Clinical trial
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
Recruiting now · Phase 3 · 7 countries · Registry ID NCT06937086
Recruiting nowPhase 3Interventional
What this study is about
The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.
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
ConditionUlcerative Colitis, Obesity or Overweight
Full registry criteria
Inclusion Criteria: * Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline. * Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer. * Have obesity, \[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\] * Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions: * hypertension * Type 2 Diabetes Mellitus (T2DM) * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease. * Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab. Exclusion Criteria: * Have a current diagnosis of: * Crohn's disease * inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or * primary sclerosing cholangitis. * Have had or will need bowel resection or intestinal or intra-abdominal surgery. * Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope. * 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 a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening. * 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 and at Least 10% Weight ReductionWeek 52
Percentage of participants who simultaneously achieve clinical remission and at least 10% weight reduction.
Study locations
187 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
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Breno Balabem AlvesPrincipal 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
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