Actively Recruiting
Study of LY4395089 With Mirikizumab Compared to Mirikizumab Alone in Adults With Moderately to Severely Active Crohn's Disease
Led by Eli Lilly and Company · Updated on 2026-06-04
60
Participants Needed
72
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a drug called LY4395089, which activates the farnesoid X receptor (FXR), when given together with mirikizumab compared to mirikizumab alone. This study focuses on adults with moderately to severely active Crohn's disease and is part of a larger research effort known as the IIBD master protocol. The study will last about 62 weeks and aims to better understand treatment options for Crohn's disease. Participants will be randomly assigned to one of two groups. In the first study period, one group will receive mirikizumab through an intravenous (IV) infusion, while the other group will receive both LY4395089 orally and mirikizumab IV. Responders to treatment will then move to the second study period where they will stop LY4395089 and continue receiving mirikizumab as a subcutaneous (SC) injection. During the study, participants will be closely monitored with evaluations to measure their response, including the percentage of participants achieving an endoscopic response by week 12. Other assessments will track clinical remission and changes in fecal calprotectin. The study involves multiple visits and procedures over the course of about 62 weeks to carefully assess the treatments' effects and safety.
CONDITIONS
Brief Title
A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet all inclusion criteria in the IIBD master protocol except those specific to ulcerative colitis
- Adults aged 18 to 80 years with moderately to severely active Crohn's disease
- Participants taking GLP-1 receptor agonists or similar medications for approved uses are allowed if on a stable dose at screening
You will not qualify if you...
- Participants with liver disease
- Participants with a history of any bone disease affecting bone metabolism
- Participants who had acute myocardial infarction, stroke, unstable angina hospitalization, congestive heart failure hospitalization, or coronary revascularization within 180 days before screening
- Participants who have received or will need prohibited medications as specified in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks
Participants receive either LY4395089 orally combined with intravenous mirikizumab, or mirikizumab alone intravenously during the first study period. Responders then receive mirikizumab subcutaneously during the second study period.
Multiple visits during treatment periods including intravenous and subcutaneous administration visits
Trial Site Locations
Total: 72 locations
1
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
2
Biopharma Informatic, LLC
Los Angeles, California, United States, 90035
Not Yet Recruiting
3
Om Research LLC
Oxnard, California, United States, 93030
Not Yet Recruiting
4
South Denver Gastroenterology
Englewood, Colorado, United States, 80113
Not Yet Recruiting
5
Gastro Health Research - Miami
Miami, Florida, United States, 33176
Not Yet Recruiting
6
Ezy Medical Research
Miami Lakes, Florida, United States, 33015
Actively Recruiting
7
Atlanta Gastroenterology Associates - Peachtree Dunwoody
Atlanta, Georgia, United States, 30342
Actively Recruiting
8
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not Yet Recruiting
9
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States, 66606
Actively Recruiting
10
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, Michigan, United States, 49519
Not Yet Recruiting
11
KAD Clinical Research
St Louis, Missouri, United States, 63123
Not Yet Recruiting
12
Vector Clinical Trials
Las Vegas, Nevada, United States, 89128
Actively Recruiting
13
Innovo Research - Wilmington Gastroenterology Associates
Wilmington, North Carolina, United States, 28403
Not Yet Recruiting
14
One of a Kind Clinical Research Center - Kingwood
Kingwood, Texas, United States, 77339
Not Yet Recruiting
15
Southern Star Research Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
16
AZ Maria Middelares
Ghent, Belgium, 9000
Not Yet Recruiting
17
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
18
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
19
AZ Delta vzw
Roeselare, Belgium, 8800
Not Yet Recruiting
20
Loema Instituto de Pesquisa Clinica
Campinas, Brazil, 13092-133
Not Yet Recruiting
21
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, Brazil, 95070-560
Not Yet Recruiting
22
Centro Digestivo de Curitiba
Curitiba, Brazil, 80430-180
Not Yet Recruiting
23
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, Brazil, 17504-072
Not Yet Recruiting
24
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
São Paulo, Brazil, 01228-000
Not Yet Recruiting
25
CPCLIN
São Paulo, Brazil, 01228-200
Not Yet Recruiting
26
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, Brazil, 01236030
Not Yet Recruiting
27
Solare Trials
São Paulo, Brazil, 01307-002
Not Yet Recruiting
28
Clínica Hepatogastro JK
São Paulo, Brazil, 04077-020
Not Yet Recruiting
29
CEDOES
Vitória, Brazil, 29055450
Not Yet Recruiting
30
Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)
Lethbridge, Canada, T1J 4G9
Not Yet Recruiting
31
London Digestive Disease Institute
London, Canada, N6K 1M6
Not Yet Recruiting
32
Tdda Inc.
Vaughan, Canada, L4L 4Y7
Not Yet Recruiting
33
The Second Xiangya Hospital of Central South University
Changsha, China, 410011
Not Yet Recruiting
34
Changzhou Second People's Hospital
Changzhou, China, 213000
Not Yet Recruiting
35
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China, 510080
Not Yet Recruiting
36
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, China, 310052
Not Yet Recruiting
37
Huizhou Central People's Hospital
Huizhou, China, 516001
Not Yet Recruiting
38
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
Not Yet Recruiting
39
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou, China, 325000
Not Yet Recruiting
40
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, China, 361000
Not Yet Recruiting
41
Affiliated Hospital of Jiangsu University
Zhenjiang, China, 212000
Not Yet Recruiting
42
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany, 10117
Not Yet Recruiting
43
Studienzentrum MVZ Dachau
Dachau, Germany, 85221
Not Yet Recruiting
44
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Germany, 06108
Not Yet Recruiting
45
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, Germany, 67067
Not Yet Recruiting
46
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Not Yet Recruiting
47
Geomedical Egészségügyi Központ
Budapest, Hungary, 1066
Not Yet Recruiting
48
Semmelweis Egyetem
Budapest, Hungary, 1082
Not Yet Recruiting
49
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, Hungary, 2800
Not Yet Recruiting
50
Assuta Ashdod Medical Center
Ashdod, Israel, 7747629
Not Yet Recruiting
51
Rambam Health Care Campus
Haifa, Israel, 3109601
Not Yet Recruiting
52
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Not Yet Recruiting
53
Hadassah Medical Center
Jerusalem, Israel, 9112001
Not Yet Recruiting
54
Rabin Medical Center
Petah Tikva, Israel, 4941492
Not Yet Recruiting
55
Sheba Medical Center
Ramat Gan, Israel, 5262100
Not Yet Recruiting
56
Yitzhak Shamir Medical Center
Ẕerifin, Israel, 7033001
Not Yet Recruiting
57
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50134
Not Yet Recruiting
58
Ospedale San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
59
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Not Yet Recruiting
60
Ospedale Sacro Cuore Don G. Calabria
Negrar, Italy, 37024
Not Yet Recruiting
61
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Not Yet Recruiting
62
Humanitas
Rozzano, Italy, 20089
Not Yet Recruiting
63
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, Poland, 40-600
Not Yet Recruiting
64
Oslomed Centrum Medyczne
Krakow, Poland, 31-228
Not Yet Recruiting
65
Medrise Sp. z o.o.
Lublin, Poland, 20-582
Not Yet Recruiting
66
Twoja Przychodnia PCM
Poznan, Poland, 60-324
Not Yet Recruiting
67
ETG Siedlce
Siedlce, Poland, 08-110
Not Yet Recruiting
68
Twoja Przychodnia SCM
Szczecin, Poland, 71-434
Not Yet Recruiting
69
Sonomed Sp. z o. o.
Szczecin, Poland, 71-685
Not Yet Recruiting
70
WSD MEDI
Warsaw, Poland, 02-786
Not Yet Recruiting
71
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Poland, 04-501
Not Yet Recruiting
72
ETG Zamość
Zamość, Poland, 22-400
Not Yet Recruiting
Research Team
T
There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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