Clinical trial NCT06260709: 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
Official title: Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-02-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16.
* Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.

Exclusion 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.

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events
timeFrame: From baseline (week 0) up to visit 39 (week 156)
Secondary outcomes:
measure: Change in 6-Minute Walk Test (6MWT)
timeFrame: From baseline (week 0) to visit 28 (week 104)
measure: Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
timeFrame: From baseline (week 0) to visit 28 (week 104)
measure: Change in Myocardial Extracellular Volume (ECV)
timeFrame: From baseline (week 0) to visit 28 (week 104)
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
timeFrame: From baseline (week 0) to visit 28 (week 104)
measure: Change in Troponin I
timeFrame: From baseline (week 0) to visit 28 (week 104)
measure: Change in Global Longitudinal Strain (GLS) on Echocardiography
timeFrame: From baseline (week 0) to visit 28 (week 104)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center_Los Angeles
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center_Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford Hlth Cre-Boswell Clin
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Chicago
country: United States
facility: NW Univ-Bluhm Cardiovasc Inst
state: Illinois
city: Evanston
country: United States
facility: NW Univ-Bluhm Cardiovasc Inst
state: Illinois
city: Baltimore
country: United States
facility: Univ of MD Schl of Med
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Calgary
country: Canada
facility: University of Calgary_Cardiology
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary_Cardiology
state: Alberta
city: Vancouver
country: Canada
facility: Ctr for Cardiovascular Innovation
state: British Columbia
city: Vancouver
country: Canada
facility: Ctr for Cardiovascular Innovation
state: British Columbia
city: Praha 2
country: Czechia
facility: II. interni klinika VFN - Kardiologie a angiologie
city: Praha 2
country: Czechia
facility: II. interni klinika VFN - Kardiologie a angiologie
city: Créteil
country: France
facility: Ap-Hp-Hopital Henri Mondor
city: Créteil
country: France
facility: Ap-Hp-Hopital Henri Mondor
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
city: München
country: Germany
facility: LMU Klinikum München Klinik und Poliklinik 1
city: München
country: Germany
facility: LMU Klinikum München Klinik und Poliklinik 1
city: Münster
country: Germany
facility: Uniklinik Münster, Klinik für Kardiologie I
city: Münster
country: Germany
facility: Uniklinik Münster, Klinik für Kardiologie I
city: Würzburg
country: Germany
facility: Universitatsklinikum Wurzburg AöR
city: Würzburg
country: Germany
facility: Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
city: Pisa
country: Italy
facility: Fondazione CNR-Regione Toscana Gabriele Monasterio
state: Pi
city: Pisa
country: Italy
facility: Fondazione CNR-Regione Toscana Gabriele Monasterio
state: Pi
city: Pavia
country: Italy
facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
state: PV
city: Pavia
country: Italy
facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
state: PV
city: Fukuoka
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology
city: Hiroshima
country: Japan
facility: Hiroshima University hospital, Cardiovascular Medicine
city: Kumamoto-shi, Kumamoto
country: Japan
facility: Kumamoto University Hospital, Cardiovascular Medicine
city: Nagano
country: Japan
facility: Shinshu University Hospital, Department of Neurology
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital, Cardiovascular Medicine
city: Okayama-shi, Okayama
country: Japan
facility: Okayama University Hospital_Cardiovascular Medicine
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira - Guimarães
city: Guimarães
country: Portugal
facility: Unidade Local de Saude do Alto Ave, E.P.E.
city: Vila Real
country: Portugal
facility: Centro Hospitalar de Trás-os-Montes e Alto Douro
city: Vila Real
country: Portugal
facility: Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: