Език: EN EN
← Назад към резултатите
Набира участници Фаза 3 NCT06937099

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Фаза 3 – широко изпитване преди одобрение
Заболявания: Crohn's Disease Obesity or Overweight

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
Mirikizumab
DRUG
Mirikizumab
DRUG
Tirzepatide
DRUG
Placebo
DRUG
Места на провеждане 187
Австрия (3)
Medizinische Universität Graz
Graz
Medizinische Universitaet Innsbruck
Innsbruck
NOT_YET_RECRUITING
Medizinische Universität Wien
Vienna
Белгия (6)
AZORG Campus Aalst-Moorselbaan
Aalst
Université Libre de Bruxelles - Hôpital Erasme
Brussels
AZ Groeninge Campus Kennedylaan
Kortrijk
UZ Leuven
Leuven
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège
Clinical Chc Montlégia
Liège
Бразилия (15)
NewData Clinical Research - Aracaju
Aracaju
L2IP - Instituto de Pesquisas Clínicas
Brasília
NOT_YET_RECRUITING
Loema Instituto de Pesquisa Clinica
Campinas
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul
Centro Digestivo de Curitiba
Curitiba
Galileo Medical Research
Juiz de Fora
Hospital de Clinicas de Porto Alegre
Porto Alegre
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador
Pesquisare Saude
Santo André
CPQuali Pesquisa Clínica
São Paulo
CEPIC - Centro Paulista de Investigação Clínica
São Paulo
Clínica Hepatogastro JK
São Paulo
CEDOES
Vitória
Integral Pesquisa e Ensino
Votuporanga
България (3)
University Hospital "St. Ivan Rilski"
Gorna Oryahovitsa
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
Sofia
NOT_YET_RECRUITING
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
Sofia
NOT_YET_RECRUITING
Канада (7)
Gastroenterology and internal medicine research institute
Edmonton
NOT_YET_RECRUITING
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London
London Digestive Disease Institute
London
Clinique IMD
Montreal
The Ottawa Hospital - General Campus
Ottawa
NOT_YET_RECRUITING
Vancouver General Hospital
Vancouver
NOT_YET_RECRUITING
(G.I.R.I.) GI Research Institute Foundation
Vancouver
NOT_YET_RECRUITING
Чехия (6)
SurGal Clinic
Brno
Gastroenterologie
Hradec Králové
EndoArt
Ostrava
ResTrial GastroEndo s.r.o
Prague
ISCARE klinické centrum
Prague
Masarykova Nemocnice V Usti Nad Labem
Ústí nad Labem
Дания (6)
Aarhus Universitetshospital, Skejby
Aarhus
Rigshospitalet
Copenhagen
Herlev and Gentofte Hospital
Copenhagen
Aalborg Universitetshospital, Syd
Gistrup
Odense Universitetshospital
Odense
NOT_YET_RECRUITING
Vejle Sygehus
Vejle
Франция (11)
Clinique des Cèdres
Échirolles
CHD Vendee
La Roche-sur-Yon
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre
Chu Saint Eloi
Montpellier
Centres Médico Chirurgicaux - Clinique Ambroise Paré
Neuilly-sur-Seine
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice
Hôpital Saint Antoine
Paris
CHU Charles Nicolle
Rouen
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez
CHU Rangueil
Toulouse
Clinique Pasteur
Toulouse
NOT_YET_RECRUITING
Германия (6)
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt
Praxiszentrum für Gastroenterologie
Grevenbroich
Studiengesellschaft BSF Unternehmergesellschaft
Halle
Medizinische Hochschule Hannover
Hanover
Eugastro GmbH
Leipzig
Klinikum Ernst von Bergmann
Potsdam
Гърция (4)
Evangelismos General Hospital of Athens
Athens
Thoracic General Hospital of Athens "I Sotiria"
Athens
University General Hospital of Heraklion
Heraklion
Ippokrateio General Hospital of Thessaloniki
Thessaloniki
Унгария (4)
Semmelweis Egyetem
Budapest
Semmelweis Egyetem
Budapest
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged
CLINFAN Szolgáltató Kft
Szekszárd
Израел (8)
Assuta Ashdod Medical Center
Ashdod
Rambam Health Care Campus
Haifa
Edith Wolfson Medical Center
Holon
Shaare Zedek Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Sourasky Medical Center
Tel Aviv
Yitzhak Shamir Medical Center
Ẕerifin
Италия (10)
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna
Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
Castellana Grotte
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
Ospedale San Raffaele
Milan
NOT_YET_RECRUITING
Azienda Ospedale - Università Padova
Padova
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
Palermo
NOT_YET_RECRUITING
Azienda Ospedaliero Universitaria Pisana
Pisa
Ospedale Di Circolo
Rho
Fondazione Policlinico Universitario Agostino Gemelli
Roma
Humanitas
Rozzano
Mexico (16)
San Peregrino Unidad de Investigación
Aguascalientes
NOT_YET_RECRUITING
Scientia Investigacion Clinica S.C.
Chihuahua City
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango
NOT_YET_RECRUITING
Boca Clinical Trials Mexico S.C.
Guadajalara
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara
NOT_YET_RECRUITING
Hospital General de Occidente
Guadalajara
NOT_YET_RECRUITING
Health Pharma Querétaro
Juriquilla
NOT_YET_RECRUITING
Medical Care and Research SA de CV
Mérida
Centro de Investigación Clinica Chapultepec
Mexico City
NOT_YET_RECRUITING
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City
NOT_YET_RECRUITING
Servicios de Oncología Médica Integral - Monterrey
Monterrey
Centro de Investigacion Clinica Chapultepec
Morelia
NOT_YET_RECRUITING
Boca Clinical Trials Mexico SC
Puebla City
NOT_YET_RECRUITING
Clinical Research Institute S.C.
Tlalnepantla
NOT_YET_RECRUITING
FAICIC S. de R.L. de C.V.
Veracruz
NOT_YET_RECRUITING
Нидерландия (5)
Amsterdam UMC, locatie VUmc
Amsterdam
Radboudumc
Nijmegen
NOT_YET_RECRUITING
Erasmus Medisch Centrum
Rotterdam
NOT_YET_RECRUITING
Ikazia Ziekenhuis
Rotterdam
Universitair Medisch Centrum Utrecht
Utrecht
Полша (12)
Medrise Sp. z o.o.
Lublin
Twoja Przychodnia Opolskie Centrum Medyczne
Opole
IRMED
Piotrkow Trybunalski
Twoja Przychodnia PCM
Poznan
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan
NOT_YET_RECRUITING
Korczowski Bartosz, Gabinet Lekarski
Rzeszów
Twoja Przychodnia SCM
Szczecin
NZOZ GynCentrum - Oddział Warszawa
Warsaw
Vivamed Sp. z o.o.
Warsaw
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw
Melita Medical
Wroclaw
ETG Zamość
Zamość
Puerto Rico (1)
CMRC Headlands, LLC
San Juan
Румъния (6)
Spitalul Județean de Urgență Bacău
Bacau
Spitalul Clinic Colentina
Bucharest
Spitalul Universitar de Urgență București
Bucharest
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța
Spitalul Clinic Județean de Urgență
Craiova
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara
Словакия (4)
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica
Cliniq s.r.o.
Bratislava
ENDOMED
Košice
Gastro LM
Prešov
Испания (10)
Centro Médico Teknon
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide
Ferrol
NOT_YET_RECRUITING
Hospital de Cabueñes
Gijón
Hospital General Universitario Gregorio Marañon
Madrid
NOT_YET_RECRUITING
Hospital Universitario La Paz
Madrid
Hospital Universitario Central de Asturias
Oviedo
Complejo Hospitalario de Navarra
Pamplona
Hospital Universitario Virgen Macarena
Seville
Hospital Universitari i Politecnic La Fe
Valencia
Турция (9)
Gazi University Health Research and Application Center Gazi Hospital
Ankara
Uludag Universitesi
Bursa
Eskisehir Osmangazi University
Eskişehir
Mustafa Kemal Universitesi
Hatay
NOT_YET_RECRUITING
Bezmialem Vakf Üniversitesi
Istanbul
Ege Universitesi Hastanesi
Izmir
NOT_YET_RECRUITING
Kocaeli University Medical Faculty Hospital
İzmit
Mersin University
Mersin
Antalya Egitim ve Arastırma Hastanesi
Muratpaşa
NOT_YET_RECRUITING
САЩ (35)
Smart Cures Clinical Research
Anaheim , California
Cedars-Sinai Medical Center
Beverly Hills , California
NOT_YET_RECRUITING
Capital Digestive Care - Chevy Chase
Chevy Chase , Maryland
Rush University Medical Center
Chicago , Illinois
NOT_YET_RECRUITING
Gastroenterology Center Of The Midsouth
Cordova , Tennessee
Digestive Health Specialists
Dothan , Alabama
Coastal Research Institute - Fayetteville
Fayetteville , North Carolina
Gastroenterology Associates - Patewood
Greenville , South Carolina
Grand Teton Research Group
Idaho Falls , Idaho
Indiana University Health University Hospital
Indianapolis , Indiana
Dartmouth-Hitchcock Medical Center
Lebanon , New Hampshire
United Medical Doctors - Los Alamitos
Los Alamitos , California
Gastroenterology Health Partners
Louisville , Kentucky
Research Associates of South Florida - Miami - Southwest 8th Street
Miami , Florida
Gastro Health Research - Miami
Miami , Florida
Wisconsin Center for Advanced Research
Milwaukee , Wisconsin
Gastroenterology Health Partners
New Albany , Indiana
Lucida Clinical Trials
New Bedford , Massachusetts
Care Access - New Iberia
New Iberia , Louisiana
New York Gastroenterology Associates
New York , New York
California Medical Research Associates
Northridge , California
Orlando Health
Orlando , Florida
Digestive and Liver Center of Florida
Orlando , Florida
Gastro Health Research - Pensacola
Pensacola , Florida
Thomas Jefferson University - Medicine/GI and Hepatology
Philadelphia , Pennsylvania
University Gastroenterology - Providence - West River Street
Providence , Rhode Island
Gastroenterology Research of San Antonio
San Antonio , Texas
Southern Star Research Institute
San Antonio , Texas
Louisiana Research Center
Shreveport , Louisiana
Washington University School of Medicine
St Louis , Missouri
Precision Clinical Research
Sunrise , Florida
Washington Gastroenterology - Tacoma
Tacoma , Washington
Tyler Research Institute
Tyler , Texas
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake , Ohio
Care Access - Yonkers
Yonkers , New York
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
26.06.2025
Крайна дата
01.05.2028
Регистрационен номер
NCT06937099
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.