Actively Recruiting
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Led by Eli Lilly and Company · Updated on 2026-05-12
290
Participants Needed
187
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight. The maximum duration of this study is up to 61 weeks.
CONDITIONS
Official Title
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Crohn's disease or perianal fistulizing Crohn's disease
- Have obesity with a body mass index (BMI) of 30 kg/m2 or higher, or overweight with BMI between 27 and less than 30 kg/m2 plus at least one weight-related condition (hypertension, type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)
- Moderately to severely active Crohn's disease with a CDAI score of at least 220 at baseline
- Simple Endoscopic Score for Crohn's Disease (SES-CD) score of 6 or higher for ileal-colonic disease, or 4 or higher for isolated ileal disease within 21 days before the first dose
- If Crohn's disease has involved only or predominantly the colon for 8 years or more, negative tests for colorectal dysplasia and cancer within 1 year prior to baseline
- Inadequate response, loss of response, or intolerance to at least one specified conventional or advanced Crohn's disease therapy
You will not qualify if you...
- Current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified, or primary sclerosing cholangitis
- More than 2 missing segments among terminal ileum, right colon, transverse colon, left colon, and rectum
- Current or suspected abscess
- Presence of stoma, ileoanal pouch, or ostomy
- History of more than 3 small bowel resections, total small bowel resection greater than 100 cm, short bowel syndrome, or any intra-abdominal surgery within 3 months of baseline
- Diagnosis of type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus
- History of severe hypoglycemia or hypoglycemia unawareness within 6 months prior to screening
- More than 5% body weight change in the past 3 months
- Current or recent acute active infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 187 locations
1
Digestive Health Specialists
Dothan, Alabama, United States, 36301
Actively Recruiting
2
Smart Cures Clinical Research
Anaheim, California, United States, 92806
Actively Recruiting
3
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
Not Yet Recruiting
4
United Medical Doctors - Los Alamitos
Los Alamitos, California, United States, 90720
Actively Recruiting
5
California Medical Research Associates
Northridge, California, United States, 91324
Actively Recruiting
6
Research Associates of South Florida - Miami - Southwest 8th Street
Miami, Florida, United States, 33134
Actively Recruiting
7
Gastro Health Research - Miami
Miami, Florida, United States, 33176
Actively Recruiting
8
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
9
Digestive and Liver Center of Florida
Orlando, Florida, United States, 32825
Actively Recruiting
10
Gastro Health Research - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
11
Precision Clinical Research
Sunrise, Florida, United States, 33351
Actively Recruiting
12
Grand Teton Research Group
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
13
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not Yet Recruiting
14
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
15
Gastroenterology Health Partners
New Albany, Indiana, United States, 47150
Actively Recruiting
16
Gastroenterology Health Partners
Louisville, Kentucky, United States, 40218
Actively Recruiting
17
Care Access - New Iberia
New Iberia, Louisiana, United States, 70560
Actively Recruiting
18
Louisiana Research Center
Shreveport, Louisiana, United States, 71105
Actively Recruiting
19
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
20
Lucida Clinical Trials
New Bedford, Massachusetts, United States, 02740
Actively Recruiting
21
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
22
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
23
New York Gastroenterology Associates
New York, New York, United States, 10075
Actively Recruiting
24
Care Access - Yonkers
Yonkers, New York, United States, 10701
Actively Recruiting
25
Coastal Research Institute - Fayetteville
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
26
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, United States, 44145
Actively Recruiting
27
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
28
University Gastroenterology
Providence, Rhode Island, United States, 02905
Actively Recruiting
29
Gastroenterology Associates - Patewood
Greenville, South Carolina, United States, 29607
Actively Recruiting
30
Gastroenterology Center Of The Midsouth
Cordova, Tennessee, United States, 38018
Actively Recruiting
31
Gastroenterology Research of San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
32
Southern Star Research Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
33
Tyler Research Institute
Tyler, Texas, United States, 75701
Actively Recruiting
34
Washington Gastroenterology - Tacoma
Tacoma, Washington, United States, 98405
Actively Recruiting
35
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
36
Medizinische Universität Graz
Graz, Austria, 8036
Actively Recruiting
37
Medizinische Universitaet Innsbruck
Innsbruck, Austria, 6020
Not Yet Recruiting
38
Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
39
AZORG Campus Aalst-Moorselbaan
Aalst, Belgium, 9300
Actively Recruiting
40
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Belgium, 1070
Actively Recruiting
41
AZ Groeninge Campus Kennedylaan
Kortrijk, Belgium, 8500
Actively Recruiting
42
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
43
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium, 4000
Actively Recruiting
44
Clinical Chc Montlégia
Liège, Belgium, 4000
Actively Recruiting
45
NewData Clinical Research - Aracaju
Aracaju, Brazil, 49075-000
Actively Recruiting
46
L2IP - Instituto de Pesquisas Clínicas
Brasília, Brazil, 70200730
Not Yet Recruiting
47
Loema Instituto de Pesquisa Clinica
Campinas, Brazil, 13092-133
Actively Recruiting
48
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, Brazil, 95070-560
Actively Recruiting
49
Centro Digestivo de Curitiba
Curitiba, Brazil, 80430-180
Actively Recruiting
50
Galileo Medical Research
Juiz de Fora, Brazil, 36033-318
Actively Recruiting
51
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Actively Recruiting
52
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, Brazil, 14051-140
Actively Recruiting
53
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador, Brazil, 41500-300
Actively Recruiting
54
Pesquisare Saude
Santo André, Brazil, 09080-110
Actively Recruiting
55
CPQuali Pesquisa Clínica
São Paulo, Brazil, 01228-000
Actively Recruiting
56
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, Brazil, 04266-010
Actively Recruiting
57
Clínica Hepatogastro JK
São Paulo, Brazil, 04543-011
Actively Recruiting
58
CEDOES
Vitória, Brazil, 29055450
Actively Recruiting
59
Integral Pesquisa e Ensino
Votuporanga, Brazil, 15500-269
Actively Recruiting
60
University Hospital "St. Ivan Rilski"
Gorna Oryahovitsa, Bulgaria, 5100
Actively Recruiting
61
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
Sofia, Bulgaria, 1233
Not Yet Recruiting
62
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
Sofia, Bulgaria, 1527
Not Yet Recruiting
63
Gastroenterology and internal medicine research institute
Edmonton, Canada, T5R 1W2
Not Yet Recruiting
64
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London, Canada, N6A 5W9
Actively Recruiting
65
London Digestive Disease Institute
London, Canada, N6K 1M6
Actively Recruiting
66
Clinique IMD
Montreal, Canada, H3H 1E8
Actively Recruiting
67
The Ottawa Hospital - General Campus
Ottawa, Canada, K1H 8L6
Not Yet Recruiting
68
Vancouver General Hospital
Vancouver, Canada, V5Z 1M9
Not Yet Recruiting
69
(G.I.R.I.) GI Research Institute Foundation
Vancouver, Canada, V5Z 2K5
Not Yet Recruiting
70
SurGal Clinic
Brno, Czechia, 602 00
Actively Recruiting
71
Gastroenterologie
Hradec Králové, Czechia, 500 02
Actively Recruiting
72
EndoArt
Ostrava, Czechia, 710 00
Actively Recruiting
73
ResTrial GastroEndo s.r.o
Prague, Czechia, 143 00
Actively Recruiting
74
ISCARE klinické centrum
Prague, Czechia, 19000
Actively Recruiting
75
Masarykova Nemocnice V Usti Nad Labem
Ústí nad Labem, Czechia, 40113
Actively Recruiting
76
Aarhus Universitetshospital, Skejby
Aarhus, Denmark, 8200
Actively Recruiting
77
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
78
Herlev and Gentofte Hospital
Copenhagen, Denmark, 2730
Actively Recruiting
79
Aalborg Universitetshospital, Syd
Gistrup, Denmark, 9260
Actively Recruiting
80
Odense Universitetshospital
Odense, Denmark, 5000
Not Yet Recruiting
81
Vejle Sygehus
Vejle, Denmark, 7100
Actively Recruiting
82
Clinique des Cèdres
Échirolles, France, 38130
Actively Recruiting
83
CHD Vendee
La Roche-sur-Yon, France, 85000
Actively Recruiting
84
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
85
Chu Saint Eloi
Montpellier, France, 34295
Actively Recruiting
86
Centres Médico Chirurgicaux - Clinique Ambroise Paré
Neuilly-sur-Seine, France, 92200
Actively Recruiting
87
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, France, 06202
Actively Recruiting
88
Hôpital Saint Antoine
Paris, France, 75571
Actively Recruiting
89
CHU Charles Nicolle
Rouen, France, 76031
Actively Recruiting
90
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
91
CHU Rangueil
Toulouse, France, 31059
Actively Recruiting
92
Clinique Pasteur
Toulouse, France, 31076
Not Yet Recruiting
93
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, Germany, 60590
Actively Recruiting
94
Praxiszentrum für Gastroenterologie
Grevenbroich, Germany, 41515
Actively Recruiting
95
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Germany, 06108
Actively Recruiting
96
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
97
Eugastro GmbH
Leipzig, Germany, 04103
Actively Recruiting
98
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
Actively Recruiting
99
Evangelismos General Hospital of Athens
Athens, Greece, 106 76
Actively Recruiting
100
Thoracic General Hospital of Athens "I Sotiria"
Athens, Greece, 115 27
Actively Recruiting
101
University General Hospital of Heraklion
Heraklion, Greece, 711 10
Actively Recruiting
102
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Greece, 54642
Actively Recruiting
103
Semmelweis Egyetem
Budapest, Hungary, 1082
Actively Recruiting
104
Semmelweis Egyetem
Budapest, Hungary, 1088
Actively Recruiting
105
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary, 6725
Actively Recruiting
106
CLINFAN Szolgáltató Kft
Szekszárd, Hungary, 7100
Actively Recruiting
107
Assuta Ashdod Medical Center
Ashdod, Israel, 7747629
Actively Recruiting
108
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
109
Edith Wolfson Medical Center
Holon, Israel, 5810001
Actively Recruiting
110
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
111
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
112
Sheba Medical Center
Ramat Gan, Israel, 5262100
Actively Recruiting
113
Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
114
Yitzhak Shamir Medical Center
Ẕerifin, Israel, 7033001
Actively Recruiting
115
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Italy, 40138
Actively Recruiting
116
Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
Castellana Grotte, Italy, 70013
Actively Recruiting
117
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
118
Ospedale San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
119
Azienda Ospedale - Università Padova
Padova, Italy, 35128
Actively Recruiting
120
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
Palermo, Italy, 90146
Not Yet Recruiting
121
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Actively Recruiting
122
Ospedale Di Circolo
Rho, Italy, 20017
Actively Recruiting
123
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Actively Recruiting
124
Humanitas
Rozzano, Italy, 20089
Actively Recruiting
125
San Peregrino Unidad de Investigación
Aguascalientes, Mexico, 20230
Not Yet Recruiting
126
Scientia Investigacion Clinica S.C.
Chihuahua City, Mexico, 31207
Actively Recruiting
127
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, Mexico, 89440
Actively Recruiting
128
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, Mexico, 34000
Not Yet Recruiting
129
Boca Clinical Trials Mexico S.C.
Guadajalara, Mexico, 44600
Actively Recruiting
130
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara, Mexico, 44340
Not Yet Recruiting
131
Hospital General de Occidente
Guadalajara, Mexico, 45170
Not Yet Recruiting
132
Health Pharma Querétaro
Juriquilla, Mexico, 76230
Not Yet Recruiting
133
Centro de Investigación Clinica Chapultepec
Mexico City, Mexico, 04100
Not Yet Recruiting
134
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14080
Not Yet Recruiting
135
Medical Care and Research SA de CV
Mérida, Mexico, 97070
Actively Recruiting
136
Servicios de Oncología Médica Integral - Monterrey
Monterrey, Mexico, 66220
Actively Recruiting
137
Centro de Investigacion Clinica Chapultepec
Morelia, Mexico, 58260
Not Yet Recruiting
138
Boca Clinical Trials Mexico SC
Puebla City, Mexico, 72160
Not Yet Recruiting
139
Clinical Research Institute S.C.
Tlalnepantla, Mexico, 54055
Not Yet Recruiting
140
FAICIC S. de R.L. de C.V.
Veracruz, Mexico, 91900
Not Yet Recruiting
141
Amsterdam UMC, locatie VUmc
Amsterdam, Netherlands, 1081 HZ
Actively Recruiting
142
Radboudumc
Nijmegen, Netherlands, 6525 GA
Not Yet Recruiting
143
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
144
Ikazia Ziekenhuis
Rotterdam, Netherlands, 3083 AN
Actively Recruiting
145
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
146
Medrise Sp. z o.o.
Lublin, Poland, 20-582
Actively Recruiting
147
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, Poland, 45-819
Actively Recruiting
148
IRMED
Piotrkow Trybunalski, Poland, 97-300
Actively Recruiting
149
Twoja Przychodnia PCM
Poznan, Poland, 60-324
Actively Recruiting
150
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan, Poland, 60-354
Actively Recruiting
151
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland, 35-302
Actively Recruiting
152
Twoja Przychodnia SCM
Szczecin, Poland, 71-434
Actively Recruiting
153
NZOZ GynCentrum - Oddział Warszawa
Warsaw, Poland, 00-124
Actively Recruiting
154
Vivamed Sp. z o.o.
Warsaw, Poland, 03-580
Actively Recruiting
155
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Poland, 04-501
Actively Recruiting
156
Melita Medical
Wroclaw, Poland, 53-611
Actively Recruiting
157
ETG Zamość
Zamość, Poland, 22-400
Actively Recruiting
158
CMRC Headlands, LLC
San Juan, Puerto Rico, 00918
Actively Recruiting
159
Spitalul Județean de Urgență Bacău
Bacau, Romania, 600114
Actively Recruiting
160
Spitalul Clinic Colentina
Bucharest, Romania, 020125
Actively Recruiting
161
Spitalul Universitar de Urgență București
Bucharest, Romania, 050098
Actively Recruiting
162
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, Romania, 900591
Actively Recruiting
163
Spitalul Clinic Județean de Urgență
Craiova, Romania, 200642
Actively Recruiting
164
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, Romania, 300002
Actively Recruiting
165
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, Slovakia, 97517
Actively Recruiting
166
Cliniq s.r.o.
Bratislava, Slovakia, 81109
Actively Recruiting
167
ENDOMED
Košice, Slovakia, 040 13
Actively Recruiting
168
Gastro LM
Prešov, Slovakia, 080 01
Actively Recruiting
169
Centro Médico Teknon
Barcelona, Spain, 08022
Actively Recruiting
170
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
171
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide
Ferrol, Spain, 15405
Not Yet Recruiting
172
Hospital de Cabueñes
Gijón, Spain, 33394
Actively Recruiting
173
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28028
Actively Recruiting
174
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
175
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
176
Complejo Hospitalario de Navarra
Pamplona, Spain, 31009
Actively Recruiting
177
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
178
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
179
Gazi University Health Research and Application Center Gazi Hospital
Ankara, Turkey (Türkiye), 06560
Actively Recruiting
180
Uludag Universitesi
Bursa, Turkey (Türkiye), 16059
Actively Recruiting
181
Eskisehir Osmangazi University
Eskişehir, Turkey (Türkiye), 26480
Actively Recruiting
182
Mustafa Kemal Universitesi
Hatay, Turkey (Türkiye), 31030
Not Yet Recruiting
183
Bezmialem Vakf Üniversitesi
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
184
Ege Universitesi Hastanesi
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
185
Kocaeli University Medical Faculty Hospital
İzmit, Turkey (Türkiye), 41380
Actively Recruiting
186
Mersin University
Mersin, Turkey (Türkiye), 33110
Actively Recruiting
187
Antalya Egitim ve Arastırma Hastanesi
Muratpaşa, Turkey (Türkiye), 07050
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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