Clinical trial • Phase III • Gastroenterology

Mirikizumab for Crohn's disease | Obesity or Overweight

Phase III trial of Mirikizumab for Crohn's disease | Obesity or Overweight.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease | Obesity or Overweight
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 + placebo (placebo to match tirzepatide) versus mirikizumab concomitantly administered with tirzepatide (tirzepatide up to mtd of 15 mg as stated); specific mirikizumab dosing schedule not detailed in the provided record.-controlled Phase III trial in Greece, Italy, Poland and others.

Randomised
Yes
Comparator
Mirikizumab + placebo (placebo to match Tirzepatide) versus Mirikizumab concomitantly administered with Tirzepatide (Tirzepatide up to MTD of 15 mg as stated); specific Mirikizumab dosing schedule not detailed in the provided record.
Target Sample Size
128
Trial Duration For Participant
364

Eligibility

Recruits 128 Vulnerable populations not selected (isVulnerablePopulationSelected: false). Study enrols adults only; informed consent required from each adult participant. eConsent platforms and translated ICFs are provided; no parental consent or child assent processes described..

Vulnerable Population
Vulnerable populations not selected (isVulnerablePopulationSelected: false). Study enrols adults only; informed consent required from each adult participant. eConsent platforms and translated ICFs are provided; no parental consent or child assent processes described.

Inclusion criteria

  • {"criterion_text":"- Have had a diagnosis of Crohn’s disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment with tests confirming the diagnosis."}
  • {"criterion_text":"- Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline."}
  • {"criterion_text":"- SES-CD score of at least 6 or 4 (isolated ileal)"}
  • {"criterion_text":"- Participants with 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."}
  • {"criterion_text":"- Be obese with a body mass index (BMI) of 30 or higher or be overweight with a BMI between 27 and 30 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 CD medication (like oral such as corticosteroids or azathioprine) and also not respond well to advanced CD therapies (like biologics or JAK inhibitors)."}

Exclusion criteria

  • {"criterion_text":"- Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis."}
  • {"criterion_text":"- Have more than 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum."}
  • {"criterion_text":"- Have a stoma, ileoanal pouch, or ostomy."}
  • {"criterion_text":"- Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline."}
  • {"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 by Crohn’s Disease Activity Index (CDAI), endoscopic remission, and at least 10% weight reduction.","definition_or_measurement_approach":"Clinical remission measured by Crohn’s Disease Activity Index (CDAI); endoscopic remission assessed by endoscopy (SES‑CD scoring); weight change measured as percent change from baseline (endpoint requires ≥10% weight reduction)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
128
Recruitment Window Months
31
Consent Approach
Informed consent obtained from adult participants (no vulnerable/paediatric consent indicated). eConsent is used/available (IQVIA/ZoomHealth eConsent materials and eConsent submission letter present). Multiple language ICFs and subject information sheets are provided (examples observed: Greek, Italian, Polish, Bulgarian, English, French, Dutch, Czech, Spanish, Hungarian, German), and participant-facing guidance and privacy/security addenda are included.

Methods

  • Digital advertising: search ads and digital ad copy/visuals (documents named 'Search Ads', 'Digital Ad Copy', 'Digital Ad Visuals') targeting potential participants online (country-specific masters present e.g., _ITA, _PL, _HU).
  • Social media campaigns: social media video assets (documents 'Social Media Video 1/2') for patient-facing recruitment.
  • Printed materials and local site outreach: posters and brochures (K2 Recruitment material Poster / Brochure) for clinic/site-based recruitment.
  • Physician referral: doctor referral letters (K2_Recruitment material_Letter Doctor Referral_Master_EN, country-specific referral letters) to engage clinicians to refer eligible patients.
  • Exclusive database messaging and targeted patient messaging (documents 'Exclusive Database Messaging', 'Patient Messaging') to reach pre‑existing patient lists/databases.
  • Patient landing pages and patient-facing materials (patient landing page documents) to funnel interested participants to study screening.
  • eConsent and remote/teleconsent platforms (e.g., IQVIA eConsent materials, ZoomHealth screenshots and Terms of Service) to enable remote consent and participant-facing screenshots and guides.
  • Country-specific tailored recruitment packs: country/language-specific masters and localized materials (e.g., _ITA, _PL, _GR, _HU versions).

Geography

Total Number Of Sites
101
Total Number Of Participants
171

Greece

Earliest CTIS Part Ii Submission Date
29-07-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
223
Number Of Sites
5
Number Of Participants
13

Sites

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

Italy

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
250
Number Of Sites
10
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Gastroenterologia
Contact Person Name
Francesco Costa
Contact Person Email
fcosta@med.unipi.it
Site Name
Azienda Ospediera Ospedali Riuniti Villa Sofia Cervello
Department Name
U.O.S.D. Malattie Infiammatorie Croniche Intestinali (M.I.C.I)
Contact Person Name
Ambrogio Orlando
Contact Person Email
ambrogiorlando@gmail.com
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Gastroenterology and Gastrointestinal Endoscopy
Contact Person Name
Silvio Danese
Contact Person Email
ibd.trials@hsr.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Gastroenterology and Endoscopy Unit
Contact Person Name
Flavio Caprioli
Contact Person Email
flavio.caprioli@unimi.it
Site Name
Azienda Socio Sanitaria Territoriale Rhodense
Department Name
U.O.C. di Gastroenterologia ed Endoscopia Digestiva
Contact Person Name
Simone Saibeni
Contact Person Email
saibo@tiscali.it
Site Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Department Name
SSD Malattie Infiammatorie Croniche Intestinali
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
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
Contact Person Name
Mastronardi Mauro
Contact Person Email
mauro21mastronardi@gmail.com
Site Name
Policlinico universitario Agostino Gemelli IRCCS
Department Name
Dipartimento di Medicina Interna e Gastroenterologia
Contact Person Name
Franco Scaldaferri
Site Name
IRCCS Humanitas Research Hospital
Department Name
IBD center
Contact Person Name
Alessandro Armuzzi
Contact Person Email
clinicaltrialsibd@humanitas.it

Poland

Earliest CTIS Part Ii Submission Date
12-08-2025
Latest Decision Or Authorization Date
07-03-2026
Processing Time Days
207
Number Of Sites
12
Number Of Participants
23

Sites

Site Name
Medrise Sp. z o.o.
Contact Person Name
Wit Danilkiewicz
Contact Person Email
wit.danilkiewicz@medrise.pl
Site Name
Korczowski Bartosz, Gabinet Lekarski
Contact Person Name
Bartosz Korczowski
Contact Person Email
korczowski@op.pl
Site Name
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
Contact Person Name
Katarzyna Ostrowska
Contact Person Email
gastrolog1@ir-med.pl
Site Name
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
Contact Person Name
Piotr Eder
Contact Person Email
piotreder@ump.edu.pl
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Beata Gawdis-Wojnarska
Contact Person Email
gawdis@twojaprzychodnia.com
Site Name
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Ewa Furmanowska-Ladorska
Site Name
Gyncentrum Sp. z o.o.
Contact Person Name
Alina Kuryłowicz
Contact Person Email
a.kurylowicz@holsaclinical.com
Site Name
Medical Network Sp. z o.o.
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@med-net.pl
Site Name
Vivamed Sp. z o.o.
Contact Person Name
Robert Petryka
Contact Person Email
robert@petrykamed.com
Site Name
Etg Zamosc Sp. z o.o.
Contact Person Name
Katarzyna Wójcik
Contact Person Email
k.wojcik@etg-network.com
Site Name
Twoja Przychodnia Opolskie Centrum Medyczne
Contact Person Name
Agata Lukawska
Contact Person Email
alukawska@opolemed.com
Site Name
Melita Medical Sp. z o.o.
Contact Person Name
Janusz Leszczyszyn
Contact Person Email
j.leszczyszyn@melitamedical.pl

Hungary

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
263
Number Of Sites
4
Number Of Participants
7

Sites

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

Bulgaria

Earliest CTIS Part Ii Submission Date
20-08-2025
Latest Decision Or Authorization Date
06-04-2026
Processing Time Days
229
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Gastroenterology
Contact Person Name
Plamen Ivanov Penchev
Contact Person Email
penchev.dr@gmail.com
Site Name
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department Name
Gastroenterology
Contact Person Name
Nikolay Tsonev
Contact Person Email
dr.n.tsonev@abv.bg
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
First Internal Department
Contact Person Name
Ilko Kosturkov
Contact Person Email
ikosturkov@mcmedicaplus.com

Netherlands

Earliest CTIS Part Ii Submission Date
13-08-2025
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
201
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Gasteroenterology
Contact Person Name
Marjolijn Duijvestein
Site Name
Amsterdam UMC
Department Name
IBD trial Unit
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
Contact Person Name
Annemarie de Vries
Contact Person Email
a.c.devries@erasmusmc.nl
Site Name
Ikazia Ziekenhuis
Department Name
Gastroenterology - Hepatology
Contact Person Name
Geert Bezemer
Contact Person Email
g.bezemer@ikazia.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Gastroenterology
Contact Person Name
Herma Fidder
Contact Person Email
h.h.fidder@umcutrecht.nl

Belgium

Earliest CTIS Part Ii Submission Date
30-07-2025
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
233
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
Gastroenterology Department
Contact Person Name
Edouard Louis
Contact Person Email
edouard.louis@uliege.be
Site Name
CHC MontLegia
Department Name
Gastroenterology
Contact Person Name
Arnaud Colard
Contact Person Email
arnaud.colard@chc.be
Site Name
Hopital Erasme
Department Name
Clinical Research - Gastroenterology Department
Contact Person Name
Denis Franchimont
Site Name
CHC Azorg
Department Name
Gastroenterology
Contact Person Name
Stijn Vanden Branden
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
gastroenterology
Contact Person Name
Wouter Van Moerkercke
Site Name
UZ Leuven
Department Name
Gastroenterology - Inflammatory Bowel Disease
Contact Person Name
João Guedelha Sabino
Contact Person Email
joao.sabino@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege (second site listed)
Department Name
Gastroenterology

France

Earliest CTIS Part Ii Submission Date
01-08-2025
Latest Decision Or Authorization Date
03-03-2026
Processing Time Days
214
Number Of Sites
11
Number Of Participants
19

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
HGEA
Contact Person Name
Anne Bozon
Contact Person Email
aan-bozon@chu-montpellier.fr
Site Name
Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name
Institut des MICI
Contact Person Name
Xavier Treton
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Gastroentérologie
Contact Person Name
Nicolas Richard
Contact Person Email
nicolas.richard@chu-rouen.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Gastroenterology
Contact Person Name
Astrid De Maissin
Contact Person Email
astrid.demaissin@ght85.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
GASTROENTEROLOGY
Contact Person Name
Cyrielle Gilletta
Contact Person Email
gilletta.c@chu-toulouse.fr
Site Name
Clinique Des Cedres.
Department Name
MICI Institut Privé
Contact Person Name
Nicolas Mathieu
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Service Gastro entérologie
Contact Person Name
Mathilde Barrau
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Unité de recherche clinique gastroentérologie et nutrition clinique
Contact Person Name
Stephane Schneider
Contact Person Email
schneider.s@chu-nice.fr
Site Name
Hopital Saint Antoine
Department Name
Gastroenterologie et nutrition
Contact Person Name
Julien Kirchgesner
Contact Person Email
julien.kirchgesner@aphp.fr
Site Name
Clinique Pasteur
Department Name
Gastro-hepato-entérologie
Contact Person Name
Patrick Faure
Contact Person Email
pfaure@clinique-pasteur.com
Site Name
Bicetre Hospital
Department Name
Hépato-gastroentérologie
Contact Person Name
Aurelien Amiot
Contact Person Email
aurelien.amiot@aphp.fr

Spain

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
240
Number Of Sites
11
Number Of Participants
15

Sites

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

Austria

Earliest CTIS Part Ii Submission Date
30-07-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
222
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Contact Person Name
Walter Reinisch
Site Name
Medical University Of Graz
Department Name
Department of Internal Medicine, Division of Gastroenterology and Hepatology
Contact Person Name
Christoph Hoegenauer
Site Name
Medizinische Universitaet Innsbruck
Department Name
Internal Medicine 1
Contact Person Name
Robert Koch
Contact Person Email
robert.koch@i-med.ac.at

Romania

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
266
Number Of Sites
7
Number Of Participants
6

Sites

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

Slovakia

Earliest CTIS Part Ii Submission Date
31-07-2025
Latest Decision Or Authorization Date
03-03-2026
Processing Time Days
215
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Cliniq s.r.o.
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
Gastroenterology
Contact Person Name
Jozef Balaz
Contact Person Email
balaz78@gmail.com
Site Name
Gastro LM s.r.o.
Contact Person Name
Lubomir Mihalkanin
Contact Person Email
mihalkanin@gmail.com
Site Name
Endomed s.r.o.
Contact Person Name
Miroslav Fedurco
Contact Person Email
fedurco@endomed.sk

Germany

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
242
Number Of Sites
6
Number Of Participants
13

Sites

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

Czechia

Earliest CTIS Part Ii Submission Date
23-07-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
258
Number Of Sites
7
Number Of Participants
18

Sites

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

Denmark

Earliest CTIS Part Ii Submission Date
19-08-2025
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
262
Number Of Sites
6
Number Of Participants
11

Sites

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

Sponsor

Primary sponsor

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

Contract research organisations

Name
WCG Clinical Inc.
Responsibilities
Study Development/Conduct_Study Training
Name
Icon Development Solutions LLC
Responsibilities
Study development/conduct responsibilities (operational/CRO support)
Name
Iqvia Rds Inc.
Responsibilities
Clinical operations support / data services
Name
Bioclinica Inc.
Responsibilities
Operational support / data services

Third parties

  • {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"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":"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":"WCG Clinical Inc.","duties_or_roles":"Study Development/Conduct_Study Training","organisation_type":"Industry"}
  • {"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":"Cleveland Clinic Foundation","duties_or_roles":"Study Development/conduct_Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"Sponsor duty code: 4 (role detail not provided in summary)","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":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Study Development/Conduct_Standard Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc. (duplicate entry)","duties_or_roles":"Data Management_Linguistically Validated Translations","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":"Iqvia Rds Inc.","duties_or_roles":"Sponsor duty code: 6 (role detail not provided in summary) / Study Development/Conduct support in other entries","organisation_type":"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":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"Negotiation and Execution of Clinical Trial Agreements with the participating sites, make study payments based on invoices; other sponsor responsibilities (codes 1,12,15,2,5 listed).","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Study Development/Conduct_Adjudication (code 4)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Lionbridge AG","duties_or_roles":"Translation of PE materials","organisation_type":"Health care (translation vendor)"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Study Development/Conduct_ (code 4 - training or operational support)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Study Development/Conduct_ (code 4)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services Sàrl","duties_or_roles":"Study Development/Conduct_ (code 4)","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Data management / CDMS support (code 6)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States/Canada/Switzerland/Greece","full_name":"Professional vendor and laboratories (additional listed third parties)","duties_or_roles":"Multiple roles including translations, patient reimbursement/travel services, study training, adjudication, patient monitoring, data management and translations as listed in sponsor third-party duties.","organisation_type":"Various (industry, health care, laboratory, translation)"}

Investigational products

Investigational Product Name
Mirikizumab
Active Substance
Mirikizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous administration | Subcutaneous use
Route
Intravenous / Subcutaneous
Authorisation Status
Authorised (prodAuthStatus: 1 indicated in product dictionary)
Maximum Dose
900 mg (maxDailyDoseAmount listed as 900 mg in product record)
Investigational Product Name
Tirzepatide
Active Substance
Tirzepatide
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
Authorised (prodAuthStatus: 1 indicated in product dictionary)
Maximum Dose
15 mg (maxDailyDoseAmount listed as 15 mg, trial objective references MTD up to 15 mg)
Investigational Product Name
to match Tirzepatide (placebo)
Modality
Other
Combination Treatment
Yes

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