Clinical trial
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Recruiting now · Phase 3 · 7 countries · Registry ID NCT06937099
Recruiting nowPhase 3Interventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionCrohn's Disease, Obesity or Overweight
Full registry criteria
Inclusion Criteria: * Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD * Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to \<30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions: * hypertension * Type 2 diabetes mellitus (T2DM) * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease. * Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline. * Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment. * Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline. * Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy Exclusion Criteria: * Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis. * Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum. * Currently have or are suspected to have an abscess. * Have a stoma, ileoanal pouch, or ostomy. * Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline. * Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM. * Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening. * Have had more than 5% body weight change in the past 3 months * Have a current or recent acute, active infection.
Treatments and study arms
Mirikizumab
Drug
Administered IV
Mirikizumab
Drug
Administered SC
Tirzepatide
Drug
Administered SC
Placebo
Drug
Administered SC
Primary outcomes
Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight ReductionWeek 52
Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.
Study locations
183 locations were listed when this page was built. The first 40 are shown.
Medizinische Universitaet Innsbruck🇦🇹 Innsbruck, Austria
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Robert KochPrincipal Investigator
Medizinische Universität Wien🇦🇹 Vienna, Austria
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Walter ReinischPrincipal Investigator
AZORG Campus Aalst-Moorselbaan🇧🇪 Aalst, Belgium
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Stijn Vanden BrandenPrincipal Investigator
Université Libre de Bruxelles - Hôpital Erasme🇧🇪 Brussels, Belgium
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Denis FranchimontPrincipal Investigator
AZ Groeninge Campus Kennedylaan🇧🇪 Kortrijk, Belgium
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Wouter Van MoerkerckePrincipal Investigator
UZ Leuven🇧🇪 Leuven, Belgium
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João Guedelha SabinoPrincipal Investigator
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman🇧🇪 Liège, Belgium
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Edouard LouisPrincipal Investigator
Clinical Chc Montlégia🇧🇪 Liège, Belgium
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Arnaud ColardPrincipal Investigator
NewData Clinical Research - Aracaju🇧🇷 Aracaju, Brazil
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Alex Callado FrançaPrincipal Investigator
L2IP - Instituto de Pesquisas Clínicas🇧🇷 Brasília, Brazil
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Luciana Teixeira de CamposPrincipal Investigator
Loema Instituto de Pesquisa Clinica🇧🇷 Campinas, Brazil
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Joaquim Simoes NetoPrincipal Investigator
Fundação Universidade de Caxias do Sul (FUCS)🇧🇷 Caxias do Sul, Brazil
Eduardo BrambillaPrincipal Investigator
Centro Digestivo de Curitiba🇧🇷 Curitiba, Brazil
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Odery Ramos JúniorPrincipal Investigator
Hospital de Clinicas de Porto Alegre🇧🇷 Porto Alegre, Brazil
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Luciana HarlacherPrincipal Investigator
Hospital de Clínicas de Ribeirão Preto🇧🇷 Ribeirão Preto, Brazil
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Rogerio ParraPrincipal Investigator
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição🇧🇷 Salvador, Brazil
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Genoile SilvaPrincipal Investigator
CEPIC - Centro Paulista de Investigação Clínica🇧🇷 São Paulo, Brazil
Renata LamannaPrincipal Investigator
CPQuali Pesquisa Clínica🇧🇷 São Paulo, Brazil
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Alexandre de Sousa CarlosPrincipal Investigator
Clínica Hepatogastro JK🇧🇷 São Paulo, Brazil
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Rodrigo Andrey RoccoPrincipal Investigator
CEDOES🇧🇷 Vitória, Brazil
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Felipe FerreiraPrincipal Investigator
Integral Pesquisa e Ensino🇧🇷 Votuporanga, Brazil
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HERLON VALÉRIOPrincipal Investigator
University Hospital "St. Ivan Rilski"🌐 Gorna Oryahovitsa, Bulgaria
Ilko KosturkovPrincipal Investigator
Gastroenterology and internal medicine research institute🇨🇦 Edmonton, Canada
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Allen LimPrincipal Investigator
London Health Sciences Centre🇨🇦 London, Canada
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Terry PonichPrincipal Investigator
Clinique IMD🇨🇦 Montreal, Canada
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Waqqas AfifPrincipal Investigator
(G.I.R.I.) GI Research Institute Foundation🇨🇦 Vancouver, Canada
Greg RosenfeldPrincipal Investigator
Gastroenterologie🇨🇿 Hradec Králové, Czechia
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Milan SirokyPrincipal Investigator
EndoArt🇨🇿 Ostrava, Czechia
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Radka KoskovaPrincipal Investigator
ISCARE klinické centrum🇨🇿 Prague, Czechia
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Milan LukasPrincipal Investigator
Masarykova Nemocnice V Usti Nad Labem🇨🇿 Ústí nad Labem, Czechia
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Michal TichyPrincipal Investigator
Herlev and Gentofte Hospital🇩🇰 Copenhagen, Denmark
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Jacob BjerrumPrincipal Investigator