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

Not yet recruiting

• Conditions: Ulcerative Colitis; Obesity or Overweight
• Interventions: Drug: Mirikizumab; Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT06937086
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-18
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Study Start: 2025-06
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirikizumab + Tirzepatide	Mirikizumab	Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Mirikizumab + Tirzepatide	Tirzepatide	Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Mirikizumab + Placebo	Mirikizumab	Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Mirikizumab + Placebo	Placebo	Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction	Week 52	Percentage of participants who simultaneously achieve clinical remission and at least 10% weight reduction.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieve Clinical Remission	Week 24 and Week 52	Percentage of participants who achieve clinical remission.
Percentage of Participants Who Achieve Endoscopic Response	Week 24 and Week 52	Percentage of participants who achieve endoscopic response.
Percentage of Participants Who Achieve Mucosal Healing	Week 24 and Week 52	Percentage of participants who achieve mucosal healing.
Percentage of Participants Who Achieve Clinical Response	Week 24 and Week 52	Percentage of participants who achieve clinical response.
Percentage of Participants Who Achieve Endoscopic Remission	Week 24 and Week 52	Percentage of participants who achieve endoscopic remission.
Percentage of Participants Who Achieve Bowel Movement Urgency Improvement Captured with Urgency Numeric Rating Scale (NRS)	Week 24 and Week 52	The Urgency NRS is a patient-reported, single-item instrument that measures the severity for the urgency, sudden, or immediate need, to have a bowel movement in the past 24 hours using an 11 point NRS ranging from 0 "no urgency" to 10 "worst possible urgency"
Percentage of Participants Achieving Histologic Remission	Week 24 and Week 52	Percentage of participants achieving histologic remission.

Trial Locations

Locations (128)

California Medical Research Associates; 🇺🇸 Northridge, California, United States

Precision Clinical Research; 🇺🇸 Sunrise, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Indiana University Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Lucida Clinical Trials; 🇺🇸 New Bedford, Massachusetts, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University Gastroenterology - Providence - West River Street; 🇺🇸 Providence, Rhode Island, United States

Medizinische Universität Graz; 🇦🇹 Graz, Steiermark, Austria

Medizinische Universitaet Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria

Medizinische Universität Wien; 🇦🇹 Vienna, Wien, Austria

Clinical Chc Montlégia; 🇧🇪 Liege, Liège, Belgium

AZORG Campus Aalst-Moorselbaan; 🇧🇪 Aalst, Oost-Vlaanderen, Belgium

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

AZ Groeninge Campus Kennedylaan; 🇧🇪 Kortrijk, West-Vlaanderen, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman; 🇧🇪 Liège, Belgium

CEDOES; 🇧🇷 Vitória, Espírito Santo, Brazil

Fundação Universidade de Caxias do Sul (FUCS); 🇧🇷 Caxias do sul, Rio Grande Do Sul, Brazil

NewData Clinical Research - Aracaju; 🇧🇷 Aracaju, Sergipe, Brazil

Loema Instituto de Pesquisa Clinica; 🇧🇷 Campinas, São Paulo, Brazil

CPQuali Pesquisa Clínica; 🇧🇷 São Paulo, Brazil

Clínica Hepatogastro JK; 🇧🇷 São Paulo, Brazil

Bezmialem Vakf Üniversitesi; 🇹🇷 Istanbul, Turkey

(G.I.R.I.) GI Research Institute Foundation; 🇨🇦 Vancouver, British Columbia, Canada

SurGal Clinic; 🇨🇿 Brno, Brno-město, Czechia

Nemocnice České Budějovice; 🇨🇿 České Budějovice, Jihočeský Kraj, Czechia

Krajská nemocnice Liberec; 🇨🇿 Turnov, Liberecký Kraj, Czechia

EndoArt; 🇨🇿 Ostrava, Moravskoslezský Kraj, Czechia

ResTrial GastroEndo s.r.o; 🇨🇿 Prague, Praha 4, Czechia

ISCARE klinické centrum; 🇨🇿 Prague, Praha 9, Czechia

Gastroenterologie; 🇨🇿 Hradec Králové, Czechia

Masarykova Nemocnice V Usti Nad Labem; 🇨🇿 Usti nad Labem, Ústí Nad Labem, Czechia

Rigshospitalet; 🇩🇰 Copenhagen, Hovedstaden, Denmark

Herlev and Gentofte Hospital; 🇩🇰 Copenhagen, Hovedstaden, Denmark

Aarhus Universitetshospital, Skejby; 🇩🇰 Aarhus, Midtjylland, Denmark

Aalborg Universitetshospital, Syd; 🇩🇰 Aalborg, Nordjylland, Denmark

Odense Universitetshospital; 🇩🇰 Odense, Syddanmark, Denmark

Vejle Sygehus; 🇩🇰 Vejle, Syddanmark, Denmark

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet; 🇫🇷 Nice, Alpes-Maritimes, France

Assistance Publique Hôpitaux de Marseille - Hôpital Nord; 🇫🇷 Marseille, Bouches-du-Rhône, France

Clinique Pasteur; 🇫🇷 Toulouse, Haute-Garonne, France

Clinique des Cèdres; 🇫🇷 Échirolles, Isère, France

Chu Saint Eloi; 🇫🇷 Montpellier, Languedoc-Roussillon, France

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, Paris, France

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil; 🇫🇷 Montfermeil, Paris, France

Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord; 🇫🇷 Saint-Priest-en-Jarez, Rhône-Alpes, France

CHD Vendee; 🇫🇷 La Roche-sur-Yon, Vendée, France

Klinikum Ernst von Bergmann; 🇩🇪 Potsdam, Brandenburg, Germany

Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre; 🇩🇪 Frankfurt am Main, Hessen, Germany

Universitätsklinikum Frankfurt Goethe-Universität; 🇩🇪 Frankfurt, Hessen, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

Praxiszentrum für Gastroenterologie; 🇩🇪 Grevenbroich, Nordrhein-Westfalen, Germany

Studiengesellschaft BSF Unternehmergesellschaft; 🇩🇪 Halle (Saale), Sachsen-Anhalt, Germany

Eugastro GmbH; 🇩🇪 Leipzig, Sachsen, Germany

Evangelismos General Hospital of Athens; 🇬🇷 Athens, Attikí, Greece

Thoracic General Hospital of Athens "I Sotiria"; 🇬🇷 Athens, Attikí, Greece

University Hospital of Ioannina; 🇬🇷 Ioannina, Ioánnina, Greece

Ippokrateio General Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Kentrikí Makedonía, Greece

University General Hospital of Heraklion; 🇬🇷 Heraklion, Krítí, Greece

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; 🇭🇺 Szeged, Csongrád, Hungary

CLINFAN Szolgáltató Kft; 🇭🇺 Szekszárd, Tolna, Hungary

Semmelweis Egyetem; 🇭🇺 Budapest, Hungary

Assuta Ashdod Medical Center; 🇮🇱 Ashdod, HaDarom, Israel

Edith Wolfson Medical Center; 🇮🇱 Holon, HaMerkaz, Israel

Ege Universitesi Hastanesi; 🇹🇷 İzmir, Turkey

Rabin Medical Center; 🇮🇱 Petah Tikva, HaMerkaz, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, HaMerkaz, Israel

Yitzhak Shamir Medical Center; 🇮🇱 Zerifin, HaMerkaz, Israel

Rambam Health Care Campus; 🇮🇱 Haifa, HaTsafon, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Tell Abīb, Israel

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Yerushalayim, Israel

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola; 🇮🇹 Bologna, Emilia-Romagna, Italy

Fondazione Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, Lazio, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Lombardia, Italy

Humanitas; 🇮🇹 Rozzano, Lombardia, Italy

Ospedale Di Circolo; 🇮🇹 Rho, Milano, Italy

Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"; 🇮🇹 Castellana Grotte, Puglia, Italy

Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO; 🇮🇹 Palermo, Sicilia, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Toscana, Italy

Azienda Ospedale - Università Padova; 🇮🇹 Padova, Veneto, Italy

Ospedale San Raffaele; 🇮🇹 Milano, Italy

Boca Clinical Trials Mexico S.C.; 🇲🇽 Guadajalara, Jalisco, Mexico

Servicios de Oncología Médica Integral - Monterrey; 🇲🇽 Monterrey, Nuevo León, Mexico

Health Pharma Querétaro; 🇲🇽 Juriquilla, Querétaro, Mexico

Scientia Investigacion Clinica S.C.; 🇲🇽 Chihuahua, Mexico

Centro de Investigación Clinica Chapultepec; 🇲🇽 Mexico City, Mexico

Amsterdam UMC, locatie VUmc; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Ikazia Ziekenhuis; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Melita Medical; 🇵🇱 Wroclaw, Dolnośląskie, Poland

ETG Zamość; 🇵🇱 Zamość, Lubelskie, Poland

NZOZ GynCentrum - Oddział Warszawa; 🇵🇱 Warsaw, Mazowieckie, Poland

Vivamed Sp. z o.o.; 🇵🇱 Warszawa, Mazowieckie, Poland

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś; 🇵🇱 Warszawa, Mazowieckie, Poland

Korczowski Bartosz, Gabinet Lekarski; 🇵🇱 Rzeszów, Podkarpackie, Poland

Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej; 🇵🇱 Poznan, Wielkopolskie, Poland

Twoja Przychodnia PCM; 🇵🇱 Poznań, Wielkopolskie, Poland

Twoja Przychodnia SCM; 🇵🇱 Szczecin, Zachodniopomorskie, Poland

IRMED; 🇵🇱 Piotrkow Trybunalski, Łódzkie, Poland

Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero; 🇵🇱 Katowice, Śląskie, Poland

Spitalul Județean de Urgență Bacău; 🇷🇴 Bacau, Bacău, Romania

Spitalul Clinic Colentina; 🇷🇴 Bucuresti, București, Romania

Constanta County Emergency Clinical Hospital Sf.Ap.Andrei; 🇷🇴 Constanta, Constanța, Romania

Spitalul Clinic Județean de Urgență; 🇷🇴 Craiova, Dolj, Romania

S.C Centrul de Gastroenterologie Dr. Goldis S.R.L; 🇷🇴 Timisoara, Timiș, Romania

Spitalul Universitar de Urgență București; 🇷🇴 București, Romania

Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica; 🇸🇰 Banska Bystrica, Banskobystrický Kraj, Slovakia

Cliniq s.r.o.; 🇸🇰 Bratislava, Bratislavský Kraj, Slovakia

ENDOMED; 🇸🇰 Kosice, Košický Kraj, Slovakia

Gastro LM; 🇸🇰 Presov, Slovakia

Hospital de Cabueñes; 🇪🇸 Gijón, Asturias, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Centro Médico Teknon; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Hospital Galdakao-Usansolo; 🇪🇸 Galdakao, Bizkaia, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitari i Politecnic La Fe; 🇪🇸 València, Spain

Eskisehir Osmangazi University; 🇹🇷 Eskisehir, Eskişehir, Turkey

Kocaeli University Medical Faculty Hospital; 🇹🇷 Izmit, Kocaeli, Turkey

Antalya Egitim ve Arastırma Hastanesi; 🇹🇷 Antalya, Turkey

Uludag Universitesi; 🇹🇷 Bursa, Turkey

Mustafa Kemal Universitesi; 🇹🇷 Hatay, Turkey

Mersin University; 🇹🇷 Mersin, Turkey

Ninewells Hospital and Medical School; 🇬🇧 Dundee, Dundee City, United Kingdom

Royal London Hospital; 🇬🇧 London, England, United Kingdom