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

Last updated: April 18, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Ulcers

Colic

Treatment

Placebo

Tirzepatide

Mirikizumab

Clinical Study ID

NCT06937086
27280
I6T-MC-AMCD
2024-520209-38-00
  • Ages 18-70
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Have had an established diagnosis of UC for ≥3 months before baseline which includesendoscopic evidence of UC and a histopathology report that supports a diagnosis ofUC.

  • Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5to 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 hada surveillance colonoscopy completed within 1 year prior to baseline must havedocumented 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 ofthese 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 ofthe 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 responseto or a loss of response to, or are intolerant to advanced therapy for UC, definedas: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF)antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such astofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such asetrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example,ustekinumab.

Exclusion

Exclusion Criteria:

  • Have a current diagnosis of:

  • Crohn's disease

  • inflammatory bowel disease (IBD) unclassified (formerly known as indeterminatecolitis), 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 thatcannot 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 6months 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.

Study Design

Total Participants: 350
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 01, 2025
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • Medizinische Universität Graz

    Graz, Steiermark 8036
    Austria

    Site Not Available

  • Medizinische Universitaet Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Vienna, Wien 1090
    Austria

    Site Not Available

  • Clinical Chc Montlégia

    Liege, Liège 4000
    Belgium

    Site Not Available

  • AZORG Campus Aalst-Moorselbaan

    Aalst, Oost-Vlaanderen 9300
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, West-Vlaanderen 8500
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000
    Belgium

    Site Not Available

  • CEDOES

    Vitória, Espírito Santo 29055450
    Brazil

    Site Not Available

  • Fundação Universidade de Caxias do Sul (FUCS)

    Caxias do sul, Rio Grande Do Sul 95070-560
    Brazil

    Site Not Available

  • NewData Clinical Research - Aracaju

    Aracaju, Sergipe 49075-000
    Brazil

    Site Not Available

  • Loema Instituto de Pesquisa Clinica

    Campinas, São Paulo 13092-133
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • Clínica Hepatogastro JK

    São Paulo, 04543-011
    Brazil

    Site Not Available

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

    Vancouver, British Columbia V5Z 2K5
    Canada

    Site Not Available

  • SurGal Clinic

    Brno, Brno-město 602 00
    Czechia

    Site Not Available

  • Nemocnice České Budějovice

    České Budějovice, Jihočeský Kraj 370 01
    Czechia

    Site Not Available

  • Krajská nemocnice Liberec

    Turnov, Liberecký Kraj 51101
    Czechia

    Site Not Available

  • EndoArt

    Ostrava, Moravskoslezský Kraj 710 00
    Czechia

    Site Not Available

  • ResTrial GastroEndo s.r.o

    Prague, Praha 4 143 00
    Czechia

    Site Not Available

  • ISCARE klinické centrum

    Prague, Praha 9 19000
    Czechia

    Site Not Available

  • Masarykova Nemocnice V Usti Nad Labem

    Usti nad Labem, Ústí Nad Labem 40113
    Czechia

    Site Not Available

  • Gastroenterologie

    Hradec Králové, 500 02
    Czechia

    Site Not Available

  • Herlev and Gentofte Hospital

    Copenhagen, Hovedstaden 2730
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen, Hovedstaden 2100
    Denmark

    Site Not Available

  • Aarhus Universitetshospital, Skejby

    Aarhus, Midtjylland 8200
    Denmark

    Site Not Available

  • Aalborg Universitetshospital, Syd

    Aalborg, Nordjylland 9000
    Denmark

    Site Not Available

  • Odense Universitetshospital

    Odense, Syddanmark 5000
    Denmark

    Site Not Available

  • Vejle Sygehus

    Vejle, Syddanmark 7100
    Denmark

    Site Not Available

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, Alpes-Maritimes 06202
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord

    Marseille, Bouches-du-Rhône 13915
    France

    Site Not Available

  • Clinique Pasteur

    Toulouse, Haute-Garonne 31076
    France

    Site Not Available

  • Clinique des Cèdres

    Échirolles, Isère 38130
    France

    Site Not Available

  • Chu Saint Eloi

    Montpellier, Languedoc-Roussillon 34295
    France

    Site Not Available

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, Paris 94270
    France

    Site Not Available

  • Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

    Montfermeil, Paris 93370
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord

    Saint-Priest-en-Jarez, Rhône-Alpes 42270
    France

    Site Not Available

  • CHD Vendee

    La Roche-sur-Yon, Vendée 85000
    France

    Site Not Available

  • Klinikum Ernst von Bergmann

    Potsdam, Brandenburg 14467
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt Goethe-Universität

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre

    Frankfurt am Main, Hessen 60313
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Praxiszentrum für Gastroenterologie

    Grevenbroich, Nordrhein-Westfalen 41515
    Germany

    Site Not Available

  • Eugastro GmbH

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Studiengesellschaft BSF Unternehmergesellschaft

    Halle (Saale), Sachsen-Anhalt 06108
    Germany

    Site Not Available

  • Evangelismos General Hospital of Athens

    Athens, Attikí 106 76
    Greece

    Site Not Available

  • Thoracic General Hospital of Athens "I Sotiria"

    Athens, Attikí 115 27
    Greece

    Site Not Available

  • University Hospital of Ioannina

    Ioannina, Ioánnina 455 00
    Greece

    Site Not Available

  • Ippokrateio General Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía 54642
    Greece

    Site Not Available

  • University General Hospital of Heraklion

    Heraklion, Krítí 711 10
    Greece

    Site Not Available

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád 6725
    Hungary

    Site Not Available

  • CLINFAN Szolgáltató Kft

    Szekszárd, Tolna 7100
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

    Site Not Available

  • Assuta Ashdod Medical Center

    Ashdod, HaDarom 7747629
    Israel

    Site Not Available

  • Edith Wolfson Medical Center

    Holon, HaMerkaz 5810001
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva, HaMerkaz 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Zerifin, HaMerkaz 7033001
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, HaTsafon 3109601
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb 6423906
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9103102
    Israel

    Site Not Available

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

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • Humanitas

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • Ospedale Di Circolo

    Rho, Milano 20017
    Italy

    Site Not Available

  • Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"

    Castellana Grotte, Puglia 70013
    Italy

    Site Not Available

  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO

    Palermo, Sicilia 90146
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Toscana 56124
    Italy

    Site Not Available

  • Azienda Ospedale - Università Padova

    Padova, Veneto 35128
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Boca Clinical Trials Mexico S.C.

    Guadajalara, Jalisco 44600
    Mexico

    Site Not Available

  • Servicios de Oncología Médica Integral - Monterrey

    Monterrey, Nuevo León 66220
    Mexico

    Site Not Available

  • Health Pharma Querétaro

    Juriquilla, Querétaro 76230
    Mexico

    Site Not Available

  • Scientia Investigacion Clinica S.C.

    Chihuahua, 31207
    Mexico

    Site Not Available

  • Centro de Investigación Clinica Chapultepec

    Mexico City, 04100
    Mexico

    Site Not Available

  • Amsterdam UMC, locatie VUmc

    Amsterdam, Noord-Holland 1081 HZ
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, Zuid-Holland 3015 GD
    Netherlands

    Site Not Available

  • Ikazia Ziekenhuis

    Rotterdam, Zuid-Holland 3083 AN
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Melita Medical

    Wroclaw, Dolnośląskie 53-611
    Poland

    Site Not Available

  • ETG Zamość

    Zamość, Lubelskie 22-400
    Poland

    Site Not Available

  • NZOZ GynCentrum - Oddział Warszawa

    Warsaw, Mazowieckie 00-124
    Poland

    Site Not Available

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

    Warszawa, Mazowieckie 04-501
    Poland

    Site Not Available

  • Vivamed Sp. z o.o.

    Warszawa, Mazowieckie 03-580
    Poland

    Site Not Available

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, Podkarpackie 35-302
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej

    Poznan, Wielkopolskie 60-354
    Poland

    Site Not Available

  • Twoja Przychodnia PCM

    Poznań, Wielkopolskie 60-324
    Poland

    Site Not Available

  • Twoja Przychodnia SCM

    Szczecin, Zachodniopomorskie 71-434
    Poland

    Site Not Available

  • IRMED

    Piotrkow Trybunalski, Łódzkie 97-300
    Poland

    Site Not Available

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

    Katowice, Śląskie 40-600
    Poland

    Site Not Available

  • Spitalul Județean de Urgență Bacău

    Bacau, Bacău 600114
    Romania

    Site Not Available

  • Spitalul Clinic Colentina

    Bucuresti, București 020125
    Romania

    Site Not Available

  • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei

    Constanta, Constanța 900591
    Romania

    Site Not Available

  • Spitalul Clinic Județean de Urgență

    Craiova, Dolj 200642
    Romania

    Site Not Available

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

    Timisoara, Timiș 300002
    Romania

    Site Not Available

  • Spitalul Universitar de Urgență București

    București, 050098
    Romania

    Site Not Available

  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

    Banska Bystrica, Banskobystrický Kraj 97517
    Slovakia

    Site Not Available

  • Cliniq s.r.o.

    Bratislava, Bratislavský Kraj 81109
    Slovakia

    Site Not Available

  • ENDOMED

    Kosice, Košický Kraj 040 13
    Slovakia

    Site Not Available

  • Gastro LM

    Presov, 080 01
    Slovakia

    Site Not Available

  • Hospital de Cabueñes

    Gijón, Asturias 33394
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Centro Médico Teknon

    Barcelona, Barcelona [Barcelona] 08022
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Hospital Galdakao-Usansolo

    Galdakao, Bizkaia 48960
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona, Navarra 31009
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28028
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

  • Eskisehir Osmangazi University

    Eskisehir, Eskişehir 26480
    Turkey

    Site Not Available

  • Kocaeli University Medical Faculty Hospital

    Izmit, Kocaeli 41380
    Turkey

    Site Not Available

  • Antalya Egitim ve Arastırma Hastanesi

    Antalya, 07100
    Turkey

    Site Not Available

  • Uludag Universitesi

    Bursa, 16059
    Turkey

    Site Not Available

  • Mustafa Kemal Universitesi

    Hatay, 31030
    Turkey

    Site Not Available

  • Bezmialem Vakf Üniversitesi

    Istanbul, 34093
    Turkey

    Site Not Available

  • Mersin University

    Mersin, 33343
    Turkey

    Site Not Available

  • Ege Universitesi Hastanesi

    İzmir, 35100
    Turkey

    Site Not Available

  • Ninewells Hospital and Medical School

    Dundee, Dundee City DD1 9SY
    United Kingdom

    Site Not Available

  • Royal London Hospital

    London, England E1 2AJ
    United Kingdom

    Site Not Available

  • California Medical Research Associates

    Northridge, California 91324
    United States

    Site Not Available

  • Precision Clinical Research

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Indiana University Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Lucida Clinical Trials

    New Bedford, Massachusetts 02740
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University Gastroenterology - Providence - West River Street

    Providence, Rhode Island 02904
    United States

    Site Not Available

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