Clinical trial • Phase III • Cardiology

CORAMITUG for Transthyretin amyloid cardiomyopathy (ATTR-CM)

Phase III trial of CORAMITUG for Transthyretin amyloid cardiomyopathy (ATTR-CM).

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Transthyretin amyloid cardiomyopathy (ATTR-CM)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
18-08-2025
First CTIS Authorization Date
09-12-2025

Trial design

Randomised, placebo group: 'liquid dosage form in 20 ml vials with 11 extractable volume' administered as placebo, added to standard of care (soc). (no dose or schedule for placebo specified in the provided data).-controlled Phase III trial in Belgium, Czechia, Denmark and others.

Randomised
Yes
Comparator
Placebo group: 'liquid dosage form in 20 mL vials with 11 extractable volume' administered as placebo, added to Standard of Care (SoC). (No dose or schedule for placebo specified in the provided data).
Target Sample Size
735

Eligibility

Recruits 735 Vulnerable population flag selected in trial metadata. Participants must be aged 18 years or above and provide informed consent. Subject information and informed consent forms (L1_... SIS-ICF documents) are provided (multiple country/language versions). Additional partner/pregnant partner and pre-screening consent materials are listed (e.g., Male Partner, Pregnant partner forms). No separate assent process for minors is applicable because minimum age is 18 years..

Vulnerable Population
Vulnerable population flag selected in trial metadata. Participants must be aged 18 years or above and provide informed consent. Subject information and informed consent forms (L1_... SIS-ICF documents) are provided (multiple country/language versions). Additional partner/pregnant partner and pre-screening consent materials are listed (e.g., Male Partner, Pregnant partner forms). No separate assent process for minors is applicable because minimum age is 18 years.

Inclusion criteria

  • {"criterion_text":"- 1.\tMale or female.\n- 2.\tAge 18 years or above at the time of signing the informed consent.\n- 3.\tHave an established diagnosis of ATTR-CM, (ATTRwt or ATTRv), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF. Note: Target ATTRv recruitment is approximately 15% of the study population. a.\tCardiac amyloid infiltration demonstrated by: i.\tCardiac biopsy positive for TTR amyloid, OR, ii.\tGrade 2 or 3 cardiac uptake at PYP/DPD/HMDP scintigraphy with single-photon emission computed tomography (SPECT/CT) combined with an extracardiac biopsy positive for TTR amyloid, OR, iii.\tGrade 2 or 3 cardiac uptake at PYP/DPD/HMDP scintigraphy with SPECT/CT combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE & UPIE). Notes: o\tNon-invasive diagnostic pathway will be confirmed by a centralised expert review. o\tBone tracer scintigraphy will be conducted using 99m-technetium (Tc)-labelled pyrophosphate (99mTc-PYP)/99mTc-labelled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc DPD)/99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP).\n b.\tIncreased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness ≥12 mm.\n c.\tChronic HF (New York Heart Classification [NYHA] I-IV) requiring ongoing treatment with a loop diuretic with: i.\tAt least 1 documented hospitalisation for HF, OR ii.\tHistory of HF manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath, signs of pulmonary congestion on x-ray or auscultation, or peripheral oedema).\n- 4.\tExpected to be on stable CV medical therapy (defined as no greater than 50% dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit.\n- 5.\tNT-proBNP concentration ≥\"CCI\" pg/mL at screening. Note: Participants with NT-proBNP levels between \"CCI\" and \"CCI\" pg/mL may be enrolled until a cap of 35% of the total study population is reached.\n- 6.\tCompleted >50 meters on the 6MWT at screening."}

Exclusion criteria

  • {"criterion_text":"- 1.\tKnown or suspected hypersensitivity to study intervention(s) or related products.\n- 10.\tPrior solid organ transplant or planned solid organ transplant during the study.\n- 11.\tLeft ventricular ejection fraction (LVEF) <30% as assessed by centralised review of echocardiography.\n- 12.\tPresence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or carcinoma in situ/high-grade prostatic intraepithelial neoplasia (PIN), low-risk prostate cancer or on stable therapy for prostate cancer) within 3 years before screening.\n- 13.\tEnd stage renal disease (estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2 at screening, or chronic/intermittent haemodialysis or peritoneal dialysis).\n- 2.\tCurrent or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.\n- 3.\tTotal bilirubin >3 × upper limit of normal (ULN) at screening.\n- 4.\tCurrent diagnosis or history of amyloid light chain, other non-ATTR amyloidosis or known leptomeningeal amyloidosis, or multiple myeloma.\n- 5.\tHF not primarily caused by ATTR-CM, for example, due to hypertension, valvular heart disease, or ischemic heart disease in the opinion of the investigator.\n- 6.\tCurrently hospitalised or hospitalised within 14 days prior to screening.\n- 7.\tCurrently treated with positive inotropic medication.\n- 8.\tUncorrected, severe, haemodynamically significant, left-sided heart valve disease. Note: pre existing echocardiogram up to 2 years old may be used.\n- 9.\tAcute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 60 days of screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of occurrences of the composite endpoint consisting of: •\tCV death •\tRecurrent CV events (CV hospitalisation and urgent HF visits )","definition_or_measurement_approach":"Composite endpoint counting occurrences of cardiovascular (CV) death and recurrent CV events (defined as CV hospitalisation and urgent heart failure visits). Events are counted as occurrences of the composite; components are CV death and recurrent CV events (CV hospitalisation and urgent HF visits)."}

Secondary endpoints

  • {"endpoint_text":"- Secondary Confirmatory: Change in KCCQ-CSS","definition_or_measurement_approach":"Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline."}
  • {"endpoint_text":"- Change in 6MWD","definition_or_measurement_approach":"Change in six-minute walk distance (6MWD) from baseline."}
  • {"endpoint_text":"- Number of occurrences of CV events (CV hospitalisation and urgent HF visits)","definition_or_measurement_approach":"Count of cardiovascular events defined as CV hospitalisations and urgent heart failure visits."}
  • {"endpoint_text":"- Time to occurrence of CV death","definition_or_measurement_approach":"Time-to-event analysis measuring time from randomisation to CV death."}
  • {"endpoint_text":"- Time to occurrence of all-cause death","definition_or_measurement_approach":"Time-to-event analysis measuring time from randomisation to death from any cause."}
  • {"endpoint_text":"- Time to first occurrence of composite CKD endpoint: •\tCV death •\tOnset of persistent decline eGFR ≥ 30% •\tOnset of persistent eGFR < 15 mL/min/1.73m2 •\tInitiation of chronic kidney replacement therapy (dialysis or kidney transplant)","definition_or_measurement_approach":"Composite chronic kidney disease (CKD) endpoint measured as time to first of the listed events: CV death; onset of persistent decline in eGFR ≥30%; onset of persistent eGFR <15 mL/min/1.73m2; initiation of chronic kidney replacement therapy (dialysis or kidney transplant)."}
  • {"endpoint_text":"- Change in KCCQ-OSS","definition_or_measurement_approach":"Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) from baseline."}

Recruitment

Registry Or Advocacy Recruitment
True, Fondazione Toscana Gabriele Monasterio
Digital Remote Recruitment
True - digital methods explicitly include Facebook advertising (Facebook Ad documents), digital outreach / participant recruitment digital outreach, and informational website materials; these are present country-specifically in multiple countries' K2 recruitment materials.
Planned Sample Size
735
Recruitment Window Months
30
Consent Approach
Informed consent obtained from each participant (minimum age 18). Subject information and informed consent forms (L1 SIS-ICF documents) are provided in multiple country-specific language versions (examples: French, Dutch, English for BE; Czech; Danish; French; German; Italian; Spanish; Dutch). Additional consent-related materials include pre-screening forms, 'Future Research' information, male partner and pregnant partner forms, and optional imaging consent documents where applicable.

Methods

  • Country recruitment procedures (K1 documents) present for participating countries (e.g., K1_BE_Recruitment Procedure, K1_CZ_Recruitment Procedure_Bilingual, K1_DK_Recruitment Procedure, K1_FR_Recruitment Procedure_Bilingual, K1_IT_Recruitment Procedure, K1_ES_Recruitment procedure, K1_NL_Recruitment Procedure).
  • Digital outreach including Facebook Ads and 'Participant Recruitment Digital Outreach' (documents titled 'Facebook Ad', 'Participant Recruitment Digital Outreach', 'Digital Outreach' present for multiple countries).
  • Printed materials and local media: Posters and Brochures (K2_* Recruitment Material_Poster, _Brochure) targeted to patients in local languages.
  • Patient-facing communications: Patient Letters and Appointment Reminder Cards (K2_* Patient Letter, Appointment Reminder Card) distributed to potential/consented participants.
  • Advocacy engagement: Advocacy Fact Sheets (K2_* Advocacy Fact Sheet) for outreach to patient organisations and advocacy groups.
  • Informational website/digital information pages (documents titled 'Informational Website' and 'Information Website').
  • Study Visit Guides and other subject materials (Study Visit Guide, Subject Participation Card) provided to participants.

Geography

Total Number Of Sites
97
Total Number Of Participants
545

Belgium

Earliest CTIS Part Ii Submission Date
20-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
19
Number Of Sites
11
Number Of Participants
97

Sites

Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Cardiology
Principal Investigator Name
Philippe Debonnaire
Principal Investigator Email
cardiologie@azsintjan.be
Contact Person Name
Philippe Debonnaire
Contact Person Email
cardiologie@azsintjan.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Cardiology
Principal Investigator Name
Laurence Gabriel
Principal Investigator Email
laurence.gabriel@chuuclnamur.uclouvain.be
Contact Person Name
Laurence Gabriel
Site Name
Azorg
Department Name
Cardiology
Principal Investigator Name
Marc Vanderheyden
Principal Investigator Email
marc.vanderheyden@azorg.be
Contact Person Name
Marc Vanderheyden
Contact Person Email
marc.vanderheyden@azorg.be
Site Name
Ziekenhuis Aan De Stroom
Department Name
Cardiology
Principal Investigator Name
Edgard Prihadi
Principal Investigator Email
edgard.prihadi@zas.be
Contact Person Name
Edgard Prihadi
Contact Person Email
edgard.prihadi@zas.be
Site Name
AZ Sint-Blasius Campus Dendermonde
Department Name
Cardiology/intensive Care at AZ Sint-Blasius (same address)
Principal Investigator Name
Tom Sarens
Principal Investigator Email
tomsarens@hotmail.com
Contact Person Name
Tom Sarens
Contact Person Email
tomsarens@hotmail.com
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Cardiology
Principal Investigator Name
Béatrice Miltner
Principal Investigator Email
beatrice.miltner@citadelle.be
Contact Person Name
Béatrice Miltner
Contact Person Email
beatrice.miltner@citadelle.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Cardiology
Principal Investigator Name
Bernhard Gerber
Principal Investigator Email
bernhard.gerber@saintluc.uclouvain.be
Contact Person Name
Bernhard Gerber
Site Name
UZ Leuven
Department Name
Cardiology
Principal Investigator Name
Lucas Van Aelst
Principal Investigator Email
lucas.vanaelst@uzleuven.be
Contact Person Name
Lucas Van Aelst
Contact Person Email
lucas.vanaelst@uzleuven.be
Site Name
UZ Brussel
Department Name
Cardiology
Principal Investigator Name
Steven Droogmans
Principal Investigator Email
steven.droogmans@uzbrussel.be
Contact Person Name
Steven Droogmans
Contact Person Email
steven.droogmans@uzbrussel.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Cardiology
Principal Investigator Name
Matthias Dupont
Principal Investigator Email
matthias.dupont@zol.be
Contact Person Name
Matthias Dupont
Contact Person Email
matthias.dupont@zol.be
Site Name
Hopital Erasme
Department Name
Cardiology
Principal Investigator Name
Antoine Bondue
Principal Investigator Email
antoine.bondue@hubruxelles.be
Contact Person Name
Antoine Bondue
Contact Person Email
antoine.bondue@hubruxelles.be

Czechia

Earliest CTIS Part Ii Submission Date
20-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
19
Number Of Sites
7
Number Of Participants
43

Sites

Site Name
University Hospital Olomouc
Department Name
I. interní klinika - kardiologická
Principal Investigator Name
Renáta Aiglová
Principal Investigator Email
renata.aiglova@fnol.cz
Contact Person Name
Renáta Aiglová
Contact Person Email
renata.aiglova@fnol.cz
Site Name
Clinical Trials Service s.r.o.
Department Name
-
Principal Investigator Name
Vladimír Čech
Principal Investigator Email
vlad.cech@gmail.com
Contact Person Name
Vladimír Čech
Contact Person Email
vlad.cech@gmail.com
Site Name
Fakultni Nemocnice Ostrava
Department Name
Interní a kardiologická klinika
Principal Investigator Name
Jan Václavík
Principal Investigator Email
jan.vaclavik@fno.cz
Contact Person Name
Jan Václavík
Contact Person Email
jan.vaclavik@fno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
II. interní klinika – klinika kardiologie a angiologie
Principal Investigator Name
Tomáš Paleček
Principal Investigator Email
Tomas.palecek@vfn.cz
Contact Person Name
Tomáš Paleček
Contact Person Email
Tomas.palecek@vfn.cz
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Klinika kardiologie
Principal Investigator Name
Miloš Kubánek
Principal Investigator Email
milos.kubanek@ikem.cz
Contact Person Name
Miloš Kubánek
Contact Person Email
milos.kubanek@ikem.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
I. interní kardioangiologická klinika
Principal Investigator Name
Jan Krejčí
Principal Investigator Email
Jan.krejci@fnusa.cz
Contact Person Name
Jan Krejčí
Contact Person Email
Jan.krejci@fnusa.cz
Site Name
Edumed s.r.o.
Department Name
Kardiologická ambulance
Principal Investigator Name
Jiří Veselý
Principal Investigator Email
vesely.edumed@gmail.com
Contact Person Name
Jiří Veselý
Contact Person Email
vesely.edumed@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
21-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
18
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
Region Midtjylland
Department Name
Department of Cardiology
Principal Investigator Name
Steen Poulsen
Principal Investigator Email
steepoul@rm.dk
Contact Person Name
Steen Poulsen
Contact Person Email
steepoul@rm.dk
Site Name
Rigshospitalet
Department Name
The Heart Center
Principal Investigator Name
Kasper Rossing
Principal Investigator Email
Kasper.rossing@regionh.dk
Contact Person Name
Kasper Rossing
Contact Person Email
Kasper.rossing@regionh.dk
Site Name
Odense University Hospital
Department Name
Department of Cardiology
Principal Investigator Name
Michael Maiborg
Principal Investigator Email
Michael.maiborg@rsyd.dk
Contact Person Name
Michael Maiborg
Contact Person Email
Michael.maiborg@rsyd.dk

France

Earliest CTIS Part Ii Submission Date
24-11-2025
Latest Decision Or Authorization Date
11-12-2025
Processing Time Days
17
Number Of Sites
19
Number Of Participants
81

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
UMCV
Principal Investigator Name
Patricia Reant
Principal Investigator Email
patricia.reant@chu-bordeaux.fr
Contact Person Name
Patricia Reant
Contact Person Email
patricia.reant@chu-bordeaux.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Cardiology
Principal Investigator Name
Thibaud Damy
Principal Investigator Email
Thibaud.damy@aphp.fr
Contact Person Name
Thibaud Damy
Contact Person Email
Thibaud.damy@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Cardiology
Principal Investigator Name
Delphine Baudouy
Principal Investigator Email
baudouy.d@chu-nice.fr
Contact Person Name
Delphine Baudouy
Contact Person Email
baudouy.d@chu-nice.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Cardiology
Principal Investigator Name
Olivier Lairez
Principal Investigator Email
Lairez.o@chu-toulouse.fr
Contact Person Name
Olivier Lairez
Contact Person Email
Lairez.o@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris (20 Rue Leblanc)
Department Name
Cardiology
Principal Investigator Name
Albert Hagege
Principal Investigator Email
albert.hagege@aphp.fr
Contact Person Name
Albert Hagege
Contact Person Email
albert.hagege@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (46 Rue Henri Huchard)
Department Name
Cardiology
Principal Investigator Name
Vincent Algalarrondo
Principal Investigator Email
vincent.algalarrondo@aphp.fr
Contact Person Name
Vincent Algalarrondo
Contact Person Email
vincent.algalarrondo@aphp.fr
Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Department Name
Cardiology
Principal Investigator Name
Jean-Michel Tartiere
Principal Investigator Email
jean-michel.tartiere@ch-toulon.fr
Contact Person Name
Jean-Michel Tartiere
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Cardiology
Principal Investigator Name
Emmanuelle Vermes
Principal Investigator Email
vermes.emmanuelle@chu-amiens.fr
Contact Person Name
Emmanuelle Vermes
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Cardiology
Principal Investigator Name
François Roubille
Principal Investigator Email
f-roubille@chu-montpellier.fr
Contact Person Name
François Roubille
Contact Person Email
f-roubille@chu-montpellier.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Cardiology
Principal Investigator Name
Fabien Miette
Principal Investigator Email
fabien.miette@ght58.fr
Contact Person Name
Fabien Miette
Contact Person Email
fabien.miette@ght58.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Cardiology
Principal Investigator Name
Jean-Christophe Eicher
Principal Investigator Email
jean-christophe.eicher@chu-dijon.fr
Contact Person Name
Jean-Christophe Eicher
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Cardiology
Principal Investigator Name
Mathieu Chacornac
Principal Investigator Email
mchacornac@ch-annecygenevois.fr
Contact Person Name
Mathieu Chacornac
Site Name
Medipole Hopital Prive
Department Name
Cardiology
Principal Investigator Name
Antoine Jobbe-Duval
Principal Investigator Email
a.jobbeduval@resamut.fr
Contact Person Name
Antoine Jobbe-Duval
Contact Person Email
a.jobbeduval@resamut.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Cardiology
Principal Investigator Name
Benjamin Alos
Principal Investigator Email
benjamin.alos@chu-poitiers.fr
Contact Person Name
Benjamin Alos
Contact Person Email
benjamin.alos@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Cardiology
Principal Investigator Name
Nicolas Prirou
Principal Investigator Email
nicolas.piriou@chu-nantes.fr
Contact Person Name
Nicolas Prirou
Contact Person Email
nicolas.piriou@chu-nantes.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Cardiology
Principal Investigator Name
Anne Bernard
Principal Investigator Email
anne.bernard@univ-tours.fr
Contact Person Name
Anne Bernard
Contact Person Email
anne.bernard@univ-tours.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Cardiology
Principal Investigator Name
Gilbert Habib
Principal Investigator Email
gilbert.habib@ap-hm.fr
Contact Person Name
Gilbert Habib
Contact Person Email
gilbert.habib@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Cardiology and Vascular Diseases Department
Principal Investigator Name
Erwan Donal
Principal Investigator Email
erwan.donal@chu-rennes.fr
Contact Person Name
Erwan Donal
Contact Person Email
erwan.donal@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Cardiology
Principal Investigator Name
Gilles Barone-Rochette
Principal Investigator Email
gbarone@chu-grenoble.fr
Contact Person Name
Gilles Barone-Rochette
Contact Person Email
gbarone@chu-grenoble.fr

Germany

Earliest CTIS Part Ii Submission Date
27-11-2025
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
15
Number Of Sites
11
Number Of Participants
68

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Kardiologie und internistische Intensivmedizin
Principal Investigator Name
Johanne Frank
Principal Investigator Email
Johanne.Frank@uksh.de
Contact Person Name
Johanne Frank
Contact Person Email
Johanne.Frank@uksh.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Stephanie Schwarting
Principal Investigator Email
Stephanie.Bieber@med.uni-muenchen.de
Contact Person Name
Stephanie Schwarting
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Deutsches Zentrum für Herzinsuffizienz Würzburg
Principal Investigator Name
Caroline Morbach
Principal Investigator Email
Morbach_C@ukw.de
Contact Person Name
Caroline Morbach
Contact Person Email
Morbach_C@ukw.de
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Herzzentrum Med. Klinik III
Principal Investigator Name
Roman Pfister
Principal Investigator Email
Roman.pfister@uk-koeln.de
Contact Person Name
Roman Pfister
Contact Person Email
Roman.pfister@uk-koeln.de
Site Name
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Department Name
Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
Principal Investigator Name
Smita Scholtz
Principal Investigator Email
Sscholtz@hdz-nrw.de
Contact Person Name
Smita Scholtz
Contact Person Email
Sscholtz@hdz-nrw.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
DHZC Klinik für Kardiologie, Angiologie und Intensivmedizin
Principal Investigator Name
Kathrin Hahn
Principal Investigator Email
Katrin.hahn@charite.de
Contact Person Name
Kathrin Hahn
Contact Person Email
Katrin.hahn@charite.de
Site Name
Medical Center - University Of Freiburg
Department Name
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Principal Investigator Name
Sebastian Grundmann
Principal Investigator Email
sebastian.grundmann@uniklinik-freiburg.de
Contact Person Name
Sebastian Grundmann
Site Name
Universitaet Muenster
Department Name
Herz-MRT-Zentrum
Principal Investigator Name
Ali Yilmaz
Principal Investigator Email
ali.yilmaz@ukmuenster.de
Contact Person Name
Ali Yilmaz
Contact Person Email
ali.yilmaz@ukmuenster.de
Site Name
TUM Klinikum Deutsches Herzzentrum
Department Name
Klinik für Herz- und Kreislauferkrankungen und für angeborene Herzfehler und Kinderkardiologie
Principal Investigator Name
Teresa Trenkwalder
Principal Investigator Email
trenkwalder@dhm.mhn.de
Contact Person Name
Teresa Trenkwalder
Contact Person Email
trenkwalder@dhm.mhn.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin I (Kardiologie, Angiologie, Internistische Intensivmedizin)
Principal Investigator Name
Julian Westphal
Principal Investigator Email
KIM1-Chefsekretariat@med.uni-jena.de
Contact Person Name
Julian Westphal
Site Name
Herzzentrum Dresden GmbH Universitaetsklinik
Department Name
Klinik für Innere Medizin und Kardiologie
Principal Investigator Name
Ephraim Winzer
Principal Investigator Email
Ephraim.Winzer@tu-dresden.de
Contact Person Name
Ephraim Winzer
Contact Person Email
Ephraim.Winzer@tu-dresden.de

Italy

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
46
Number Of Sites
23
Number Of Participants
95

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Unità di Cardiologia
Principal Investigator Name
Daniela Tomasoni
Principal Investigator Email
danielatomasoni8@gmail.com
Contact Person Name
Daniela Tomasoni
Contact Person Email
danielatomasoni8@gmail.com
Site Name
Policlinico San Donato S.p.A.
Department Name
Dipartimento Cardiologia
Principal Investigator Name
Massimo Francesco Piepoli
Principal Investigator Email
massimo.piepoli@unimi.it
Contact Person Name
Massimo Francesco Piepoli
Contact Person Email
massimo.piepoli@unimi.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Cardiology Unit, Cardio-Thoracic and Vascular Department
Principal Investigator Name
Simone Longhi
Principal Investigator Email
simone.longhi@aosp.bo.it
Contact Person Name
Simone Longhi
Contact Person Email
simone.longhi@aosp.bo.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Unità Operativa Complessa UTIC
Principal Investigator Name
Gianluca Di Bella
Principal Investigator Email
gianluca.dibella@tiscali.it
Contact Person Name
Gianluca Di Bella
Contact Person Email
gianluca.dibella@tiscali.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Dipartimento Scienze Cardiovascolari, Diagnostica per Immagini e Rete Emergenze Tempo-Dip.
Principal Investigator Name
Maria Angela Losi
Principal Investigator Email
mariaangela.losi@unina.it
Contact Person Name
Maria Angela Losi
Contact Person Email
mariaangela.losi@unina.it
Site Name
Azienda Ospedaliera Dei Colli
Department Name
Dipartimento scienze mediche traslazionali
Principal Investigator Name
Giuseppe Limongelli
Principal Investigator Email
giuseppe.limongelli@ospedalideicolli.it
Contact Person Name
Giuseppe Limongelli
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Cardiology
Principal Investigator Name
Giuseppina Novo
Principal Investigator Email
giuseppina.novo@unipa.it
Contact Person Name
Giuseppina Novo
Contact Person Email
giuseppina.novo@unipa.it
Site Name
Azienda Sanitaria Locale TO4
Department Name
Cardiology
Principal Investigator Name
Walter Grosso Marra
Principal Investigator Email
wgrossomarra@aslto4.piemonte.it
Contact Person Name
Walter Grosso Marra
Site Name
University Hospital Of Ferrara
Department Name
AOU Ferrara - Arcispedale Sant' Anna - Cardiology Unit
Principal Investigator Name
Matteo Serenelli
Principal Investigator Email
m.serenelli@ospfe.it
Contact Person Name
Matteo Serenelli
Contact Person Email
m.serenelli@ospfe.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
S.C. Cardiologia 4 - Centro di Ecocardiografia Clinica
Principal Investigator Name
Francesco Musca
Principal Investigator Email
francesco.musca@ospedaleniguarda.it
Contact Person Name
Francesco Musca
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Cardiology Unit
Principal Investigator Name
Maria Beatrice Musumeci
Principal Investigator Email
beatrice.musumeci@uniuniromal.it
Contact Person Name
Maria Beatrice Musumeci
Site Name
Alessandro Manzoni Hospital
Department Name
Cardiology
Principal Investigator Name
Roberto Spoladore
Principal Investigator Email
r.spoladore@asstlecco.it
Contact Person Name
Roberto Spoladore
Contact Person Email
r.spoladore@asstlecco.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Department of Cardio-Thoracic Vascular Diseases
Principal Investigator Name
Stefano Carugo
Principal Investigator Email
Stefano.carugo@policlinico.mi.it
Contact Person Name
Stefano Carugo
Site Name
Ospedale Isola Tiberina Gemelli Isola
Department Name
Diagnostic and Interventional Cardiology
Principal Investigator Name
Antonio Maria Leone
Principal Investigator Email
antoniomaria.leone@fbf-isola.it
Contact Person Name
Antonio Maria Leone
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
UOC Cardiologia
Principal Investigator Name
Ines Paola Monte
Principal Investigator Email
Ines.monte@unict.it
Contact Person Name
Ines Paola Monte
Contact Person Email
Ines.monte@unict.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Cardiology Unit
Principal Investigator Name
Eustachio Agricola
Principal Investigator Email
agricola.eustachio@hsr.it
Contact Person Name
Eustachio Agricola
Contact Person Email
agricola.eustachio@hsr.it
Site Name
Azienda Ospedaliera Di Perugia
Department Name
Cardiology and Cardiovascular Pathophysiology Unit
Principal Investigator Name
Erberto Carluccio
Principal Investigator Email
erberto.carluccio@ospedale.perugia.it
Contact Person Name
Erberto Carluccio
Site Name
Centro Cardiologico Monzino S.p.A.
Department Name
Dipartimento di Cardiologia Critica e Riabilitativa
Principal Investigator Name
Piergiuseppe Agostoni
Principal Investigator Email
piergiuseppe.agostoni@ccfm.it
Contact Person Name
Piergiuseppe Agostoni
Contact Person Email
piergiuseppe.agostoni@ccfm.it
Site Name
Fondazione Toscana Gabriele Monasterio
Department Name
Dipartimento Cardiotoracico UC Cardiologia e Medicina Cardiovascolare
Principal Investigator Name
Michele Emdin
Principal Investigator Email
michele.emdin@ftgm.it
Contact Person Name
Michele Emdin
Contact Person Email
michele.emdin@ftgm.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
Polo Cardiologico, via Pietro Valdoni 7
Principal Investigator Name
Marco Merlo
Contact Person Name
Marco Merlo
Site Name
Azienda Sanitaria Dell'Alto Adige
Department Name
Reparto Cardiologia e Prove Funzionali
Principal Investigator Name
Roberto Cemin
Principal Investigator Email
roberto.cemin@asbz.it
Contact Person Name
Roberto Cemin
Contact Person Email
roberto.cemin@asbz.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità
Principal Investigator Name
Giovanni Palladini
Principal Investigator Email
giovanni.palladini@unipv.it
Contact Person Name
Giovanni Palladini
Contact Person Email
giovanni.palladini@unipv.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Interventional Cardiological Structural SOD
Principal Investigator Name
Francesco Cappelli
Principal Investigator Email
f.cappelli@unifi.it
Contact Person Name
Francesco Cappelli
Contact Person Email
f.cappelli@unifi.it

Spain

Earliest CTIS Part Ii Submission Date
20-11-2025
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
20
Number Of Sites
21
Number Of Participants
122

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Cardiology
Principal Investigator Name
Maria Luisa Peña Peña
Principal Investigator Email
mluisa.pena.sspa@juntadeandalucia.es
Contact Person Name
Maria Luisa Peña Peña
Site Name
Hospital Son Llatzer
Department Name
Cardiology
Principal Investigator Name
Tomas Vicente Ripoll Vera
Principal Investigator Email
tripoll@hsll.es
Contact Person Name
Tomas Vicente Ripoll Vera
Contact Person Email
tripoll@hsll.es
Site Name
Hospital San Juan de la Cruz
Department Name
Internal Medicine
Principal Investigator Name
Juan Luis Bonilla Palomas
Principal Investigator Email
juanl.bonilla.sspa@juntadeandalucia.es
Contact Person Name
Juan Luis Bonilla Palomas
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Cardiology
Principal Investigator Name
Jose Ramon Gonzalez Juanatey
Principal Investigator Email
alfonso.varela.roman@sergas.es
Contact Person Name
Jose Ramon Gonzalez Juanatey
Contact Person Email
alfonso.varela.roman@sergas.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Cardiology
Principal Investigator Name
Jose Manuel Garcia Pinilla
Principal Investigator Email
pinilla@uma.es
Contact Person Name
Jose Manuel Garcia Pinilla
Contact Person Email
pinilla@uma.es
Site Name
Hospital Universitario Reina Sofia
Department Name
Cardiology
Principal Investigator Name
Juan Carlos Castillo Dominguez
Contact Person Name
Juan Carlos Castillo Dominguez
Site Name
Hospital Universitario La Paz
Department Name
Cardiology
Principal Investigator Name
Angel Manuel Iniesta Manjavacas
Principal Investigator Email
angelm.iniesta@salud.madrid.org
Contact Person Name
Angel Manuel Iniesta Manjavacas
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Cardiology
Principal Investigator Name
Rafael Jesus Hidalgo Urbano
Principal Investigator Email
rafaelj.hidalgo.sspa@juntadeandalucia.es
Contact Person Name
Rafael Jesus Hidalgo Urbano
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Cardiology
Principal Investigator Name
Esther Zorio Grima
Principal Investigator Email
zorio_est@gva.es
Contact Person Name
Esther Zorio Grima
Contact Person Email
zorio_est@gva.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Cardiology
Principal Investigator Name
Pablo Garcia Pavia
Principal Investigator Email
pablogpavia@cnic.es
Contact Person Name
Pablo Garcia Pavia
Contact Person Email
pablogpavia@cnic.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Cardiology
Principal Investigator Name
Julio Eduardo Nuñez Villota
Principal Investigator Email
inclivacardilogia@gmail.com
Contact Person Name
Julio Eduardo Nuñez Villota
Contact Person Email
inclivacardilogia@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Cardiology
Principal Investigator Name
Maria Crespo Leiro
Principal Investigator Email
marisa.crespo.leiro@sergas.es
Contact Person Name
Maria Crespo Leiro
Contact Person Email
marisa.crespo.leiro@sergas.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Cardiology
Principal Investigator Name
Antonio Bayes Genis
Principal Investigator Email
abayes.germanstrias@gencat.cat
Contact Person Name
Antonio Bayes Genis
Contact Person Email
abayes.germanstrias@gencat.cat
Site Name
Hospital Clinic De Barcelona
Department Name
Cardiology
Principal Investigator Name
Jose Ortiz Perez
Principal Investigator Email
JTORTIZ@clinic.cat
Contact Person Name
Jose Ortiz Perez
Contact Person Email
JTORTIZ@clinic.cat
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Cardiology
Principal Investigator Name
Marta De Antonio Ferrer
Principal Investigator Email
MAntonioF@santpau.cat
Contact Person Name
Marta De Antonio Ferrer
Contact Person Email
MAntonioF@santpau.cat
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Internal Medicine
Principal Investigator Name
Miguel Angel Aibar Arregui
Principal Investigator Email
maaibar@salud.aragon.es
Contact Person Name
Miguel Angel Aibar Arregui
Contact Person Email
maaibar@salud.aragon.es
Site Name
Bellvitge University Hospital
Department Name
Cardiology
Principal Investigator Name
Jose Gonzalez Costello
Principal Investigator Email
jgonzalez@bellvitgehospital.cat
Contact Person Name
Jose Gonzalez Costello
Site Name
Hospital Universitari Vall D Hebron
Department Name
Internal Medicine
Principal Investigator Name
Fernando Martinez Valle
Principal Investigator Email
fernando.martinez@vallhebron.cat
Contact Person Name
Fernando Martinez Valle
Site Name
Hospital Universitario Basurto
Department Name
Cardiology
Principal Investigator Name
Ainara Lozano Bahamonde
Principal Investigator Email
AINARA.LOZANOBAHAMONDE@osakidetza.eus
Contact Person Name
Ainara Lozano Bahamonde
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Cardiology
Principal Investigator Name
Antonio Garcia Quintana
Principal Investigator Email
agarquil@gobiernodecanarias.org
Contact Person Name
Antonio Garcia Quintana
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Cardiology
Principal Investigator Name
Paloma Remior Perez
Principal Investigator Email
paloma.remior@salud.madrid.org
Contact Person Name
Paloma Remior Perez
Contact Person Email
paloma.remior@salud.madrid.org

Netherlands

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
69
Number Of Sites
2
Number Of Participants
14

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Cardiology
Principal Investigator Name
Peter Van der Meer
Principal Investigator Email
p.van.der.meer@umcg.nl
Contact Person Name
Peter Van der Meer
Contact Person Email
p.van.der.meer@umcg.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Cardiology
Principal Investigator Name
Michelle Michels
Principal Investigator Email
m.michels@erasmusmc.nl
Contact Person Name
Michelle Michels
Contact Person Email
m.michels@erasmusmc.nl

Sponsor

Primary sponsor

Full Name
Novo Nordisk A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Contract research organisations

Name
Celerion Switzerland AG
Name
IQVIA Limited
Responsibilities
Patient interview
Name
Icon Clinical Research Limited
Responsibilities
Site and contract negotiation, Medical Imaging, In-home health, language services, Patient recruitement Materials.

Third parties

  • {"country":"United States","full_name":"Colorado Prevention Center","duties_or_roles":"Clinical outcome assessment","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Patient interview","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Site and contract negotiation, Medical Imaging, In-home health, language services, Patient recruitement Materials.","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
coramitug C 10035
Active Substance
CORAMITUG
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Orphan Designation
Yes
Investigational Product Name
liquid dosage form in 20 mL vials with 11 extractable volume
Modality
Other
Combination Treatment
Yes

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