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

NCT06260709 · tracked via the Priya Life Science USA tracker

Sponsor

Novo Nordisk A/S

Phase

Phase 2

Started

2024-02-20

Last updated

2025-11-25

Condition(s) studied

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Investigational drug(s) / intervention(s)

NNC6019-0001

NNC6019-0001: Intravenous NNC6019-0001 every 4 weeks added to the standard of care until Week 140.

Study 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

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

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 outcome measure(s)

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

Trial sites (35)

Facility	City	Region
Mayo Clinic Arizona	Phoenix	Arizona
Cedars-Sinai Medical Center_Los Angeles	Los Angeles	California
Stanford Hlth Cre-Boswell Clin	Stanford	California
Mayo Clinic Jacksonville	Jacksonville	Florida
NW Univ-Bluhm Cardiovasc Inst	Chicago	Illinois
NW Univ-Bluhm Cardiovasc Inst	Evanston	Illinois
Univ of MD Schl of Med	Baltimore	Maryland
Mayo Clinic Rochester	Rochester	Minnesota
University of Calgary_Cardiology	Calgary	Alberta
Ctr for Cardiovascular Innovation	Vancouver	British Columbia
II. interni klinika VFN - Kardiologie a angiologie	Prague	Czechia
Ap-Hp-Hopital Henri Mondor	Créteil	France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1	Toulouse	France
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie	Heidelberg	Germany
Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie	Heidelberg	Germany
LMU Klinikum München Klinik und Poliklinik 1	München	Germany
Uniklinik Münster, Klinik für Kardiologie I	Münster	Germany
Universitätsklinikum Münster - Klinik für Kardiologie I	Münster	Germany
Universitatsklinikum Wurzburg AöR	Würzburg	Germany
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz	Würzburg	Germany
Fondazione CNR-Regione Toscana Gabriele Monasterio	Pisa	Pi
Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare	Pisa	Pi
Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo	Pavia	PV
Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology	Fukuoka	Japan
Hiroshima University hospital, Cardiovascular Medicine	Hiroshima	Japan
Kumamoto University Hospital, Cardiovascular Medicine	Kumamoto-shi, Kumamoto	Japan
Shinshu University Hospital, Department of Neurology	Nagano	Japan
Nagasaki University Hospital, Cardiovascular Medicine	Nagasaki	Japan
Okayama University Hospital_Cardiovascular Medicine	Okayama-shi, Okayama	Japan
UMC Groningen	Groningen	Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	Netherlands
Hospital da Senhora da Oliveira - Guimarães	Guimarães	Portugal
Unidade Local de Saude do Alto Ave, E.P.E.	Guimarães	Portugal
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.	Vila Real	Portugal
Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid

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Other trials for the same condition

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06260709 on ClinicalTrials.gov ↗ ← All trials in the USA