A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis

study id #: NCT06260709

condition: Transthyretin Amyloid Cardiomyopathy (ATTR CM)

status: Recruiting

This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called “A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis”. Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).

intervention: NNC6019-0001

results: https://clinicaltrials.gov/ct2/show/results/NCT06260709

last updated: March 10, 2024

start date: February 20, 2024

estimated completion: February 29, 2028

last updated: February 22, 2024

phase of development: Phase 2

size / enrollment: 80

primary outcomes:

• Number of Treatment Emergent Adverse Events
  Measured as events.
• From baseline (week 0) up to visit 39 (week 156)
  

secondary outcomes:

• Change in 6-Minute Walk Test (6MWT)
  From baseline (week 0) to visit 28 (week 104)
• Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
  From baseline (week 0) to visit 28 (week 104)
• Change in Myocardial Extracellular Volume (ECV)
  From baseline (week 0) to visit 28 (week 104)
• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
  From baseline (week 0) to visit 28 (week 104)
• Change in Troponin I
  From baseline (week 0) to visit 28 (week 104)
• Change in Global Longitudinal Strain (GLS) on Echocardiography
  From baseline (week 0) to visit 28 (week 104)

inclusion criteria:

exclusion criteria: Criteria:

A prior solid organ transplant.
Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
Body weight greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening.

sponsor: Novo Nordisk A/S

contacts: Novo Nordisk, (+1) 866-867-7178, [email protected]

investigators: Clinical Transparency (dept. 2834),Novo Nordisk A/S

trial center locations: United States,Canada,Czechia,France,Germany,Italy,Netherlands,Portugal,Spain

• United States, Arizona
  Mayo Clinic Arizona
  
  
• United States, California
  Cedars-Sinai Medical Center_Los Angeles
  
  
• United States, California
  Stanford Hlth Cre-Boswell Clin
  
  
• United States, Florida
  Mayo Clinic Jacksonville
  
  
• United States, Illinois
  NW Univ-Bluhm Cardiovasc Inst
  
  
• United States, Maryland
  Univ of MD Schl of Med
  
  
• United States, Minnesota
  Mayo Clinic Rochester
  
  
• Canada, Alberta
  University of Calgary_Cardiology
  
  
• Canada, British Columbia
  Ctr for Cardiovascular Innovation
  
  
• Czechia
  II. interni klinika VFN – Kardiologie a angiologie
  
  
• France
  Ap-Hp-Hopital Henri Mondor
  
  
• France
  Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
  
  
• Germany
  LMU Klinikum München Klinik und Poliklinik 1
  
  
• Germany
  Uniklinik Münster, Klinik für Kardiologie I
  
  
• Germany
  Universitatsklinikum Wurzburg AöR
  
  
• Germany
  Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
  
  
• Italy, PV
  Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
  
  
• Italy, Pi
  Fondazione CNR-Regione Toscana Gabriele Monasterio
  
  
• Netherlands
  UMC Groningen
  
  
• Netherlands
  Universitair Medisch Centrum Utrecht
  
  
• Portugal
  Centro Hospitalar de Trás-os-Montes e Alto Douro
  
  
• Portugal
  Hospital da Senhora da Oliveira – Guimarães
  
  
• Spain, Madrid
  Hospital Universitario Puerta de Hierro Majadahonda