A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight

Status: Recruiting
Location: See all (186) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Digestive Health Specialists
RECRUITING
Dothan
California
Smart Cures Clinical Research
RECRUITING
Anaheim
Cedars-Sinai Medical Center
NOT_YET_RECRUITING
Beverly Hills
United Medical Doctors - Los Alamitos
RECRUITING
Los Alamitos
California Medical Research Associates
RECRUITING
Northridge
Florida
Gastro Health Research - Miami
RECRUITING
Miami
Research Associates of South Florida - Miami - Southwest 8th Street
RECRUITING
Miami
Digestive and Liver Center of Florida
RECRUITING
Orlando
Orlando Health
NOT_YET_RECRUITING
Orlando
Gastro Health Research - Pensacola
NOT_YET_RECRUITING
Pensacola
Precision Clinical Research
RECRUITING
Sunrise
Idaho
Grand Teton Research Group
RECRUITING
Idaho Falls
Illinois
Rush University Medical Center
NOT_YET_RECRUITING
Chicago
Indiana
Indiana University Health University Hospital
NOT_YET_RECRUITING
Indianapolis
Gastroenterology Health Partners
RECRUITING
New Albany
Kentucky
Gastroenterology Health Partners
RECRUITING
Louisville
Louisiana
Care Access - New Iberia
RECRUITING
New Iberia
Louisiana Research Center
RECRUITING
Shreveport
Massachusetts
Lucida Clinical Trials
RECRUITING
New Bedford
Maryland
Capital Digestive Care - Chevy Chase
NOT_YET_RECRUITING
Chevy Chase
Missouri
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
North Carolina
Coastal Research Institute - Fayetteville
RECRUITING
Fayetteville
New Hampshire
Dartmouth-Hitchcock Medical Center
NOT_YET_RECRUITING
Lebanon
New York
Icahn School of Medicine at Mount Sinai
NOT_YET_RECRUITING
New York
New York Gastroenterology Associates
RECRUITING
New York
Care Access - Yonkers
RECRUITING
Yonkers
Ohio
Gastro Intestinal Research Institute of Northern Ohio, LLC
RECRUITING
Westlake
Pennsylvania
Thomas Jefferson University - Medicine/GI and Hepatology
NOT_YET_RECRUITING
Philadelphia
Rhode Island
University Gastroenterology - Providence - West River Street
RECRUITING
Providence
South Carolina
Gastroenterology Associates - Patewood
RECRUITING
Greenville
Tennessee
Gastroenterology Center Of The Midsouth
RECRUITING
Cordova
Texas
Gastroenterology Research of San Antonio
RECRUITING
San Antonio
Southern Star Research Institute
RECRUITING
San Antonio
Tyler Research Institute
RECRUITING
Tyler
Virginia
Gastroenterology Consultants of Southwest Virginia
NOT_YET_RECRUITING
Roanoke
Washington
Washington Gastroenterology - Tacoma
RECRUITING
Tacoma
Wisconsin
Wisconsin Center for Advanced Research
NOT_YET_RECRUITING
Milwaukee
Other Locations
Austria
Medizinische Universität Graz
NOT_YET_RECRUITING
Graz
Medizinische Universitaet Innsbruck
NOT_YET_RECRUITING
Innsbruck
Medizinische Universität Wien
NOT_YET_RECRUITING
Vienna
Belgium
AZORG Campus Aalst-Moorselbaan
NOT_YET_RECRUITING
Aalst
Université Libre de Bruxelles - Hôpital Erasme
NOT_YET_RECRUITING
Brussels
AZ Groeninge Campus Kennedylaan
NOT_YET_RECRUITING
Kortrijk
UZ Leuven
NOT_YET_RECRUITING
Leuven
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
NOT_YET_RECRUITING
Liège
Clinical Chc Montlégia
NOT_YET_RECRUITING
Liège
Brazil
NewData Clinical Research - Aracaju
NOT_YET_RECRUITING
Aracaju
L2IP - Instituto de Pesquisas Clínicas
NOT_YET_RECRUITING
Brasília
Loema Instituto de Pesquisa Clinica
NOT_YET_RECRUITING
Campinas
Fundação Universidade de Caxias do Sul (FUCS)
NOT_YET_RECRUITING
Caxias Do Sul
Centro Digestivo de Curitiba
NOT_YET_RECRUITING
Curitiba
Galileo Medical Research
NOT_YET_RECRUITING
Juiz De Fora
Hospital de Clinicas de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Hospital de Clínicas de Ribeirão Preto
NOT_YET_RECRUITING
Ribeirão Preto
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
NOT_YET_RECRUITING
Salvador
Pesquisare Saude
NOT_YET_RECRUITING
Santo André
CEPIC - Centro Paulista de Investigação Clínica
NOT_YET_RECRUITING
São Paulo
Clínica Hepatogastro JK
NOT_YET_RECRUITING
São Paulo
CPQuali Pesquisa Clínica
NOT_YET_RECRUITING
São Paulo
CEDOES
NOT_YET_RECRUITING
Vitória
Integral Pesquisa e Ensino
NOT_YET_RECRUITING
Votuporanga
Bulgaria
University Hospital St. Ivan Rilski
NOT_YET_RECRUITING
Gorna Oryahovitsa
2nd MHAT
NOT_YET_RECRUITING
Sofia
Medical Center Convex
NOT_YET_RECRUITING
Sofia
Canada
Gastroenterology and internal medicine research institute
NOT_YET_RECRUITING
Edmonton
London Digestive Disease Institute
NOT_YET_RECRUITING
London
Victoria Hospital & Children's Hospital - London Health Sciences Centre
NOT_YET_RECRUITING
London
Clinique IMD
NOT_YET_RECRUITING
Montreal
(G.I.R.I.) GI Research Institute Foundation
NOT_YET_RECRUITING
Vancouver
Vancouver General Hospital
NOT_YET_RECRUITING
Vancouver
Denmark
Aalborg Universitetshospital, Syd
NOT_YET_RECRUITING
Aalborg
Aarhus Universitetshospital, Skejby
NOT_YET_RECRUITING
Aarhus
Herlev and Gentofte Hospital
NOT_YET_RECRUITING
Copenhagen
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Odense Universitetshospital
NOT_YET_RECRUITING
Odense
Vejle Sygehus
NOT_YET_RECRUITING
Vejle
France
Clinique des Cèdres
NOT_YET_RECRUITING
Échirolles
CHD Vendee
NOT_YET_RECRUITING
La Roche-sur-yon
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
NOT_YET_RECRUITING
Le Kremlin-bicêtre
Chu Saint Eloi
NOT_YET_RECRUITING
Montpellier
Centres Médico Chirurgicaux - Clinique Ambroise Paré
NOT_YET_RECRUITING
Neuilly-sur-seine
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
NOT_YET_RECRUITING
Nice
Hôpital Saint Antoine
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
NOT_YET_RECRUITING
Saint-priest-en-jarez
CHU Rangueil
NOT_YET_RECRUITING
Toulouse
Clinique Pasteur
NOT_YET_RECRUITING
Toulouse
Germany
Universitätsklinikum Frankfurt Goethe-Universität
NOT_YET_RECRUITING
Frankfurt
Praxiszentrum für Gastroenterologie
NOT_YET_RECRUITING
Grevenbroich
Studiengesellschaft BSF Unternehmergesellschaft
RECRUITING
Halle
Medizinische Hochschule Hannover
NOT_YET_RECRUITING
Hanover
Eugastro GmbH
NOT_YET_RECRUITING
Leipzig
Klinikum Ernst von Bergmann
NOT_YET_RECRUITING
Potsdam
Greece
Evangelismos General Hospital of Athens
NOT_YET_RECRUITING
Athens
Thoracic General Hospital of Athens I Sotiria
NOT_YET_RECRUITING
Athens
University General Hospital of Heraklion
NOT_YET_RECRUITING
Heraklion
University Hospital of Ioannina
NOT_YET_RECRUITING
Ioannina
Ippokrateio General Hospital of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
Hungary
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
NOT_YET_RECRUITING
Szeged
CLINFAN Szolgáltató Kft
NOT_YET_RECRUITING
Szekszárd
Israel
Assuta Ashdod Medical Center
RECRUITING
Ashdod
Rambam Health Care Campus
RECRUITING
Haifa
Edith Wolfson Medical Center
NOT_YET_RECRUITING
Holon
Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Rabin Medical Center
NOT_YET_RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Yitzhak Shamir Medical Center
RECRUITING
Ẕerifin
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
NOT_YET_RECRUITING
Bologna
Ospedale Specializzato in Gastroenterologia Saverio de Bellis
NOT_YET_RECRUITING
Castellana Grotte
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Azienda Ospedale - Università Padova
NOT_YET_RECRUITING
Padua
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
NOT_YET_RECRUITING
Palermo
Azienda Ospedaliero Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Ospedale Di Circolo
NOT_YET_RECRUITING
Rho
Fondazione Policlinico Universitario Agostino Gemelli
NOT_YET_RECRUITING
Roma
Humanitas
NOT_YET_RECRUITING
Rozzano
Mexico
San Peregrino Unidad de Investigación
NOT_YET_RECRUITING
Aguascalientes
Scientia Investigacion Clinica S.C.
NOT_YET_RECRUITING
Chihuahua City
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
NOT_YET_RECRUITING
Ciudad Madero
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
NOT_YET_RECRUITING
Durango
Boca Clinical Trials Mexico S.C.
NOT_YET_RECRUITING
Guadajalara
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
NOT_YET_RECRUITING
Guadalajara
Hospital General de Occidente
NOT_YET_RECRUITING
Guadalajara
Health Pharma Querétaro
NOT_YET_RECRUITING
Juriquilla
Medical Care and Research SA de CV
NOT_YET_RECRUITING
Mérida
Centro de Investigación Clinica Chapultepec
NOT_YET_RECRUITING
Mexico City
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
NOT_YET_RECRUITING
Mexico City
Servicios de Oncología Médica Integral - Monterrey
NOT_YET_RECRUITING
Monterrey
Centro de Investigacion Clinica Chapultepec
NOT_YET_RECRUITING
Morelia
Boca Clinical Trials Mexico SC
NOT_YET_RECRUITING
Puebla City
Clinical Research Institute S.C.
NOT_YET_RECRUITING
Tlalnepantla
FAICIC S. de R.L. de C.V.
NOT_YET_RECRUITING
Veracruz
Netherlands
Amsterdam UMC, locatie VUmc
NOT_YET_RECRUITING
Amsterdam
Radboudumc
NOT_YET_RECRUITING
Nijmegen
Erasmus Medisch Centrum
NOT_YET_RECRUITING
Rotterdam
Ikazia Ziekenhuis
NOT_YET_RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht
NOT_YET_RECRUITING
Utrecht
Poland
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
NOT_YET_RECRUITING
Katowice
Twoja Przychodnia Opolskie Centrum Medyczne
NOT_YET_RECRUITING
Opole
IRMED
RECRUITING
Piotrkow Trybunalski
Twoja Przychodnia PCM
RECRUITING
Poznan
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
NOT_YET_RECRUITING
Poznan
Korczowski Bartosz, Gabinet Lekarski
NOT_YET_RECRUITING
Rzeszów
Twoja Przychodnia SCM
RECRUITING
Szczecin
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
NOT_YET_RECRUITING
Warsaw
NZOZ GynCentrum - Oddział Warszawa
NOT_YET_RECRUITING
Warsaw
Vivamed Sp. z o.o.
NOT_YET_RECRUITING
Warsaw
Melita Medical
NOT_YET_RECRUITING
Wroclaw
ETG Zamość
RECRUITING
Zamość
Puerto Rico
Caribbean Medical Research Center
RECRUITING
San Juan
Romania
Spitalul Județean de Urgență Bacău
NOT_YET_RECRUITING
Bacau
Spitalul Clinic Colentina
NOT_YET_RECRUITING
Bucharest
Spitalul Universitar de Urgență București
NOT_YET_RECRUITING
Bucharest
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
NOT_YET_RECRUITING
Constanța
Spitalul Clinic Județean de Urgență
NOT_YET_RECRUITING
Craiova
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
NOT_YET_RECRUITING
Timișoara
Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
RECRUITING
Banská Bystrica
Cliniq s.r.o.
RECRUITING
Bratislava
ENDOMED
NOT_YET_RECRUITING
Košice
Gastro LM
NOT_YET_RECRUITING
Prešov
Spain
Centro Médico Teknon
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Galdakao-Usansolo
NOT_YET_RECRUITING
Galdakao
Hospital de Cabueñes
NOT_YET_RECRUITING
Gijón
Hospital General Universitario Gregorio Marañon
SUSPENDED
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Central de Asturias
NOT_YET_RECRUITING
Oviedo
Complejo Hospitalario de Navarra
NOT_YET_RECRUITING
Pamplona
Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
NOT_YET_RECRUITING
Valencia
Turkey
Gazi University Health Research and Application Center Gazi Hospital
NOT_YET_RECRUITING
Ankara
Antalya Egitim ve Arastırma Hastanesi
NOT_YET_RECRUITING
Antalya
Uludag Universitesi
NOT_YET_RECRUITING
Bursa
Eskisehir Osmangazi University
NOT_YET_RECRUITING
Eskişehir
Mustafa Kemal Universitesi
NOT_YET_RECRUITING
Hatay
Bezmialem Vakf Üniversitesi
NOT_YET_RECRUITING
Istanbul
Ege Universitesi Hastanesi
NOT_YET_RECRUITING
Izmir
Kocaeli University Medical Faculty Hospital
NOT_YET_RECRUITING
İzmit
Mersin University
NOT_YET_RECRUITING
Mersin
United Kingdom
Southmead Hospital
NOT_YET_RECRUITING
Bristol
Ninewells Hospital and Medical School
NOT_YET_RECRUITING
Dundee
Royal Devon & Exeter Hospital
NOT_YET_RECRUITING
Exeter
Royal London Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2028-04
Participants
Target number of participants: 350
Treatments
Experimental: Mirikizumab + Tirzepatide
Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Experimental: Mirikizumab + Placebo
Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov