Clinical trial • Phase III • Gastroenterology

MIRIKIZUMAB for Ulcerative colitis | Obesity

Phase III trial of MIRIKIZUMAB for Ulcerative colitis | Obesity.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis | Obesity
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
30-04-2025
First CTIS Authorization Date
26-08-2025

Trial design

Randomised, mirikizumab concomitantly administered with tirzepatide (tirzepatide up to mtd 15 mg) versus mirikizumab and placebo (placebo to match tirzepatide). exact dosing schedules beyond tirzepatide 'up to 15 mg' are not specified in the available record.-controlled Phase III trial in Austria, Belgium, Bulgaria and others.

Randomised
Yes
Comparator
Mirikizumab concomitantly administered with Tirzepatide (Tirzepatide up to MTD 15 mg) versus Mirikizumab and placebo (placebo to match Tirzepatide). Exact dosing schedules beyond Tirzepatide 'up to 15 mg' are not specified in the available record.
Target Sample Size
150
Trial Duration For Participant
364

Eligibility

Recruits 150 No vulnerable populations selected (isVulnerablePopulationSelected: false). The trial population is described as adult participants; subject information and informed consent forms are provided (multiple ICF documents exist)..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). The trial population is described as adult participants; subject information and informed consent forms are provided (multiple ICF documents exist).

Inclusion criteria

  • {"criterion_text":"- Have been diagnosed with ulcerative colitis (UC) for at least 3 months before the start of the study, with tests confirming the diagnosis."}
  • {"criterion_text":"- Have moderately to severely active UC, with specific scores from medical tests confirming this within 21 days before the study starts."}
  • {"criterion_text":"- Have had a colonoscopy within the past year showing no signs of colorectal dysplasia or cancer, if you’ve had UC for 8 years or more."}
  • {"criterion_text":"- Be obese with a body mass index (BMI) of 30 or higher."}
  • {"criterion_text":"- Be obese, with a body mass index (BMI) of 30 or higher or be overweight with a BMI less than 30 but greater or equal to 27 and have at least one of the following conditions related to weight: high blood pressure, type 2 diabetes, abnormal cholesterol levels, sleep apnea (a condition where you stop breathing for short periods during sleep) or heart disease."}
  • {"criterion_text":"- Have tried and not responded well to at least one conventional UC medication (like oral corticosteroids or azathioprine) and/or also not responded well to advanced UC therapies (like biologics or JAK inhibitors)."}

Exclusion criteria

  • {"criterion_text":"- Have Crohn's disease, Unclassified inflammatory bowel disease (IBD) or Primary sclerosing cholangitis (a liver disease)."}
  • {"criterion_text":"- Have had or will need surgery on your intestines or abdomen."}
  • {"criterion_text":"- Have conditions like toxic megacolon, or narrowing in your intestines or colon."}
  • {"criterion_text":"- Have Type 1 diabetes or Type 2 diabetes treated with insulin."}
  • {"criterion_text":"- Have had severe low blood sugar or unawareness of low blood sugar in the past 6 months."}
  • {"criterion_text":"- Have had more than 5% body weight change in the past 3 months."}
  • {"criterion_text":"- Have a current or recent serious infection."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction","definition_or_measurement_approach":"Proportion (%) of participants who simultaneously achieve clinical remission and at least a 10% reduction in body weight; measured as the percentage of participants meeting both criteria."}

Recruitment

Digital Remote Recruitment
True, eConsent (IQVIA eConsent) with participant-facing landing pages and screenshots; digital advertising (social media videos, digital ads, search ads); remote retention/telehealth via ZoomHealth; use of digital eCOA (Atom5) and online patient messaging/databases.
Planned Sample Size
150
Recruitment Window Months
31
Consent Approach
Informed consent is via subject information and informed consent forms (multiple L1/L2 documents). eConsent is used (IQVIA eConsent materials, participant-facing screenshots and privacy policy are included). ICFs and related materials are available in multiple languages (examples in English, BEFR, BEDU, BG, GR, PL, HU, CZ and others). Separate materials include Pregnant Partner Informed Consent Form and study-specific participant materials; consent is provided by the adult participant (no assent/parental consent materials identified).

Methods

  • Site posters, flyers and brochures (multiple language/country versions referenced: ENG, BEFR, BEDU, BG, GR, PL, HU etc.).
  • Doctor referral letters and clinician outreach (documents titled 'Dr Referral Letter' / 'Doctor Referral Letter').
  • Digital advertising: social media videos, digital ad visuals and digital ad copy (documents: Social_Media_Video, Digital_Ad_Visuals, Digital_Ad_Copy).
  • Search engine advertising (documents referencing 'Search Ads').
  • Patient messaging and exclusive database messaging (documents reference 'IBD_Exclusive_Database_Messaging' and 'Patient_Messaging').
  • eConsent and patient-facing landing pages (IQVIA eConsent, participant-facing screenshots and landing page documents).
  • Site-based patient referral and middleware referral services (SiteRx, patient referral & recruitment services referenced).
  • Retention/remote visit support via telehealth platforms (ZoomHealth Terms of Service / Privacy Statement and screenshots referenced).
  • Country/language-specific recruitment materials and procedures (many K1/K2 documents are country-specific: BEFR/BEDU/GR/BG/PL/HU/NL etc.).

Geography

Total Number Of Sites
97
Total Number Of Participants
192

Austria

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
31-08-2025
Processing Time Days
6
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Principal Investigator Name
Walter Reinisch
Principal Investigator Email
walter.reinisch@meduniwien.ac.at
Contact Person Name
Walter Reinisch
Site Name
Medizinische Universitaet Innsbruck
Department Name
Internal Medicine 1
Principal Investigator Name
Robert Koch
Principal Investigator Email
Robert.Koch@i-med.ac.at
Contact Person Name
Robert Koch
Contact Person Email
Robert.Koch@i-med.ac.at
Site Name
Medical University of Graz
Department Name
Department of Internal Medicine, Division of Gastroenterology and Hepatology
Principal Investigator Name
Christoph Högenauer
Principal Investigator Email
christoph.hoegenauer@medunigraz.at
Contact Person Name
Christoph Högenauer

Belgium

Earliest CTIS Part Ii Submission Date
30-07-2025
Latest Decision Or Authorization Date
28-08-2025
Processing Time Days
29
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
AZORG Campus Aalst-Moorselbaan
Department Name
Gastroenterology
Principal Investigator Name
Stijn Vanden Branden
Principal Investigator Email
stijn.vanden.branden@olvz-aalst.be
Contact Person Name
Stijn Vanden Branden
Site Name
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Department Name
Gastroenterology Department
Principal Investigator Name
Edouard Louis
Principal Investigator Email
edouard.louis@uliege.be
Contact Person Name
Edouard Louis
Contact Person Email
edouard.louis@uliege.be
Site Name
UZ Leuven
Department Name
Gastroenterology - Inflammatory Bowel Disease
Principal Investigator Name
João Guedelha Sabino
Principal Investigator Email
joao.sabino@uzleuven.be
Contact Person Name
João Guedelha Sabino
Contact Person Email
joao.sabino@uzleuven.be
Site Name
AZ Groeninge Campus Kennedylaan
Department Name
gastroenterology
Principal Investigator Name
Wouter Van Moerkercke
Principal Investigator Email
wouter.vanmoerkercke@azgroeninge.be
Contact Person Name
Wouter Van Moerkercke
Site Name
CHC MontLegia
Department Name
Gastroenterology
Principal Investigator Name
Arnaud Colard
Principal Investigator Email
arnaud.colard@chc.be
Contact Person Name
Arnaud Colard
Contact Person Email
arnaud.colard@chc.be
Site Name
Université Libre de Bruxelles - Hôpital Erasme
Department Name
Clinical Research - Gastroenterology Department
Principal Investigator Name
Denis Franchimont
Principal Investigator Email
denis.franchimont@erasme.ulb.ac.be
Contact Person Name
Denis Franchimont

Bulgaria

Earliest CTIS Part Ii Submission Date
20-08-2025
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
19
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
First Internal Department
Principal Investigator Name
Ilko Kosturkov
Principal Investigator Email
ikosturkov@mcmedicaplus.com
Contact Person Name
Ilko Kosturkov
Contact Person Email
ikosturkov@mcmedicaplus.com
Site Name
Diagnostics And Consultation Center Convex Ltd.
Department Name
Gastroenterologist
Principal Investigator Name
Ludmila Tankova
Principal Investigator Email
drtankova@abv.bg
Contact Person Name
Ludmila Tankova
Contact Person Email
drtankova@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department Name
Gastroenterology
Principal Investigator Name
Nikolay Tsonev
Principal Investigator Email
dr.n.tsonev@abv.bg
Contact Person Name
Nikolay Tsonev
Contact Person Email
dr.n.tsonev@abv.bg

France

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
26-08-2025
Processing Time Days
75
Number Of Sites
10
Number Of Participants
17

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Unité de recherche clinique gastroentérologie et nutrition clinique
Principal Investigator Name
Stephane Schneider
Principal Investigator Email
schneider.s@chu-nice.fr
Contact Person Name
Stephane Schneider
Contact Person Email
schneider.s@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Service Gastro entérologie
Principal Investigator Name
Mathilde Barrau
Principal Investigator Email
mathilde.barrau@chu-st-etienne.fr
Contact Person Name
Mathilde Barrau
Site Name
Clinique Pasteur
Department Name
Gastro-hepato-entérologie
Principal Investigator Name
Patrick Faure
Principal Investigator Email
pfaure@clinique-pasteur.com
Contact Person Name
Patrick Faure
Contact Person Email
pfaure@clinique-pasteur.com
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Gastroenterology
Principal Investigator Name
Morgane Amil
Principal Investigator Email
morgane.amil@chd-vendee.fr
Contact Person Name
Morgane Amil
Contact Person Email
morgane.amil@chd-vendee.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
HGEA
Principal Investigator Name
Anne Bozon
Principal Investigator Email
aan-bozon@chu-montpellier.fr
Contact Person Name
Anne Bozon
Contact Person Email
aan-bozon@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
GASTROENTEROLOGY
Principal Investigator Name
Cyrielle Gilletta
Principal Investigator Email
gilletta.c@chu-toulouse.fr
Contact Person Name
Cyrielle Gilletta
Contact Person Email
gilletta.c@chu-toulouse.fr
Site Name
Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name
Institut des MICI
Principal Investigator Name
Xavier Treton
Principal Investigator Email
xavier.treton@institutdesmici.fr
Contact Person Name
Xavier Treton
Site Name
Clinique Des Cedres.
Department Name
MICI Institut Privé
Principal Investigator Name
Nicolas Mathieu
Principal Investigator Email
nicolas.mathieu@miciinstitutprive.com
Contact Person Name
Nicolas Mathieu
Site Name
Hopital Saint Antoine
Department Name
Gastroenterologie et nutrition
Principal Investigator Name
Julien Kirchgesner
Principal Investigator Email
julien.kirchgesner@aphp.fr
Contact Person Name
Julien Kirchgesner
Contact Person Email
julien.kirchgesner@aphp.fr
Site Name
Bicetre Hospital
Department Name
Hépato-gastroentérologie
Principal Investigator Name
Aurelien Amiot
Principal Investigator Email
aurelien.amiot@aphp.fr
Contact Person Name
Aurelien Amiot
Contact Person Email
aurelien.amiot@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
28-07-2025
Latest Decision Or Authorization Date
27-08-2025
Processing Time Days
30
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Principal Investigator Name
Lars Fechner
Principal Investigator Email
dr.fechner@gastro-halle.de
Contact Person Name
Lars Fechner
Contact Person Email
dr.fechner@gastro-halle.de
Site Name
Universitaetsklinikum Frankfurt AöR
Principal Investigator Name
Irina Blumenstein
Principal Investigator Email
irina.blumenstein@unimedizin-ffm.de
Contact Person Name
Irina Blumenstein
Site Name
Praxiszentrum für Gastroenterologie
Principal Investigator Name
Axel Naumann
Principal Investigator Email
naumann.axel@t-online.de
Contact Person Name
Axel Naumann
Contact Person Email
naumann.axel@t-online.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Gastroenterologie, Endokrinologie und Hepatologie - CED Ambulanz
Principal Investigator Name
Ursula Seidler
Principal Investigator Email
seidler.ursula@mh-hannover.de
Contact Person Name
Ursula Seidler
Contact Person Email
seidler.ursula@mh-hannover.de
Site Name
Eugastro GmbH
Principal Investigator Name
Ingolf Schiefke
Principal Investigator Email
ingolf.schiefke@eugastro.de
Contact Person Name
Ingolf Schiefke
Contact Person Email
ingolf.schiefke@eugastro.de
Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
Department of Gastroenterology, Hepatology, Infectious Diseases and Rheumatology
Principal Investigator Name
Daniel Baumgart
Principal Investigator Email
daniel.baumgart@uni-potsdam.de
Contact Person Name
Daniel Baumgart
Contact Person Email
daniel.baumgart@uni-potsdam.de

Greece

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
26-08-2025
Processing Time Days
12
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Evangelismos S.A.
Department Name
Department of Gastroenterology
Principal Investigator Name
Nikolaos Viazis
Principal Investigator Email
nikos.viazis@gmail.com
Contact Person Name
Nikolaos Viazis
Contact Person Email
nikos.viazis@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Internal Medicine Clinic, Gastroenterology Unit
Principal Investigator Name
Georgios Bamias
Principal Investigator Email
gbamias@gmail.com
Contact Person Name
Georgios Bamias
Contact Person Email
gbamias@gmail.com
Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
2nd Propaedeutic Internal Medicine Clinic, Department of Gastroenterology
Principal Investigator Name
Olga Giouleme
Principal Investigator Email
giouleme@auth.gr
Contact Person Name
Olga Giouleme
Contact Person Email
giouleme@auth.gr
Site Name
University General Hospital Of Ioannina
Department Name
Internal Medicine Sector, Gastroenterology Department
Principal Investigator Name
Konstantinos Katsanos
Principal Investigator Email
khkostas@hotmail.com
Contact Person Name
Konstantinos Katsanos
Contact Person Email
khkostas@hotmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Department of Gastroenterology
Principal Investigator Name
Ioannis Koutroubakis
Principal Investigator Email
ikoutroubakis@gmail.com
Contact Person Name
Ioannis Koutroubakis
Contact Person Email
ikoutroubakis@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
29-08-2025
Processing Time Days
53
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Semmelweis Egyetem
Department Name
Belgyógyászati és Hematológiai Klinika
Principal Investigator Name
Zsolt Tulassay
Principal Investigator Email
tulassay.zsolt@semmelweis.hu
Contact Person Name
Zsolt Tulassay
Contact Person Email
tulassay.zsolt@semmelweis.hu
Site Name
Clinfan Kft.
Department Name
Gasztroenterológiai Rendelő
Principal Investigator Name
Agnes Salamon
Principal Investigator Email
salamonagidr@gmail.com
Contact Person Name
Agnes Salamon
Contact Person Email
salamonagidr@gmail.com
Site Name
University Of Szeged
Department Name
Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika
Principal Investigator Name
Tamas Molnar
Principal Investigator Email
molnar.tamas@med.u-szeged.hu
Contact Person Name
Tamas Molnar
Contact Person Email
molnar.tamas@med.u-szeged.hu
Site Name
Semmelweis University
Department Name
Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
Principal Investigator Name
Pal Miheller
Principal Investigator Email
pmiheller@gmail.com
Contact Person Name
Pal Miheller
Contact Person Email
pmiheller@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
27-08-2025
Processing Time Days
34
Number Of Sites
10
Number Of Participants
13

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Gastroenterology and Endoscopy Unit
Principal Investigator Name
Flavio Caprioli
Principal Investigator Email
flavio.caprioli@unimi.it
Contact Person Name
Flavio Caprioli
Contact Person Email
flavio.caprioli@unimi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Dipartimento di Medicina Interna e Gastroenterologia
Principal Investigator Name
Franco Scaldaferri
Principal Investigator Email
franco.scaldaferri@policlinicogemelli.it
Contact Person Name
Franco Scaldaferri
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Gastroenterologia
Principal Investigator Name
Francesco Costa
Principal Investigator Email
fcosta@med.unipi.it
Contact Person Name
Francesco Costa
Contact Person Email
fcosta@med.unipi.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Gastroenterology and Gastrointestinal Endoscopy
Principal Investigator Name
Silvio Danese
Principal Investigator Email
ibd.trials@hsr.it
Contact Person Name
Silvio Danese
Contact Person Email
ibd.trials@hsr.it
Site Name
AOU Bologna Policlinico di Sant’Orsola
Department Name
SSD Malattie Infiammatorie Croniche Intestinali
Principal Investigator Name
Fernando Rizzello
Principal Investigator Email
fernando.rizzello@unibo.it
Contact Person Name
Fernando Rizzello
Contact Person Email
fernando.rizzello@unibo.it
Site Name
Universita Degli Studi Di Padova
Department Name
Surgery Oncology and Gastroenterology
Principal Investigator Name
Edoardo Savarino
Principal Investigator Email
edoardosavarino@gmail.com
Contact Person Name
Edoardo Savarino
Contact Person Email
edoardosavarino@gmail.com
Site Name
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
Department Name
Gastroenterology
Principal Investigator Name
Mauro Mastronardi
Principal Investigator Email
mauro21mastronardi@gmail.com
Contact Person Name
Mauro Mastronardi
Contact Person Email
mauro21mastronardi@gmail.com
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
U.O.S.D. Malattie Infiammatorie Croniche Intestinali (M.I.C.I)
Principal Investigator Name
Ambrogio Orlando
Principal Investigator Email
ambrogiorlando@gmail.com
Contact Person Name
Ambrogio Orlando
Contact Person Email
ambrogiorlando@gmail.com
Site Name
Humanitas Mirasole S.p.A.
Department Name
IBD center
Principal Investigator Name
Alessandro Armuzzi
Principal Investigator Email
clinicaltrialsibd@humanitas.it
Contact Person Name
Alessandro Armuzzi
Contact Person Email
clinicaltrialsibd@humanitas.it
Site Name
Azienda Socio Sanitaria Territoriale Rhodense
Department Name
U.O.C. di Gastroenterologia ed Endoscopia Digestiva
Principal Investigator Name
Simone Saibeni
Principal Investigator Email
saibo@tiscali.it
Contact Person Name
Simone Saibeni
Contact Person Email
saibo@tiscali.it

Romania

Earliest CTIS Part Ii Submission Date
31-07-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
32
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Spitalul Judetean De Urgenta Bacau
Department Name
Gastroenterology
Principal Investigator Name
Elena Luminita Popovici
Principal Investigator Email
elenaluminitapopovici@yahoo.com
Contact Person Name
Elena Luminita Popovici
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Gastroenterology
Principal Investigator Name
Radu Bogdan Mateescu
Principal Investigator Email
bogmateescu@gmail.com
Contact Person Name
Radu Bogdan Mateescu
Contact Person Email
bogmateescu@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Department Name
Gastroenterology
Principal Investigator Name
Eugen Dumitru
Principal Investigator Email
eugen.dumitru@yahoo.com
Contact Person Name
Eugen Dumitru
Contact Person Email
eugen.dumitru@yahoo.com
Site Name
Spitalul Universitar De Urgenta Bucuresti
Department Name
Gastroenterology
Principal Investigator Name
Lucian Negreanu
Principal Investigator Email
negreanu_99@yahoo.com
Contact Person Name
Lucian Negreanu
Contact Person Email
negreanu_99@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Craiova
Department Name
Gastroenterology
Principal Investigator Name
Dan Ionut Gheonea
Principal Investigator Email
digheonea@gmail.com
Contact Person Name
Dan Ionut Gheonea
Contact Person Email
digheonea@gmail.com
Site Name
Centrul De Gastroenterologie Dr. Goldis S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Adrian Eugen Goldis
Principal Investigator Email
goldisadi@yahoo.com
Contact Person Name
Adrian Eugen Goldis
Contact Person Email
goldisadi@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
27-08-2025
Processing Time Days
51
Number Of Sites
11
Number Of Participants
16

Sites

Site Name
Hospital De Galdakao Usansolo
Department Name
Digestive system
Principal Investigator Name
Iago Rodríguez-Lago
Principal Investigator Email
iago.r.lago@gmail.com
Contact Person Name
Iago Rodríguez-Lago
Contact Person Email
iago.r.lago@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Gastroenterology
Principal Investigator Name
Federico Argüelles-Arias
Principal Investigator Email
farguelles@telefonica.net
Contact Person Name
Federico Argüelles-Arias
Contact Person Email
farguelles@telefonica.net
Site Name
Area Sanitaria De Ferrol
Department Name
GASTROENTEROLOGY DEPARTMENT
Principal Investigator Name
Ana Echarri Piudo
Principal Investigator Email
ana.echarri.piudo@sergas.es
Contact Person Name
Ana Echarri Piudo
Contact Person Email
ana.echarri.piudo@sergas.es
Site Name
Hospital Universitario De Navarra
Department Name
Digestive system
Principal Investigator Name
Cristina Rodríguez Gutiérrez
Principal Investigator Email
cristina.rodriguez.gutierrez@navarra.es
Contact Person Name
Cristina Rodríguez Gutiérrez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Digestive system; Crohn's and Colitis Attention Unit
Principal Investigator Name
Natalia Borruel
Principal Investigator Email
natalia.borruel@vallhebron.cat
Contact Person Name
Natalia Borruel
Contact Person Email
natalia.borruel@vallhebron.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Digestive system
Principal Investigator Name
Ignacio Marin Jimenez
Principal Investigator Email
ignacio.marin@salud.madrid.org
Contact Person Name
Ignacio Marin Jimenez
Contact Person Email
ignacio.marin@salud.madrid.org
Site Name
Centro Medico Teknon-Grupo Quironsalud
Department Name
Digestive system; gastroenterology
Principal Investigator Name
Miquel Sans Cuffi
Principal Investigator Email
miquelsanscuffi@gmail.com
Contact Person Name
Miquel Sans Cuffi
Contact Person Email
miquelsanscuffi@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Digestive system; gastroenterology
Principal Investigator Name
Marisa Iborra Colomino
Principal Investigator Email
marisaiborra@hotmail.com
Contact Person Name
Marisa Iborra Colomino
Contact Person Email
marisaiborra@hotmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Digestive system
Principal Investigator Name
Ruth de Francisco
Principal Investigator Email
ruthdefrancisco@hotmail.com
Contact Person Name
Ruth de Francisco
Contact Person Email
ruthdefrancisco@hotmail.com
Site Name
Hospital Universitario De Cabuenes
Department Name
Digestive system
Principal Investigator Name
Pilar Varela Trastoy
Principal Investigator Email
trastoy@hotmail.com
Contact Person Name
Pilar Varela Trastoy
Contact Person Email
trastoy@hotmail.com
Site Name
Hospital Universitario La Paz
Department Name
Digestive system
Principal Investigator Name
María Dolores Martín Arranz
Principal Investigator Email
martinarranz.lapaz@gmail.com
Contact Person Name
María Dolores Martín Arranz
Contact Person Email
martinarranz.lapaz@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
13-08-2025
Latest Decision Or Authorization Date
29-08-2025
Processing Time Days
16
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Ikazia Ziekenhuis
Department Name
Gastroenterology - Hepatology
Principal Investigator Name
Geert Bezemer
Principal Investigator Email
g.bezemer@ikazia.nl
Contact Person Name
Geert Bezemer
Contact Person Email
g.bezemer@ikazia.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Gasteroenterology
Principal Investigator Name
Marjolijn Duijvestein
Principal Investigator Email
Marjolijn.Duijvestein@radboudumc.nl
Contact Person Name
Marjolijn Duijvestein
Site Name
Amsterdam UMC
Department Name
IBD trial Unit
Principal Investigator Name
Mark Lowenberg
Principal Investigator Email
m.lowenberg@amsterdamumc.nl
Contact Person Name
Mark Lowenberg
Contact Person Email
m.lowenberg@amsterdamumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Annemarie de Vries
Principal Investigator Email
a.c.devries@erasmusmc.nl
Contact Person Name
Annemarie de Vries
Contact Person Email
a.c.devries@erasmusmc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Gastro Enterology
Principal Investigator Name
Herma Fidder
Principal Investigator Email
h.h.fidder@umcutrecht.nl
Contact Person Name
Herma Fidder
Contact Person Email
h.h.fidder@umcutrecht.nl

Slovakia

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
39
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Cliniq s.r.o.
Department Name
Gastroenterology Department
Principal Investigator Name
Tibor Hlavaty
Principal Investigator Email
hlavaty.studie@cliniq.sk
Contact Person Name
Tibor Hlavaty
Contact Person Email
hlavaty.studie@cliniq.sk
Site Name
F D Roosevelt University General Hospital Of Banska Bystrica
Department Name
gastroenterologická ambulancia
Principal Investigator Name
Josef Balaz
Principal Investigator Email
balaz78@gmail.com
Contact Person Name
Josef Balaz
Contact Person Email
balaz78@gmail.com
Site Name
Endomed s.r.o.
Principal Investigator Name
Miroslav Fedurco
Principal Investigator Email
fedurco@endomed.sk
Contact Person Name
Miroslav Fedurco
Contact Person Email
fedurco@endomed.sk
Site Name
Gastro LM s.r.o.
Principal Investigator Name
Lubomir Mihalkanin
Principal Investigator Email
mihalkanin@gmail.com
Contact Person Name
Lubomir Mihalkanin
Contact Person Email
mihalkanin@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
30-07-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
33
Number Of Sites
12
Number Of Participants
34

Sites

Site Name
Gyncentrum Sp. z o.o.
Principal Investigator Name
Marek Olakowski
Principal Investigator Email
m.olakowski@holsaclinical.com
Contact Person Name
Marek Olakowski
Contact Person Email
m.olakowski@holsaclinical.com
Site Name
Twoja Przychodnia Opolskie Centrum Medyczne
Principal Investigator Name
Andrzej Jeznach
Principal Investigator Email
ajeznach@opolemed.com
Contact Person Name
Andrzej Jeznach
Contact Person Email
ajeznach@opolemed.com
Site Name
Vivamed Sp. z o.o.
Principal Investigator Name
Jakub Słowik
Principal Investigator Email
jakub.slowik@vivamed.com.pl
Contact Person Name
Jakub Słowik
Contact Person Email
jakub.slowik@vivamed.com.pl
Site Name
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Ewa Furmanowska-Ladorska
Principal Investigator Email
furmanowska@twojaprzychodnia.com
Contact Person Name
Ewa Furmanowska-Ladorska
Site Name
Etg Zamosc Sp. z o.o.
Principal Investigator Name
Katarzyna Wojcik
Principal Investigator Email
k.wojcik@etg-network.com
Contact Person Name
Katarzyna Wojcik
Contact Person Email
k.wojcik@etg-network.com
Site Name
Gyncentrum Sp. z o.o. (Warsaw address)
Principal Investigator Name
Anna Stolarska-Polchlopek
Principal Investigator Email
a.stolarska-polchlopek@holsaclinical.com
Contact Person Name
Anna Stolarska-Polchlopek
Site Name
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
Principal Investigator Name
Piotr Eder
Principal Investigator Email
piotreder@ump.edu.pl
Contact Person Name
Piotr Eder
Contact Person Email
piotreder@ump.edu.pl
Site Name
Melita Medical Sp. z o.o.
Principal Investigator Name
Jaroslaw Leszczyszyn
Principal Investigator Email
j.leszczyszyn@melitamedical.pl
Contact Person Name
Jaroslaw Leszczyszyn
Contact Person Email
j.leszczyszyn@melitamedical.pl
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Beata Gawdis-Wojnarska
Principal Investigator Email
gawdis@twojaprzychodnia.com
Contact Person Name
Beata Gawdis-Wojnarska
Contact Person Email
gawdis@twojaprzychodnia.com
Site Name
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
Principal Investigator Name
Katarzyna Ostrowska
Principal Investigator Email
gastrolog1@ir-med.pl
Contact Person Name
Katarzyna Ostrowska
Contact Person Email
gastrolog1@ir-med.pl
Site Name
Medical Network Sp. z o.o.
Principal Investigator Name
Jaroslaw Kierkus
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@med-net.pl
Site Name
Korczowski Bartosz, Gabinet Lekarski
Principal Investigator Name
Bartosz Korczowski
Principal Investigator Email
korczowski@op.pl
Contact Person Name
Bartosz Korczowski
Contact Person Email
korczowski@op.pl

Czechia

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
27-08-2025
Processing Time Days
76
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
ResTrial GastroEndo s.r.o.
Department Name
Gastroenterologie
Principal Investigator Name
Luděk Hrdlička
Principal Investigator Email
ludek.hrdlicka@restrial.com
Contact Person Name
Luděk Hrdlička
Contact Person Email
ludek.hrdlicka@restrial.com
Site Name
EndoArt s.r.o.
Principal Investigator Name
Radka Košková
Principal Investigator Email
mudr.koskova@seznam.cz
Contact Person Name
Radka Košková
Contact Person Email
mudr.koskova@seznam.cz
Site Name
Krajska zdravotni a.s.
Department Name
Oddělení gastroenterologie
Principal Investigator Name
Michal Tichý
Principal Investigator Email
michal.tichy@kzcr.eu
Contact Person Name
Michal Tichý
Contact Person Email
michal.tichy@kzcr.eu
Site Name
SurGal Clinic s.r.o.
Principal Investigator Name
Jan Ulbrych
Principal Investigator Email
jan.ulbrych@fnusa.cz
Contact Person Name
Jan Ulbrych
Contact Person Email
jan.ulbrych@fnusa.cz
Site Name
Iscare a.s.
Department Name
Klinické a výzkumné centrum pro střevní záněty
Principal Investigator Name
Milan Lukáš
Principal Investigator Email
studie.lukas@email.cz
Contact Person Name
Milan Lukáš
Contact Person Email
studie.lukas@email.cz
Site Name
Gastroenterologie s.r.o.
Principal Investigator Name
Milan Široký
Principal Investigator Email
m.sirokydr@gmail.com
Contact Person Name
Milan Široký
Contact Person Email
m.sirokydr@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
19-08-2025
Latest Decision Or Authorization Date
26-08-2025
Processing Time Days
7
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Aalborg University Hospital
Department Name
Department of Medical Gastroenterology
Principal Investigator Name
Jan Fallingborg
Principal Investigator Email
jaf@rn.dk
Contact Person Name
Jan Fallingborg
Contact Person Email
jaf@rn.dk
Site Name
Herlev Hospital
Department Name
Mave, - tarm og leversygdomme
Principal Investigator Name
Jacob Wium Bjerrum
Principal Investigator Email
Jacob.Wium.bjerrum@regionh.dk
Contact Person Name
Jacob Wium Bjerrum
Contact Person Email
Jacob.Wium.bjerrum@regionh.dk
Site Name
Lillebaelt Hospital
Department Name
Department of Internal Medicine, Section of Gastroenterology
Principal Investigator Name
Maiken Thyregod Jørgensen
Principal Investigator Email
maiken.t.joergensen@rsyd.dk
Contact Person Name
Maiken Thyregod Jørgensen
Contact Person Email
maiken.t.joergensen@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department of Digestive Diseases, Transplantation and General Surgery
Principal Investigator Name
Anja Poulsen
Principal Investigator Email
anja.poulsen@regionh.dk
Contact Person Name
Anja Poulsen
Contact Person Email
anja.poulsen@regionh.dk
Site Name
Odense University Hospital
Department Name
Department of Medical Gastroenterology
Principal Investigator Name
Jens Kjeldsen
Principal Investigator Email
jens.kjeldsen@rsyd.dk
Contact Person Name
Jens Kjeldsen
Contact Person Email
jens.kjeldsen@rsyd.dk
Site Name
Aarhus University Hospital
Department Name
Department of Hepatology and Gastroenterology
Principal Investigator Name
Anders Kirch Dige
Principal Investigator Email
andedige@rm.dk
Contact Person Name
Anders Kirch Dige
Contact Person Email
andedige@rm.dk

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Iqvia Rds Inc.
Responsibilities
code:6
Name
Icon Development Solutions LLC
Responsibilities
code:4
Name
Iqvia Biotech LLC
Responsibilities
code:6
Name
Clario
Responsibilities
code:4

Third parties

  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Tier 1 Impact Pbc Inc.","duties_or_roles":"Study Development/Conduct – Study Training","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Study Development/Conduct – Patient Reimbursement and Travel Services","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"SiteRx (Middleware)","duties_or_roles":"Study Development/Conduct – Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Professional Case Management Clinical Trials LLC","duties_or_roles":"Study Development/Conduct – Patient Monitoring","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"codes:1,12,15,2,5; 15 value: Negotiation and Execution of Clinical Trial agreements with the participating sites, make study payments based on invoices","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"Study Development/Conduct – Distribution of Recruitment and Retention items to clinical research sites globally. Including serving as Importer of Record on Lilly's behalf.","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iterative Health, Inc","duties_or_roles":"Study Development/Conduct – Patient Screening, Recruitment, and/or Retention","organisation_type":"Health care"}
  • {"country":"United States","full_name":"WCG (Investigator Space)","duties_or_roles":"Development/Conduct – Study Training","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"code:4","organisation_type":"Industry"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Study Development/Conduct – Standard Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Lionbridge AG","duties_or_roles":"Translations of PE materials","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code:6","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Study Development/Conduct – Patient Screening, Recruitment, and/or Retention","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Study Development/conduct -Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Mirikizumab
Active Substance
MIRIKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE | SUBCUTANEOUS USE
Route
Intravenous or Subcutaneous
Authorisation Status
Authorised
Maximum Dose
300 mg (max daily dose amount field)
Investigational Product Name
Tirzepatide
Active Substance
TIRZEPATIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Maximum Dose
15 mg (max daily dose amount field)
Investigational Product Name
to match Tirzepatide
Modality
Other
Combination Treatment
Yes

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