Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
- Conditions
- Crohn's DiseaseObesity or Overweight
- Interventions
- Registration Number
- NCT06937099
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 290
-
Have had a diagnosis of Crohn's disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria.
-
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 of these 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.
-
Have a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
-
Have an inadequate response to, loss of response to, or intolerance to:
- at least one conventional therapy (such as corticosteroids, oral azathioprine (AZA) or 60-mercaptopurine (6-MP), or oral aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, balsalazide) and/or,
- at least one advanced therapy for CD (defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies, anti-integrin antibodies, Janus kinase (JAK) inhibitors such as upadacitinib, or anti-interleukin (IL)-12p40 antibodies, for example, ustekinumab).
- 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, 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mirikizumab + Tirzepatide Mirikizumab Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC. Mirikizumab + Tirzepatide Tirzepatide Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC. Mirikizumab + Placebo Mirikizumab Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC. Mirikizumab + Placebo Placebo Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction Week 52 Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission Week 52 Percentage of participants who simultaneously achieve clinical remission by CDAI and endoscopic remission.
Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI Week 52 Percentage of participants who achieve maintenance of clinical remission by CDAI.
Percentage of Participants Who Achieved Maintenance of Endoscopic Remission Week 52 Percentage of participants who achieve maintenance of endoscopic remission.
Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight Week 52 Percentage of participants who achieve at least a 10% reduction in body weight.
Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline Week 52 Percentage of participants who achieve corticosteroid-free clinical remission by CDAI among participants who used corticosteroids at baseline.
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Baseline, Week 52 Change from baseline in inflammatory bowel disease questionnaire (IBDQ).
Trial Locations
- Locations (126)
California Medical Research Associates
🇺🇸Northridge, California, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Indiana University Health University Hospital
🇺🇸Indianapolis, Indiana, United States
Lucida Clinical Trials
🇺🇸New Bedford, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University Gastroenterology - Providence - West River Street
🇺🇸Providence, Rhode Island, United States
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Tirol, Austria
Medizinische Universität Wien
🇦🇹Vienna, Wien, Austria
Clinical Chc Montlégia
🇧🇪Liege, Liège, Belgium
AZORG Campus Aalst-Moorselbaan
🇧🇪Aalst, Oost-Vlaanderen, Belgium
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium
AZ Groeninge Campus Kennedylaan
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
🇧🇪Liège, Belgium
CEDOES
🇧🇷Vitória, Espírito Santo, Brazil
Fundação Universidade de Caxias do Sul (FUCS)
🇧🇷Caxias do sul, Rio Grande Do Sul, Brazil
NewData Clinical Research - Aracaju
🇧🇷Aracaju, Sergipe, Brazil
Loema Instituto de Pesquisa Clinica
🇧🇷Campinas, São Paulo, Brazil
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
Clínica Hepatogastro JK
🇧🇷São Paulo, Brazil
(G.I.R.I.) GI Research Institute Foundation
🇨🇦Vancouver, British Columbia, Canada
SurGal Clinic
🇨🇿Brno, Brno-město, Czechia
Nemocnice České Budějovice
🇨🇿České Budějovice, Jihočeský Kraj, Czechia
Krajská nemocnice Liberec
🇨🇿Turnov, Liberecký Kraj, Czechia
EndoArt
🇨🇿Ostrava, Moravskoslezský Kraj, Czechia
ResTrial GastroEndo s.r.o
🇨🇿Prague, Praha 4, Czechia
ISCARE klinické centrum
🇨🇿Prague, Praha 9, Czechia
Gastroenterologie
🇨🇿Hradec Králové, Czechia
Masarykova Nemocnice V Usti Nad Labem
🇨🇿Usti nad Labem, Ústí Nad Labem, Czechia
Rigshospitalet
🇩🇰Copenhagen, Hovedstaden, Denmark
Herlev and Gentofte Hospital
🇩🇰Copenhagen, Hovedstaden, Denmark
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Midtjylland, Denmark
Aalborg Universitetshospital, Syd
🇩🇰Aalborg, Nordjylland, Denmark
Vejle Sygehus
🇩🇰Vejle, Syddanmark, Denmark
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
🇫🇷Nice, Alpes-Maritimes, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
🇫🇷Marseille, Bouches-du-Rhône, France
Clinique Pasteur
🇫🇷Toulouse, Haute-Garonne, France
CHU Charles Nicolle
🇫🇷Rouen, Haute-Normandie, France
Clinique des Cèdres
🇫🇷Échirolles, Isère, France
Chu Saint Eloi
🇫🇷Montpellier, Languedoc-Roussillon, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, Paris, France
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
🇫🇷Montfermeil, Paris, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
🇫🇷Saint-Priest-en-Jarez, Rhône-Alpes, France
CHD Vendee
🇫🇷La Roche-sur-Yon, Vendée, France
Klinikum Ernst von Bergmann
🇩🇪Potsdam, Brandenburg, Germany
Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
🇩🇪Frankfurt am Main, Hessen, Germany
Universitätsklinikum Frankfurt Goethe-Universität
🇩🇪Frankfurt, Hessen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Praxiszentrum für Gastroenterologie
🇩🇪Grevenbroich, Nordrhein-Westfalen, Germany
Studiengesellschaft BSF Unternehmergesellschaft
🇩🇪Halle (Saale), Sachsen-Anhalt, Germany
Eugastro GmbH
🇩🇪Leipzig, Sachsen, Germany
Evangelismos General Hospital of Athens
🇬🇷Athens, Attikí, Greece
Thoracic General Hospital of Athens "I Sotiria"
🇬🇷Athens, Attikí, Greece
University Hospital of Ioannina
🇬🇷Ioannina, Ioánnina, Greece
Ippokrateio General Hospital of Thessaloniki
🇬🇷Thessaloniki, Kentrikí Makedonía, Greece
University General Hospital of Heraklion
🇬🇷Heraklion, Krítí, Greece
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád, Hungary
CLINFAN Szolgáltató Kft
🇭🇺Szekszárd, Tolna, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Assuta Ashdod Medical Center
🇮🇱Ashdod, HaDarom, Israel
Edith Wolfson Medical Center
🇮🇱Holon, HaMerkaz, Israel
Rabin Medical Center
🇮🇱Petah Tikva, HaMerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Yitzhak Shamir Medical Center
🇮🇱Zerifin, HaMerkaz, Israel
Rambam Health Care Campus
🇮🇱Haifa, HaTsafon, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Tell Abīb, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
🇮🇹Bologna, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
Humanitas
🇮🇹Rozzano, Lombardia, Italy
Ospedale Di Circolo
🇮🇹Rho, Milano, Italy
Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
🇮🇹Castellana Grotte, Puglia, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
🇮🇹Palermo, Sicilia, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Toscana, Italy
Azienda Ospedale - Università Padova
🇮🇹Padova, Veneto, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Boca Clinical Trials Mexico S.C.
🇲🇽Guadajalara, Jalisco, Mexico
Servicios de Oncología Médica Integral - Monterrey
🇲🇽Monterrey, Nuevo León, Mexico
Health Pharma Querétaro
🇲🇽Juriquilla, Querétaro, Mexico
Scientia Investigacion Clinica S.C.
🇲🇽Chihuahua, Mexico
Centro de Investigación Clinica Chapultepec
🇲🇽Mexico City, Mexico
Amsterdam UMC, locatie VUmc
🇳🇱Amsterdam, Noord-Holland, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Ikazia Ziekenhuis
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Melita Medical
🇵🇱Wroclaw, Dolnośląskie, Poland
Medrise Sp. z o.o.
🇵🇱Lublin, Lubelskie, Poland
ETG Zamość
🇵🇱Zamość, Lubelskie, Poland
NZOZ GynCentrum - Oddział Warszawa
🇵🇱Warsaw, Mazowieckie, Poland
Vivamed Sp. z o.o.
🇵🇱Warszawa, Mazowieckie, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
🇵🇱Warszawa, Mazowieckie, Poland
Korczowski Bartosz, Gabinet Lekarski
🇵🇱Rzeszów, Podkarpackie, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
🇵🇱Poznan, Wielkopolskie, Poland
Twoja Przychodnia PCM
🇵🇱Poznań, Wielkopolskie, Poland
Twoja Przychodnia SCM
🇵🇱Szczecin, Zachodniopomorskie, Poland
IRMED
🇵🇱Piotrkow Trybunalski, Łódzkie, Poland
Spitalul Județean de Urgență Bacău
🇷🇴Bacau, Bacău, Romania
Spitalul Clinic Colentina
🇷🇴Bucuresti, București, Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
🇷🇴Constanta, Constanța, Romania
Spitalul Clinic Județean de Urgență
🇷🇴Craiova, Dolj, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
🇷🇴Timisoara, Timiș, Romania
Spitalul Universitar de Urgență București
🇷🇴București, Romania
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
🇸🇰Banska Bystrica, Banskobystrický Kraj, Slovakia
Cliniq s.r.o.
🇸🇰Bratislava, Bratislavský Kraj, Slovakia
ENDOMED
🇸🇰Kosice, Košický Kraj, Slovakia
Gastro LM
🇸🇰Presov, Slovakia
Hospital de Cabueñes
🇪🇸Gijón, Asturias, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Centro Médico Teknon
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Galdakao-Usansolo
🇪🇸Galdakao, Bizkaia, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸València, Spain
Eskisehir Osmangazi University
🇹🇷Eskisehir, Eskişehir, Turkey
Kocaeli University Medical Faculty Hospital
🇹🇷Izmit, Kocaeli, Turkey
Antalya Egitim ve Arastırma Hastanesi
🇹🇷Antalya, Turkey
Uludag Universitesi
🇹🇷Bursa, Turkey
Mustafa Kemal Universitesi
🇹🇷Hatay, Turkey
Bezmialem Vakf Üniversitesi
🇹🇷Istanbul, Turkey
Ege Universitesi Hastanesi
🇹🇷İzmir, Turkey
Mersin University
🇹🇷Mersin, Turkey