CLEOPATTRA: Effects of NNC6019-0001 Versus Placebo on Cardiovascular Outcomes in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Status: Recruiting
Location: See all (264) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female.

• Age 18 years or above at the time of signing the informed consent.

• Have an established diagnosis of ATTR-CM (wild-type ATTR \[ATTRwt\] or variant ATTR \[ATTRv\]), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF.

• Note: Target ATTRv recruitment is approximately 15 percent of the study population.

⁃ Cardiac amyloid infiltration demonstrated by:

∙ Cardiac biopsy positive for TTR amyloid, OR

‣ Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxymethylene diphosphonate (HMDP) scintigraphy with single-photon emission computed tomography (SPECT/CT) combined with an extracardiac biopsy positive for TTR amyloid, OR

‣ Grade 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:

‣ Non-invasive diagnostic pathway will be confirmed by a centralised expert review.

‣ Bone tracer scintigraphy will be conducted using 99m-technetium (Tc)-labelled pyrophosphate (99mTc-PYP), 99mTc-labelled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD), or 99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP).

⁃ Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm).

⁃ Chronic HF (New York Heart Association \[NYHA\] Class I-IV) requiring ongoing treatment with a loop diuretic with:

∙ At least 1 documented hospitalisation for HF, OR

‣ History 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).

‣ Expected to be on stable cardiovascular medical therapy (defined as no greater than 50 percent dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit.

‣ Completed more than 50 meters on the 6MWT at screening.

Locations
United States
Arizona
Mayo Clinic Hospital
NOT_YET_RECRUITING
Phoenix
California
University of California San Diego (UCSD) - Sulpizio Cardiovascular Center (SCVC)
NOT_YET_RECRUITING
La Jolla
Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)
NOT_YET_RECRUITING
Los Angeles
UCI Medical Center
NOT_YET_RECRUITING
Orange
Profound Research LLC at Southern California Heart Specialists
NOT_YET_RECRUITING
Pasadena
University of California, San Francisco Medical Center
NOT_YET_RECRUITING
San Francisco
Northbay Cardiology Inc.
RECRUITING
Santa Rosa
Lucile Packard Children's Hospital
NOT_YET_RECRUITING
Stanford
Connecticut
Yale University School of Medicine
NOT_YET_RECRUITING
New Haven
Washington, D.c.
MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center
NOT_YET_RECRUITING
Washington D.c.
Florida
UF Health Heart and Vascular Hospital
NOT_YET_RECRUITING
Gainesville
Georgia
Northeast Georgia Heart Center, Pc (Nghc)
NOT_YET_RECRUITING
Gainesville
Illinois
Northwestern University Clinical and Translational Sciences Institute
NOT_YET_RECRUITING
Chicago
The University of Chicago Medicine
NOT_YET_RECRUITING
Chicago
Endeavor Health - Glenbrook Hospital
NOT_YET_RECRUITING
Glenview
Indiana
Indiana University (IU) Health - Methodist Professional Center II
NOT_YET_RECRUITING
Indianapolis
Louisiana
LCMC - LSU University Medical Center New Orleans LCMC Center
NOT_YET_RECRUITING
New Orleans
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Tufts Medical Center (TMC) - Cancer Center
NOT_YET_RECRUITING
Boston
Maryland
John Hopkins Medicine
NOT_YET_RECRUITING
Baltimore
University of Maryland Medical Center (UMMC)
NOT_YET_RECRUITING
Baltimore
University of Maryland Medical Center (UMMC) - R Adams Cowley Shock Trauma Center
NOT_YET_RECRUITING
Baltimore
Michigan
University of Michigan Health System
NOT_YET_RECRUITING
Ann Arbor
Henry Ford Health
NOT_YET_RECRUITING
Detroit
Profound Research
NOT_YET_RECRUITING
Farmington Hills
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Missouri
Saint Luke's Hospital of Kansas City
NOT_YET_RECRUITING
Kansas City
Saint Louis University
NOT_YET_RECRUITING
St Louis
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
Mississippi
Cardiology Associates Research, LLc
NOT_YET_RECRUITING
Tupelo
North Carolina
Duke University Health System
NOT_YET_RECRUITING
Durham
Nebraska
University of Nebraska Medical Center
NOT_YET_RECRUITING
Omaha
New York
North Shore University Hospital, Northwell Health
NOT_YET_RECRUITING
Manhasset
Columbia University Medical Center
NOT_YET_RECRUITING
New York
Mount Sinai Medical Center
NOT_YET_RECRUITING
New York
New York University Medical Centre
NOT_YET_RECRUITING
New York
Weill Cornell Medical Center
NOT_YET_RECRUITING
New York
Laurelton Heart Specialist, PC
NOT_YET_RECRUITING
Rosedale
Ohio
The Carl and Edyth Lindner-Center for Research and Education at The Christ Hospital
NOT_YET_RECRUITING
Cincinnati
Oregon
Oregon Health and Science University
NOT_YET_RECRUITING
Portland
Pennsylvania
Abington Hospital - Jefferson Health
NOT_YET_RECRUITING
Abington
Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute
NOT_YET_RECRUITING
Hershey
Penn Medicine: University of Pennsylvania Health System
NOT_YET_RECRUITING
Philadelphia
University of Pittsburgh Medical Center (UPMC) - Center for Image-Guided Neurosurgery
NOT_YET_RECRUITING
Pittsburgh
South Carolina
Prisma Health
NOT_YET_RECRUITING
Greenville
Tennessee
Saint Thomas Health
NOT_YET_RECRUITING
Nashville
Texas
Ascension Seton Heart Institute - Medical Park Tower Location
NOT_YET_RECRUITING
Austin
St. Davids Heart and Vascular
NOT_YET_RECRUITING
Austin
Baylor Scott & White Research Institute - Annette C. and Harold C. Simmons Transplant Institute
NOT_YET_RECRUITING
Dallas
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
Baylor St. Luke Medical Center
NOT_YET_RECRUITING
Houston
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
Baylor Scott & White The Heart Hospital
NOT_YET_RECRUITING
Plano
Virginia
Inova Fairfax Hospital - Inova Heart and Vascular Institute
NOT_YET_RECRUITING
Falls Church
Sentara Cardiovascular Research Institute
NOT_YET_RECRUITING
Norfolk
Virginia Commonwealth University Medical Center
NOT_YET_RECRUITING
Richmond
Washington
University of Washington Medical Center - Montlake
NOT_YET_RECRUITING
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
NOT_YET_RECRUITING
Spokane
Other Locations
Australia
Central Adelaide Local Health Network - Royal Adelaide Hospital
NOT_YET_RECRUITING
Adelaide
Flinders Private Hospital
NOT_YET_RECRUITING
Adelaide
Victorian Heart Hospital
NOT_YET_RECRUITING
Clayton
ST Vincent's Hospital Sydney
NOT_YET_RECRUITING
Darlinghurst
Hobart Hospital-Royal Hobart Hospital
NOT_YET_RECRUITING
Hobart
Joondalup Cardiovascular Trials Foundation Inc.
NOT_YET_RECRUITING
Joondalup
Advara HeartCare - Leabrook
NOT_YET_RECRUITING
Leabrook
Liverpool Renal Clinical Research Centre
NOT_YET_RECRUITING
Liverpool
The Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Advara HeartCare - Milton
NOT_YET_RECRUITING
Milton
Fiona Stanley Hospital
NOT_YET_RECRUITING
Murdoch
Westmead Hospital
NOT_YET_RECRUITING
Westmead
Metro South Health - Princess Alexandra Hospital (PAH)
NOT_YET_RECRUITING
Woolloongabba
Belgium
AZORG Ziekenhuis
NOT_YET_RECRUITING
Aalst
Az Middelheim
NOT_YET_RECRUITING
Antwerp
Algemeen Ziekenhuis Sint-Jan
NOT_YET_RECRUITING
Bruges
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
NOT_YET_RECRUITING
Brussels
Universitair Ziekenhuis Brussel
NOT_YET_RECRUITING
Jette
Universitair Ziekenhuis Leuven
NOT_YET_RECRUITING
Leuven
Centre Hospitalier Regional CHR de la Citadelle
NOT_YET_RECRUITING
Liège
Algemeen Ziekenhuis Sint-Blasius (AZSB)
NOT_YET_RECRUITING
Sint-gillis-dendermonde
ZOL Genk, Campus Sint-Jan
NOT_YET_RECRUITING
Waterschei-zwartberg
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING
Woluwe-saint-lambert
Clinique Universitaire de Mont Godinne
NOT_YET_RECRUITING
Yvoir
Brazil
Cardresearch Cardiologia Assistencial e de Pesquisa Ltda
NOT_YET_RECRUITING
Belo Horizonte
NUPEC Cardio
NOT_YET_RECRUITING
Belo Horizonte
L2 IP - Instituto de Pesquisas Clinicas LTDA
NOT_YET_RECRUITING
Brasília
Synvia Laboratórios e Toxicologia Ltda - Synvia Clinical
NOT_YET_RECRUITING
Campinas
Universidade Estadual de Campinas - UNICAMP
NOT_YET_RECRUITING
Campinas
Universidade de Caxias do sul
NOT_YET_RECRUITING
Caxias Do Sul
Pontificia Universidade Catolica do Parana (PUCPR) - Centro de Ciencias Biologicas e da Saude (CCBS)
NOT_YET_RECRUITING
Curitiba
Hospital Moinhos de Vento
NOT_YET_RECRUITING
Porto Alegre
Instituto D'Or de Pesquisa e Ensino - Recife
NOT_YET_RECRUITING
Recife - Pe
Centro Avancado de Pesquisa-Estudo para-Diagnostico-CAPED
NOT_YET_RECRUITING
Ribeirão Preto
Instituto D'Or de Pesquisa e Ensino - Hospital Cardio Pulmonar (HCP)
NOT_YET_RECRUITING
Salvador
Instituto de Cardiologia Dante Pazzanese
NOT_YET_RECRUITING
São Paulo
Pseg Centro De Pesquisa Clinica S.A
NOT_YET_RECRUITING
São Paulo
Universidade de Sao Paulo (USP) Hospital das Clinicas da Faculdade de Medicina (HCFMUSP)
NOT_YET_RECRUITING
São Paulo
Eurolatino Pesquisas Medicas Ltda - (Eurolatino Medical Research - EMR)
NOT_YET_RECRUITING
Uberlândia
Canada
University of Calgary
NOT_YET_RECRUITING
Calgary
Health Sciences North Research Institute-Advanced Medical Research Institute of Canada
NOT_YET_RECRUITING
Greater Sudbury
Nova Scotia Health Authority
NOT_YET_RECRUITING
Halifax
Cardio Health Clinical Trials
NOT_YET_RECRUITING
Hamilton
London Health Sciences Centre - University Hospital
NOT_YET_RECRUITING
London
Cardio Health Clinical Trials
NOT_YET_RECRUITING
Mississauga
CIUSSS du Saguenay Lac-Saint-Jean
NOT_YET_RECRUITING
Québec
Hotel Dieu de Quebec
NOT_YET_RECRUITING
Québec
Cardiohealth Medical Clinic
NOT_YET_RECRUITING
Scarborough Village
Riverside Cardiology and Diagnostic Imaging
NOT_YET_RECRUITING
Toronto
Vancouver General Hospital
NOT_YET_RECRUITING
Vancouver
China
Beijing Hospital
NOT_YET_RECRUITING
Beijing
Beijing University Third Hospital
NOT_YET_RECRUITING
Beijing
FuWai Hospital, CAMS & PUMC
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
China-Japan Union Hospital
NOT_YET_RECRUITING
Changchun
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Xiangya Hospital
NOT_YET_RECRUITING
Changsha
The First Affiliated Hospital Of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Guangdong Academy of Medical Science (GAMS) - Guangdong General Hospital (GGH) - Guangdong Neuroscience Institute
NOT_YET_RECRUITING
Guangzhou
Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Affiliated Hospital of Guiyang Medical College
NOT_YET_RECRUITING
Guiyang
The First Affiliated Hospital, School of Medicine, ZheJiang University
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
Qi-Lu Hospital of Shandong University School of Medicine
NOT_YET_RECRUITING
Jinan
Shandong University School of Medicine - Shandong Provincial Hospital (SPH)
NOT_YET_RECRUITING
Jinan
Shengjing University Of China Medical University
NOT_YET_RECRUITING
Liaoning
The Second Affiliated Hospital Of Nanchang University
NOT_YET_RECRUITING
Nanchang
Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
NOT_YET_RECRUITING
Nanjing
Renji Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Jiao Tong University (SJTU) - Shanghai Chest Hospital (SCH)
NOT_YET_RECRUITING
Shanghaishi
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Medical University - First Hospital
NOT_YET_RECRUITING
Taiyuan
TEDA Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
NOT_YET_RECRUITING
Wuhan
Wuhan University - Renmin Hospital (Hubei General Hospital)
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Denmark
Aarhus Universitetshospital Skejby
NOT_YET_RECRUITING
Aarhus
Hjertecentret (The Heart Center)-Copenhagen University Hospital/Rigshosptalet
NOT_YET_RECRUITING
Copenhagen
Odense Universitetshospital
NOT_YET_RECRUITING
Odense C
France
Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud
NOT_YET_RECRUITING
Amiens
Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau
NOT_YET_RECRUITING
Chambray-lès-tours
Hospital Henri Mondor
NOT_YET_RECRUITING
Créteil
CHU De Dijon Hopital Du Bocage
NOT_YET_RECRUITING
Dijon
Centre Hospitalier Departemental Vendee (CHD) - L'Hopital de la Roche-sur-Yon (CHD Les Oudairies)
NOT_YET_RECRUITING
La Roche-sur-yon
Centre Hospitalier Universitaire de Grenoble (CHUG) Hopital Nord
NOT_YET_RECRUITING
La Tronche
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone
NOT_YET_RECRUITING
Marseille
Hospital Center Annecy Genevois-Centre Hospitalier de la Region d'Annecy CHRA
NOT_YET_RECRUITING
Metz-tessy
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
NOT_YET_RECRUITING
Montpellier
CHU De Nantes - Hopital Laennec
NOT_YET_RECRUITING
Nantes
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
NOT_YET_RECRUITING
Nice
Groupement Hospitalier Universitaire Ouest - Hopital Europeen Georges-Pompidou (HEGP)
NOT_YET_RECRUITING
Paris
Hopital Bichat - Claude-Bernard
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
NOT_YET_RECRUITING
Pessac
Centre Hospitalier Universitaire de Poitiers la Miletrie
NOT_YET_RECRUITING
Poitiers
Centre Hospitalier Universitaire (CHU) de Rennes
NOT_YET_RECRUITING
Rennes
Centre Hospitalier de Toulon - Hopital Sainte-Musse
NOT_YET_RECRUITING
Toulon
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
NOT_YET_RECRUITING
Toulouse
Private Hospital Medipole
NOT_YET_RECRUITING
Villeurbanne
Germany
Universitätsklinik Der Ruhr-Universität Bochum
NOT_YET_RECRUITING
Bad Oeynhausen
Charite - Universitaetsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Klinikum Bielefeld Mitte
NOT_YET_RECRUITING
Bielefeld
Universitaetsklinikum Koeln
NOT_YET_RECRUITING
Cologne
Universitatsklinikum Carl Gustav Carus
NOT_YET_RECRUITING
Dresden
University Heart Center Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
Universitatsklinikum Heidelberg
NOT_YET_RECRUITING
Heidelberg
Universitaetsklinikum Jena
NOT_YET_RECRUITING
Jena
Universitaetsklinikum Schleswig-Holstein
NOT_YET_RECRUITING
Kiel
Deutsches Herzzentrum Muenchen
NOT_YET_RECRUITING
München
University of Munich (LMU)-Grosshadern Hospital
NOT_YET_RECRUITING
Munich
Universitaetsklinikum Muenster
NOT_YET_RECRUITING
Münster
University of Wurzburg, Comprehensive Heart Failure Center (CHFC)
NOT_YET_RECRUITING
Würzburg
Italy
Policlinico S.Orsola Malpighi, Universita di Bologna
NOT_YET_RECRUITING
Bologna
Azienda Sanitaria del Sudtirol-Ospedale di Bolzano
NOT_YET_RECRUITING
Bolzano
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
NOT_YET_RECRUITING
Brescia
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco
NOT_YET_RECRUITING
Catania
Azienda Ospedaliera Universitaria Di Ferrara
NOT_YET_RECRUITING
Cona
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
NOT_YET_RECRUITING
Florence
Ospedale di Ivrea
NOT_YET_RECRUITING
Ivrea
Azienda Ospedaliera Universitaria Gaetano Martino Messina
NOT_YET_RECRUITING
Messina
ASST Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera San Paolo - Universita Degli Studi Di Milano
NOT_YET_RECRUITING
Milan
Centro Cardiologico Monzino IRCCS
NOT_YET_RECRUITING
Milan
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
NOT_YET_RECRUITING
Milan
Instituto Pio Albergo Trivulzio
NOT_YET_RECRUITING
Milan
Istituto Auxologico Italiano, IRCCS
NOT_YET_RECRUITING
Milan
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera dei Colli - Ospedale Monaldi
NOT_YET_RECRUITING
Napoli
Divisione di Cardiologia con Utic ed Emodinamica
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
NOT_YET_RECRUITING
Palermo
Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Universita degli Studi di Perugia
NOT_YET_RECRUITING
Perugia
Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica (Ftgm)
NOT_YET_RECRUITING
Pisa
Istituto Patologia Speciale Medica Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli
NOT_YET_RECRUITING
Rome
Ospedale Sant'Andrea Hospital
NOT_YET_RECRUITING
Rome
Polo Cardiologico - Ospedale Cattinara (ASUGI)
NOT_YET_RECRUITING
Trieste
Japan
Hyogo Prefectural Amagasaki General Medical Center
NOT_YET_RECRUITING
Amagasaki
Nippon Medical School Hospital
NOT_YET_RECRUITING
Bunkyo-ku
Saiseikai Fukuoka General Hospital
NOT_YET_RECRUITING
Fukuoka
Hyogo Prefectural Harima-Himeji General Medical Center
NOT_YET_RECRUITING
Himeji
Kitasato University - Kitasato University Hospital (KUH)
NOT_YET_RECRUITING
Kanagawa
Nara Medical University Hospital
NOT_YET_RECRUITING
Kashihara
Hospital of University of Occupational and Environmental Health
NOT_YET_RECRUITING
Kitakyushu
Kobe University Hospital
NOT_YET_RECRUITING
Kobe
Kumamoto University Hospital
NOT_YET_RECRUITING
Kumamoto
Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
NOT_YET_RECRUITING
Kumamoto
Kurume University - Research Center for Innovative Cancer Therapy
NOT_YET_RECRUITING
Kurume-shi
University Hospital Kyoto Prefectural University of Medicine
NOT_YET_RECRUITING
Kyoto
Shinshu University Hospital, Shinshu University Graduate School Of Medicine
NOT_YET_RECRUITING
Matsumoto
Nagasaki University Hospital
NOT_YET_RECRUITING
Nagasaki
Nagoya University Hospital
NOT_YET_RECRUITING
Nagoya
Kochi Medical School Hospital
NOT_YET_RECRUITING
Nankoku-shi
Osaka Metropolitan University Hospital
NOT_YET_RECRUITING
Osaka
Sapporo Medical University Hospital
NOT_YET_RECRUITING
Sapporo
National Cerebral and Cardiovascular Center
NOT_YET_RECRUITING
Suita
Keio University Hospital
NOT_YET_RECRUITING
Tokyo
Toyama Prefectural Central Hospital
NOT_YET_RECRUITING
Toyama
Mie University Hospital
NOT_YET_RECRUITING
Tsu
Uwajima City Hospital
NOT_YET_RECRUITING
Uwajima-shi
Yamaguchi University Hospital
NOT_YET_RECRUITING
Yamaguchi Prefecture
Showa University Fujigaoka Hospital
NOT_YET_RECRUITING
Yokohama
Netherlands
University Medical Center Groningen
NOT_YET_RECRUITING
Groningen
Maastricht University Medical Center (MUMC)
NOT_YET_RECRUITING
Maastricht
Erasmus Medisch Centrum 1
NOT_YET_RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht (UMC Utrecht)
NOT_YET_RECRUITING
Utrecht
Republic of Korea
Inje University Haeundae Paik Hospital
NOT_YET_RECRUITING
Busan
Inha University Hospital
NOT_YET_RECRUITING
Incheon
Seoul National University Bundang Hospital (SNUBH)
NOT_YET_RECRUITING
Seongnam-si
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Spain
Complejo Hospitalario Universitario A Coruna
NOT_YET_RECRUITING
A Coruña
Hospital Universitari Germans Trias i Pujol (HUGTP)
NOT_YET_RECRUITING
Badalona
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
NOT_YET_RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Universitario de Basurto
NOT_YET_RECRUITING
Bilbao
Hospital Universitario Reina Sofia
NOT_YET_RECRUITING
Córdoba
Hospital Universitario de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Doctor Negrin
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
NOT_YET_RECRUITING
Majadahonda
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
Hospital Son Llatzer (HSLL)
NOT_YET_RECRUITING
Palma De Mallorca
Hospital Clinico Universitario De Santiago De Compostela
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocio
NOT_YET_RECRUITING
Seville
Universidad de Sevilla - Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING
Seville
Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz
NOT_YET_RECRUITING
Úbeda
Fundacion Investigacion Clinico de Valencia (FIHCUV) - Instituto de Investigacion Sanitaria (INCLIVA)
NOT_YET_RECRUITING
Valencia
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
NOT_YET_RECRUITING
Valencia
Hospital Clinico Universitario Lozano Blesa de Zaragoza
NOT_YET_RECRUITING
Zaragoza
United Kingdom
Synexus Scotland Clinical Research Centre
NOT_YET_RECRUITING
Bellshill
Synexus Midlands Clinical Research Centre
NOT_YET_RECRUITING
Birmingham
Velocity Clinical Research, Bristol
NOT_YET_RECRUITING
Bristol
Synexus Wales Clinical Research Centre
NOT_YET_RECRUITING
Cardiff
Synexus North East Clinical Research Centre
NOT_YET_RECRUITING
Hexham
Synexus Merseyside Clinical Research Centre
NOT_YET_RECRUITING
Liverpool
Richmond Pharmacology - MHRA Phase 1 Unit
NOT_YET_RECRUITING
London
The Royal Free Hospital - Royal Free London NHS Foundation Trust
NOT_YET_RECRUITING
London
Synexus Manchester Clinical Research Centre
NOT_YET_RECRUITING
Manchester
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2029-06-29
Participants
Target number of participants: 1280
Treatments
Experimental: NNC6019-0001
Participants will receive NNC6019-0001 intravenously (IV). Participants will also have the option to continue any Standard of care (SoC) treatments as recommended by their medical health professional.
Placebo_comparator: Placebo
Participants will receive placebo matched to NNC6019-0001 IV. Participants will also have the option to continue any SoC treatments as recommended by their medical health professional.
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov