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NCT06937086PHASE3Recruiting

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

Eli Lilly and Company

Start Date

6/26/2025

Completion Date

4/1/2028

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 Criteria

Age Range: 18 years to 70 years

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

DRUG

Mirikizumab

DRUG

Mirikizumab

DRUG

Tirzepatide

DRUG

Placebo

Interested in This Trial?

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Conditions

Ulcerative ColitisObesity or Overweight

Locations

Digestive Health Specialists

Dothan, Alabama 36301

United States

Smart Cures Clinical Research

Anaheim, California 92806

United States

Cedars-Sinai Medical Center

Beverly Hills, California 90211

United States

United Medical Doctors - Los Alamitos

Los Alamitos, California 90720

United States

California Medical Research Associates

Northridge, California 91324

United States

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

Miami, Florida 33134

United States

Gastro Health Research - Miami

Miami, Florida 33176

United States

Orlando Health

Orlando, Florida 32806

United States

Digestive and Liver Center of Florida

Orlando, Florida 32825

United States

Gastro Health Research - Pensacola

Pensacola, Florida 32504

United States

Precision Clinical Research

Sunrise, Florida 33351

United States

Grand Teton Research Group

Idaho Falls, Idaho 83404

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Indiana University Health University Hospital

Indianapolis, Indiana 46202

United States

Gastroenterology Health Partners

New Albany, Indiana 47150

United States

Gastroenterology Health Partners

Louisville, Kentucky 40218

United States

Care Access - New Iberia

New Iberia, Louisiana 70560

United States

Louisiana Research Center

Shreveport, Louisiana 71105

United States

Capital Digestive Care - Chevy Chase

Chevy Chase, Maryland 20815

United States

Lucida Clinical Trials

New Bedford, Massachusetts 02740

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

New York Gastroenterology Associates

New York, New York 10075

United States

Care Access - Yonkers

Yonkers, New York 10701

United States

Coastal Research Institute - Fayetteville

Fayetteville, North Carolina 28304

United States

Gastro Intestinal Research Institute of Northern Ohio, LLC

Westlake, Ohio 44145

United States

Thomas Jefferson University - Medicine/GI and Hepatology

Philadelphia, Pennsylvania 19107

United States

University Gastroenterology

Providence, Rhode Island 02905

United States

Gastroenterology Associates - Patewood

Greenville, South Carolina 29607

United States

Gastroenterology Center Of The Midsouth

Cordova, Tennessee 38018

United States

Gastroenterology Research of San Antonio

San Antonio, Texas 78229

United States

Southern Star Research Institute

San Antonio, Texas 78229

United States

Tyler Research Institute

Tyler, Texas 75701

United States

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia 24014

United States

Washington Gastroenterology - Tacoma

Tacoma, Washington 98405

United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin 53215

United States

Medizinische Universität Graz

Graz, 8036

Austria

Medizinische Universitaet Innsbruck

Innsbruck, 6020

Austria

Medizinische Universität Wien

Vienna, 1090

Austria

AZORG Campus Aalst-Moorselbaan

Aalst, 9300

Belgium

Université Libre de Bruxelles - Hôpital Erasme

Brussels, 1070

Belgium

AZ Groeninge Campus Kennedylaan

Kortrijk, 8500

Belgium

UZ Leuven

Leuven, 3000

Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, 4000

Belgium

Clinical Chc Montlégia

Liège, 4000

Belgium

NewData Clinical Research - Aracaju

Aracaju, 49075-000

Brazil

L2IP - Instituto de Pesquisas Clínicas

Brasília, 70200730

Brazil

Loema Instituto de Pesquisa Clinica

Campinas, 13092-133

Brazil

Fundação Universidade de Caxias do Sul (FUCS)

Caxias do Sul, 95070-560

Brazil

Centro Digestivo de Curitiba

Curitiba, 80430-180

Brazil

Galileo Medical Research

Juiz de Fora, 36033-318

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90035-903

Brazil

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, 14051-140

Brazil

CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição

Salvador, 41500-300

Brazil

Pesquisare Saude

Santo André, 09080-110

Brazil

CPQuali Pesquisa Clínica

São Paulo, 01228-000

Brazil

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010

Brazil

Clínica Hepatogastro JK

São Paulo, 04543-011

Brazil

CEDOES

Vitória, 29055450

Brazil

Integral Pesquisa e Ensino

Votuporanga, 15500-269

Brazil

University Hospital "St. Ivan Rilski"

Gorna Oryahovitsa, 5100

Bulgaria

Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD

Sofia, 1233

Bulgaria

London Health Sciences Centre

London, N6A 5W9

Canada

London Digestive Disease Institute

London, N6K 1M6

Canada

Clinique IMD

Montreal, H3H 1E8

Canada

The Ottawa Hospital - General Campus

Ottawa, K1H 8L6

Canada

Vancouver General Hospital

Vancouver, V5Z 1M9

Canada

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

Vancouver, V5Z 2K5

Canada

SurGal Clinic

Brno, 602 00

Czechia

Gastroenterologie

Hradec Králové, 500 02

Czechia

EndoArt

Ostrava, 710 00

Czechia

ResTrial GastroEndo s.r.o

Prague, 143 00

Czechia

ISCARE klinické centrum

Prague, 19000

Czechia

Masarykova Nemocnice V Usti Nad Labem

Ústí nad Labem, 40113

Czechia

Aarhus Universitetshospital, Skejby

Aarhus, 8200

Denmark

Rigshospitalet

Copenhagen, 2100

Denmark

Herlev and Gentofte Hospital

Copenhagen, 2730

Denmark

Aalborg Universitetshospital, Syd

Gistrup, 9260

Denmark

Odense Universitetshospital

Odense, 5000

Denmark

Vejle Sygehus

Vejle, 7100

Denmark

Clinique des Cèdres

Échirolles, 38130

France

CHD Vendee

La Roche-sur-Yon, 85000

France

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270

France

Chu Saint Eloi

Montpellier, 34295

France

Centres Médico Chirurgicaux - Clinique Ambroise Paré

Neuilly-sur-Seine, 92200

France

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, 06202

France

Hôpital Saint Antoine

Paris, 75571

France

Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord

Saint-Priest-en-Jarez, 42270

France

CHU Rangueil

Toulouse, 31059

France

Clinique Pasteur

Toulouse, 31076

France

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt, 60590

Germany

Praxiszentrum für Gastroenterologie

Grevenbroich, 41515

Germany

Studiengesellschaft BSF Unternehmergesellschaft

Halle, 06108

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Eugastro GmbH

Leipzig, 04103

Germany

Klinikum Ernst von Bergmann

Potsdam, 14467

Germany

Evangelismos General Hospital of Athens

Athens, 106 76

Greece

Thoracic General Hospital of Athens "I Sotiria"

Athens, 115 27

Greece

University General Hospital of Heraklion

Heraklion, 711 10

Greece

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, 54642

Greece

Semmelweis Egyetem

Budapest, 1082

Hungary

Semmelweis Egyetem

Budapest, 1088

Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, 6725

Hungary

CLINFAN Szolgáltató Kft

Szekszárd, 7100

Hungary

Assuta Ashdod Medical Center

Ashdod, 7747629

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Edith Wolfson Medical Center

Holon, 5810001

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 5262100

Israel

Sourasky Medical Center

Tel Aviv, 6423906

Israel

Yitzhak Shamir Medical Center

Ẕerifin, 7033001

Israel

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, 40138

Italy

Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"

Castellana Grotte, 70013

Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Azienda Ospedale - Università Padova

Padova, 35128

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124

Italy

Ospedale Di Circolo

Rho, 20017

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Humanitas

Rozzano, 20089

Italy

San Peregrino Unidad de Investigación

Aguascalientes, 20230

Mexico

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207

Mexico

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.

Ciudad Madero, 89440

Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, 34000

Mexico

Boca Clinical Trials Mexico S.C.

Guadajalara, 44600

Mexico

Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

Guadalajara, 44340

Mexico

Hospital General de Occidente

Guadalajara, 45170

Mexico

Health Pharma Querétaro

Juriquilla, 76230

Mexico

Centro de Investigación Clinica Chapultepec

Mexico City, 04100

Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080

Mexico

Medical Care and Research SA de CV

Mérida, 97070

Mexico

Servicios de Oncología Médica Integral - Monterrey

Monterrey, 66220

Mexico

Centro de Investigacion Clinica Chapultepec

Morelia, 58260

Mexico

Boca Clinical Trials Mexico SC

Puebla City, 72160

Mexico

Clinical Research Institute S.C.

Tlalnepantla, 54055

Mexico

FAICIC S. de R.L. de C.V.

Veracruz, 91900

Mexico

Amsterdam UMC, locatie VUmc

Amsterdam, 1081 HZ

Netherlands

Radboudumc

Nijmegen, 6525 GA

Netherlands

Erasmus Medisch Centrum

Rotterdam, 3015 GD

Netherlands

Ikazia Ziekenhuis

Rotterdam, 3083 AN

Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX

Netherlands

Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero

Katowice, 40-600

Poland

Twoja Przychodnia Opolskie Centrum Medyczne

Opole, 45-819

Poland

IRMED

Piotrkow Trybunalski, 97-300

Poland

Twoja Przychodnia PCM

Poznan, 60-324

Poland

Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej

Poznan, 60-354

Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, 35-302

Poland

Twoja Przychodnia SCM

Szczecin, 71-434

Poland

NZOZ GynCentrum - Oddział Warszawa

Warsaw, 00-124

Poland

Vivamed Sp. z o.o.

Warsaw, 03-580

Poland

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, 04-501

Poland

Melita Medical

Wroclaw, 53-611

Poland

ETG Zamość

Zamość, 22-400

Poland

CMRC Headlands, LLC

San Juan, 00918

Puerto Rico

Spitalul Județean de Urgență Bacău

Bacau, 600114

Romania

Spitalul Clinic Colentina

Bucharest, 020125

Romania

Spitalul Universitar de Urgență București

Bucharest, 050098

Romania

Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

Constanța, 900591

Romania

Spitalul Clinic Județean de Urgență

Craiova, 200642

Romania

S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

Timișoara, 300002

Romania

Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

Banská Bystrica, 97517

Slovakia

Cliniq s.r.o.

Bratislava, 81109

Slovakia

ENDOMED

Košice, 040 13

Slovakia

Gastro LM

Prešov, 080 01

Slovakia

Centro Médico Teknon

Barcelona, 08022

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Arquitecto Marcide

Ferrol, 15405

Spain

Hospital de Cabueñes

Gijón, 33394

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28028

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Central de Asturias

Oviedo, 33011

Spain

Complejo Hospitalario de Navarra

Pamplona, 31009

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Gazi University Health Research and Application Center Gazi Hospital

Ankara, 06560

Turkey (Türkiye)

Antalya Egitim ve Arastırma Hastanesi

Antalya, 07100

Turkey (Türkiye)

Uludag Universitesi

Bursa, 16059

Turkey (Türkiye)

Eskisehir Osmangazi University

Eskişehir, 26480

Turkey (Türkiye)

Mustafa Kemal Universitesi

Hatay, 31030

Turkey (Türkiye)

Bezmialem Vakf Üniversitesi

Istanbul, 34093

Turkey (Türkiye)

Ege Universitesi Hastanesi

Izmir, 35100

Turkey (Türkiye)

Kocaeli University Medical Faculty Hospital

İzmit, 41380

Turkey (Türkiye)

Mersin University

Mersin, 33110

Turkey (Türkiye)

Southmead Hospital

Bristol, BS10 5NB

United Kingdom

Ninewells Hospital and Medical School

Dundee, DD1 9SY

United Kingdom

Royal Devon & Exeter Hospital

Exeter, EX2 5DW

United Kingdom

Royal London Hospital

London, E1 2AJ

United Kingdom