Clinical trial NCT06937099: Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
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 Crohn's Disease and Obesity or Overweight
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Crohn's Disease
Obesity or Overweight
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-04-22
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.

The maximum duration of this study is up to 61 weeks.


Eligibility criteria: Inclusion Criteria:

* Have had a diagnosis of Crohn's disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria.
* Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m2), or 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 moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
* Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.
* Have a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
* Have an inadequate response to, loss of response to, or intolerance to:

  * at least one conventional therapy (such as corticosteroids, oral azathioprine (AZA) or 60-mercaptopurine (6-MP), or oral aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, balsalazide) and/or,
  * at least one advanced therapy for CD (defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies, anti-integrin antibodies, Janus kinase (JAK) inhibitors such as upadacitinib, or anti-interleukin (IL)-12p40 antibodies, for example, ustekinumab).

Exclusion Criteria:

* Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
* Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.
* Currently have or are suspected to have an abscess.
* Have a stoma, ileoanal pouch, or ostomy.
* Have a history of more than 3 small bowel resections, diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
* 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 had more than 5% body weight change in the past 3 months
* Have a current or recent acute, active infection.

Primary outcomes:
measure: Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission
timeFrame: Week 52
measure: Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI
timeFrame: Week 52
measure: Percentage of Participants Who Achieved Maintenance of Endoscopic Remission
timeFrame: Week 52
measure: Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline
timeFrame: Week 52
measure: Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Baseline, Week 52
measure: Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight
timeFrame: Week 52
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists
state: Alabama
city: Northridge
country: United States
facility: California Medical Research Associates
state: California
city: Miami
country: United States
facility: Research Associates of South Florida - Miami - Southwest 8th Street
state: Florida
city: Miami
country: United States
facility: Gastro Health Research - Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Orlando
country: United States
facility: Digestive and Liver Center of Florida
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Idaho Falls
country: United States
facility: Grand Teton Research Group
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: New Albany
country: United States
facility: Gastroenterology Health Partners
state: Indiana
city: New Iberia
country: United States
facility: Care Access - New Iberia
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center
state: Louisiana
city: New Bedford
country: United States
facility: Lucida Clinical Trials
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Yonkers
country: United States
facility: Care Access - Yonkers
state: New York
city: Westlake
country: United States
facility: Gastro Intestinal Research Institute of Northern Ohio, LLC
state: Ohio
city: Providence
country: United States
facility: University Gastroenterology - Providence - West River Street
state: Rhode Island
city: Cordova
country: United States
facility: Gastroenterology Center Of The Midsouth
state: Tennessee
city: San Antonio
country: United States
facility: Southern Star Research Institute
state: Texas
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
state: Tirol
city: Vienna
country: Austria
facility: Medizinische Universität Wien
state: Wien
city: Brussels
country: Belgium
facility: Université Libre de Bruxelles - Hôpital Erasme
state: Bruxelles-Capitale, Région De
city: Liege
country: Belgium
facility: Clinical Chc Montlégia
state: Liège
city: Aalst
country: Belgium
facility: AZORG Campus Aalst-Moorselbaan
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Kennedylaan
state: West-Vlaanderen
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
city: Salvador
country: Brazil
facility: CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
state: Bahia
city: Brasília
country: Brazil
facility: L2IP - Instituto de Pesquisas Clínicas
state: Distrito Federal
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Juiz de Fora
country: Brazil
facility: Galileo Medical Research
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Centro Digestivo de Curitiba
state: Paraná
city: Caxias do sul
country: Brazil
facility: Fundação Universidade de Caxias do Sul (FUCS)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Aracaju
country: Brazil
facility: NewData Clinical Research - Aracaju
state: Sergipe
city: Campinas
country: Brazil
facility: Loema Instituto de Pesquisa Clinica
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital de Clínicas de Ribeirão Preto
state: São Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saude
state: São Paulo
city: Votuporanga
country: Brazil
facility: Integral Pesquisa e Ensino
state: São Paulo
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: São Paulo
country: Brazil
facility: Clínica Hepatogastro JK
city: Edmonton
country: Canada
facility: Gastroenterology and internal medicine research institute
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: (G.I.R.I.) GI Research Institute Foundation
state: British Columbia
city: London
country: Canada
facility: Victoria Hospital & Children's Hospital - London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Digestive Disease Institute
state: Ontario
city: Zagreb
country: Croatia
facility: Poliklinika Solmed
state: Grad Zagreb
city: Brno
country: Czechia
facility: SurGal Clinic
state: Brno-město
city: České Budějovice
country: Czechia
facility: Nemocnice České Budějovice
state: Jihočeský Kraj
city: Turnov
country: Czechia
facility: Krajská nemocnice Liberec
state: Liberecký Kraj
city: Ostrava
country: Czechia
facility: EndoArt
state: Moravskoslezský Kraj
city: Prague
country: Czechia
facility: ResTrial GastroEndo s.r.o
state: Praha 4
city: Prague
country: Czechia
facility: ISCARE klinické centrum
state: Praha 9
city: Hradec Králové
country: Czechia
facility: Gastroenterologie
city: Usti nad Labem
country: Czechia
facility: Masarykova Nemocnice V Usti Nad Labem
state: Ústí Nad Labem
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Hovedstaden
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Midtjylland
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd
state: Nordjylland
city: Vejle
country: Denmark
facility: Vejle Sygehus
state: Syddanmark
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
state: Alpes-Maritimes
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord
state: Bouches-du-Rhône
city: Toulouse cedex 9
country: France
facility: CHU Rangueil
state: Haute-Garonne
city: Toulouse
country: France
facility: Clinique Pasteur
state: Haute-Garonne
city: Rouen
country: France
facility: CHU Charles Nicolle
state: Haute-Normandie
city: Neuilly-sur-Seine
country: France
facility: Centres Médico Chirurgicaux - Clinique Ambroise Paré
state: Hauts-de-Seine
city: Échirolles
country: France
facility: Clinique des Cèdres
state: Isère
city: Montpellier
country: France
facility: Chu Saint Eloi
state: Languedoc-Roussillon
city: Le Kremlin-Bicêtre
country: France
facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
state: Paris
city: Montfermeil
country: France
facility: Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
state: Paris
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
state: Pays-de-la-Loire
city: Saint-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
state: Rhône-Alpes
city: La Roche-sur-Yon
country: France
facility: CHD Vendee
state: Vendée
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre
state: Hessen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt Goethe-Universität
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Grevenbroich
country: Germany
facility: Praxiszentrum für Gastroenterologie
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
facility: Studiengesellschaft BSF Unternehmergesellschaft
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Eugastro GmbH
state: Sachsen
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attikí
city: Athens
country: Greece
facility: Thoracic General Hospital of Athens "I Sotiria"
state: Attikí
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
state: Ioánnina
city: Thessaloniki
country: Greece
facility: Ippokrateio General Hospital of Thessaloniki
state: Kentrikí Makedonía
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Krítí
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
state: Csongrád
city: Szekszárd
country: Hungary
facility: CLINFAN Szolgáltató Kft
state: Tolna
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center
state: HaDarom
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
state: HaMerkaz
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center
state: HaMerkaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: HaTsafon
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Rozzano
country: Italy
facility: Humanitas
state: Lombardia
city: Rho
country: Italy
facility: Ospedale Di Circolo
state: Milano
city: Castellana Grotte
country: Italy
facility: Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"
state: Puglia
city: Palermo
country: Italy
facility: Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
state: Sicilia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedale - Università Padova
state: Veneto
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Guadajalara
country: Mexico
facility: Boca Clinical Trials Mexico S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital General de Occidente
state: Jalisco
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec
state: Michoacán
city: Monterrey
country: Mexico
facility: Servicios de Oncología Médica Integral - Monterrey
state: Nuevo León
city: Juriquilla
country: Mexico
facility: Health Pharma Querétaro
state: Querétaro
city: Ciudad Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
state: Tamaulipas
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatán
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica S.C.
city: Mexico City
country: Mexico
facility: Centro de Investigación Clinica Chapultepec
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Wroclaw
country: Poland
facility: Melita Medical
state: Dolnośląskie
city: Lublin
country: Poland
facility: Medrise Sp. z o.o.
state: Lubelskie
city: Zamość
country: Poland
facility: ETG Zamość
state: Lubelskie
city: Warsaw
country: Poland
facility: NZOZ GynCentrum - Oddział Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: Vivamed Sp. z o.o.
state: Mazowieckie
city: Warszawa
country: Poland
facility: Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
state: Mazowieckie
city: Rzeszów
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
state: Podkarpackie
city: Bialystok
country: Poland
facility: Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
state: Podlaskie
city: Poznan
country: Poland
facility: Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
state: Wielkopolskie
city: Poznań
country: Poland
facility: Twoja Przychodnia PCM
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia SCM
state: Zachodniopomorskie
city: Piotrkow Trybunalski
country: Poland
facility: IRMED
state: Łódzkie
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center
city: Bacau
country: Romania
facility: Spitalul Județean de Urgență Bacău
state: Bacău
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
state: București
city: Constanta
country: Romania
facility: Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
state: Constanța
city: Craiova
country: Romania
facility: Spitalul Clinic Județean de Urgență
state: Dolj
city: Timisoara
country: Romania
facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
state: Timiș
city: București
country: Romania
facility: Spitalul Universitar de Urgență București
city: Belgrade
country: Serbia
facility: University Medical Center "Bezanijska kosa"
state: Beograd
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
state: Banskobystrický Kraj
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
state: Bratislavský Kraj
city: Kosice
country: Slovakia
facility: ENDOMED
state: Košický Kraj
city: Presov
country: Slovakia
facility: Gastro LM
city: Gijón
country: Spain
facility: Hospital de Cabueñes
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Barcelona
country: Spain
facility: Centro Médico Teknon
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Bizkaia
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
state: Eskişehir
city: Izmit
country: Turkey
facility: Kocaeli University Medical Faculty Hospital
state: Kocaeli
city: Antalya
country: Turkey
facility: Antalya Egitim ve Arastırma Hastanesi
city: Bursa
country: Turkey
facility: Uludag Universitesi
city: Hatay
country: Turkey
facility: Mustafa Kemal Universitesi
city: Istanbul
country: Turkey
facility: Bezmialem Vakf Üniversitesi
city: İzmir
country: Turkey
facility: Ege Universitesi Hastanesi
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: Eli Lilly and Company
name: Contact Lilly at 1-800-LillyRx (1-800-545-5979)
role: STUDY_DIRECTOR
References: