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Recruiting Phase 3 NCT06937086

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

Phase 3 – large-scale trial before approval
Conditions: Ulcerative Colitis Obesity or Overweight

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Mirikizumab
DRUG
Mirikizumab
DRUG
Tirzepatide
DRUG
Placebo
DRUG
Locations 191
Austria (3)
Medizinische Universität Graz
Graz
Medizinische Universitaet Innsbruck
Innsbruck
NOT_YET_RECRUITING
Medizinische Universität Wien
Vienna
Belgium (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
Brazil (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
Bulgaria (3)
University Hospital "St. Ivan Rilski"
Gorna Oryahovitsa
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
Sofia
NOT_YET_RECRUITING
Medical Center Convex
Sofia
NOT_YET_RECRUITING
Canada (6)
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
Czech Republic (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
Denmark (6)
Aarhus Universitetshospital, Skejby
Aarhus
Rigshospitalet
Copenhagen
Herlev and Gentofte Hospital
Copenhagen
Aalborg Universitetshospital, Syd
Gistrup
Odense Universitetshospital
Odense
Vejle Sygehus
Vejle
France (10)
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
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez
CHU Rangueil
Toulouse
Clinique Pasteur
Toulouse
NOT_YET_RECRUITING
Germany (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
Greece (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
Hungary (4)
Semmelweis Egyetem
Budapest
Semmelweis Egyetem
Budapest
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged
CLINFAN Szolgáltató Kft
Szekszárd
Israel (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
Italy (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
Netherlands (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
Poland (12)
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice
Twoja Przychodnia Opolskie Centrum Medyczne
Opole
NOT_YET_RECRUITING
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
Romania (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
Slovakia (4)
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica
Cliniq s.r.o.
Bratislava
ENDOMED
Košice
Gastro LM
Prešov
Spain (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
Turkey (9)
Gazi University Health Research and Application Center Gazi Hospital
Ankara
NOT_YET_RECRUITING
Antalya Egitim ve Arastırma Hastanesi
Antalya
NOT_YET_RECRUITING
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
NOT_YET_RECRUITING
United Kingdom (4)
Southmead Hospital
Bristol
Ninewells Hospital and Medical School
Dundee
Royal Devon & Exeter Hospital
Exeter
Royal London Hospital
London
United States (37)
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
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
Icahn School of Medicine at Mount Sinai
New York , New York
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 Consultants of Southwest Virginia
Roanoke , Virginia
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
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
26.06.2025
Completion date
01.04.2028
Registry ID
NCT06937086
Source
clinicaltrials.gov
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