 37024

    Angela Variola

    Not yet recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Franco Scaldaferri

    Not yet recruiting

  • Humanitas

    Rozzano, 20089

    Alessandro Armuzzi

    Not yet recruiting

Other trials in Italy

Germany5 sites, 4 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117

    Christoph Jochum

    Not yet recruiting

  • Studienzentrum MVZ Dachau

    Dachau, 85221

    Suspended

  • Studiengesellschaft Mitteldeutschland GmbH

    Halle, 06108

    Lars Fechner

    Recruiting

  • St. Marien- und St. Annastiftskrankenhaus

    Ludwigshafen, 67067

    Tanja Kuehbacher

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    Jochen Klaus

    Not yet recruiting

Other trials in Germany

Belgium4 sites, 4 recruiting

  • AZ Maria Middelares

    Ghent, 9000

    Didier Baert

    Recruiting

  • UZ Gent

    Ghent, 9000

    Jeroen Geldof

    Not yet recruiting

  • UZ Leuven

    Leuven, 3000

    Bram Verstockt

    Recruiting

  • AZ Delta vzw

    Roeselare, 8800

    Filip Baert

    Recruiting

Other trials in Belgium

Canada4 sites, 4 recruiting

  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

    Greenfield Park, J4V 2H1

    Andrew Wisniewski

    Not yet recruiting

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

    Lethbridge, T1J 4G9

    Kaleb Marr

    Not yet recruiting

  • London Digestive Disease Institute

    London, N6K 1M6

    Vipul Jairath

    Not yet recruiting

  • Tdda Inc.

    Vaughan, L4L 4Y7

    David Ford

    Recruiting

Other trials in Canada

Hungary3 sites, 3 recruiting

  • Geomedical Egészségügyi Központ

    Budapest, 1066

    Gabor Hegede

    Recruiting

  • Semmelweis Egyetem

    Budapest, 1082

    Pal Miheller

    Recruiting

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800

    Samer Francis

    Recruiting

Other trials in Hungary

About this study

Official title: A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease

The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.

Conditions
Crohn Disease
Being tested
LY4395089, Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC)
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY4395089Drug

    Administered orally

  • Mirikizumab - Intravenous (IV)Drug

    Also called LY3074828

    Administered IV

  • Mirikizumab - Subcutaneous (SC)Drug

    Also called LY3074828

    Administered SC

Study groups in NCT07483099
Study groupRoleWhat they receive
MirikizumabActive comparatorStudy Period 1: Mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
Receives: Drug: Mirikizumab - Intravenous (IV); Drug: Mirikizumab - Subcutaneous (SC)
LY4395089 and Mirikizumab Co-AdministrationExperimentalStudy Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
Receives: Drug: LY4395089; Drug: Mirikizumab - Intravenous (IV); Drug: Mirikizumab - Subcutaneous (SC)

What is being measured

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

  1. Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response

    The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.

    Measured: Baseline, Up to Week 12

Secondary outcomes (2)

  1. Percentage of Participants who Achieve Clinical Remission

    Measured: Baseline, Up to Week 12

  2. Percent Change from Baseline in Fecal Calprotectin

    Measured: Baseline, Up to 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 posted19 Mar 2026
  2. Study start4 May 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionMar 2028 (estimated)

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
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483099
Sponsor's protocol ID
27810
Other IDs
J6Z-MC-CD01, J6Z-MC-IIBD
Status last verified
Nov 2026
First submitted
16 Mar 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY4395089, Mirikizumab - Intravenous (IV) and Mirikizumab - Subcutaneous (SC) in people with Crohn Disease, run by Eli Lilly and Company at 71 sites in 10 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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Poland, Brazil, China, Israel and 5 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, clinical_inquiry_hub@lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response (time frame: Baseline, Up to 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 NCT07483099.

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 4 Nov 2026.

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