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RECRUITING
NCT06937086
PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2025-06-26

Completion Date

2028-04

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DRUG

Mirikizumab

Administered IV

DRUG

Mirikizumab

Administered SC

DRUG

Tirzepatide

Administered SC

DRUG

Placebo

Administered SC

Locations (187)

Digestive Health Specialists

Dothan, Alabama, United States

Smart Cures Clinical Research

Anaheim, California, United States

Cedars-Sinai Medical Center

Beverly Hills, California, United States

United Medical Doctors - Los Alamitos

Los Alamitos, California, United States

California Medical Research Associates

Northridge, California, United States

Research Associates of South Florida - Miami - Southwest 8th Street

Miami, Florida, United States

Gastro Health Research - Miami

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

Digestive and Liver Center of Florida

Orlando, Florida, United States

Gastro Health Research - Pensacola

Pensacola, Florida, United States

Precision Clinical Research

Sunrise, Florida, United States

Grand Teton Research Group

Idaho Falls, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Gastroenterology Health Partners

New Albany, Indiana, United States

Gastroenterology Health Partners

Louisville, Kentucky, United States

Care Access - New Iberia

New Iberia, Louisiana, United States

Louisiana Research Center

Shreveport, Louisiana, United States

Capital Digestive Care - Chevy Chase

Chevy Chase, Maryland, United States

Lucida Clinical Trials

New Bedford, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

New York Gastroenterology Associates

New York, New York, United States

Care Access - Yonkers

Yonkers, New York, United States

Coastal Research Institute - Fayetteville

Fayetteville, North Carolina, United States

Gastro Intestinal Research Institute of Northern Ohio, LLC

Westlake, Ohio, United States

Thomas Jefferson University - Medicine/GI and Hepatology

Philadelphia, Pennsylvania, United States

University Gastroenterology

Providence, Rhode Island, United States

Gastroenterology Associates - Patewood

Greenville, South Carolina, United States

Gastroenterology Center Of The Midsouth

Cordova, Tennessee, United States

Gastroenterology Research of San Antonio

San Antonio, Texas, United States

Southern Star Research Institute

San Antonio, Texas, United States

Tyler Research Institute

Tyler, Texas, United States

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia, United States

Washington Gastroenterology - Tacoma

Tacoma, Washington, United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Medizinische Universität Graz

Graz, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Medizinische Universität Wien

Vienna, Austria

AZORG Campus Aalst-Moorselbaan

Aalst, Belgium

Université Libre de Bruxelles - Hôpital Erasme

Brussels, Belgium

AZ Groeninge Campus Kennedylaan

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium

Clinical Chc Montlégia

Liège, Belgium

NewData Clinical Research - Aracaju

Aracaju, Brazil

L2IP - Instituto de Pesquisas Clínicas

Brasília, Brazil

Loema Instituto de Pesquisa Clinica

Campinas, Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, Brazil

Centro Digestivo de Curitiba

Curitiba, Brazil

Galileo Medical Research

Juiz de Fora, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, Brazil

CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição

Salvador, Brazil

Pesquisare Saude

Santo André, Brazil

CPQuali Pesquisa Clínica

São Paulo, Brazil

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, Brazil

Clínica Hepatogastro JK

São Paulo, Brazil

CEDOES

Vitória, Brazil

Integral Pesquisa e Ensino

Votuporanga, Brazil

University Hospital "St. Ivan Rilski"

Gorna Oryahovitsa, Bulgaria

London Health Sciences Centre

London, Canada

London Digestive Disease Institute

London, Canada

Clinique IMD

Montreal, Canada

The Ottawa Hospital - General Campus

Ottawa, Canada

Vancouver General Hospital

Vancouver, Canada

(G.I.R.I.) GI Research Institute Foundation

Vancouver, Canada

SurGal Clinic

Brno, Czechia

Gastroenterologie

Hradec Králové, Czechia

EndoArt

Ostrava, Czechia

ResTrial GastroEndo s.r.o

Prague, Czechia

ISCARE klinické centrum

Prague, Czechia

Masarykova Nemocnice V Usti Nad Labem

Ústí nad Labem, Czechia

Aarhus Universitetshospital, Skejby

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Herlev and Gentofte Hospital

Copenhagen, Denmark

Aalborg Universitetshospital, Syd

Gistrup, Denmark

Odense Universitetshospital

Odense, Denmark

Vejle Sygehus

Vejle, Denmark

Clinique des Cèdres

Échirolles, France

CHD Vendee

La Roche-sur-Yon, France

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Chu Saint Eloi

Montpellier, France

Centres Médico Chirurgicaux - Clinique Ambroise Paré

Neuilly-sur-Seine, France

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, France

Hôpital Saint Antoine

Paris, France

Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord

Saint-Priest-en-Jarez, France

CHU Rangueil

Toulouse, France

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt, Germany

Praxiszentrum für Gastroenterologie

Grevenbroich, Germany

Studiengesellschaft Mitteldeutschland GmbH

Halle, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Eugastro GmbH

Leipzig, Germany

Klinikum Ernst von Bergmann

Potsdam, Germany

Evangelismos General Hospital of Athens

Athens, Greece

Thoracic General Hospital of Athens "I Sotiria"

Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, Greece

Semmelweis Egyetem

Budapest, Hungary

And 87 more locations on ClinicalTrials.gov