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
Running, not enrolling · Phase 2
Conditions studied: Transthyretin Amyloid Cardiomyopathy (ATTR CM)
In brief
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).
Key facts
- Study ID
- NCT06260709
- Run by
- Novo Nordisk A/S
- People needed
- 80
- Starts
- 2024-02-20
- Expected to finish
- 2028-08-15
- Last updated by the study team
- 2025-11-25
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic Arizona — Phoenix, Arizona, United States
- Cedars-Sinai Medical Center_Los Angeles — Los Angeles, California, United States
- Stanford Hlth Cre-Boswell Clin — Stanford, California, United States
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States
- NW Univ-Bluhm Cardiovasc Inst — Chicago, Illinois, United States
- NW Univ-Bluhm Cardiovasc Inst — Evanston, Illinois, United States
- Univ of MD Schl of Med — Baltimore, Maryland, United States
- Mayo Clinic Rochester — Rochester, Minnesota, United States
- University of Calgary_Cardiology — Calgary, Alberta, Canada
- Ctr for Cardiovascular Innovation — Vancouver, British Columbia, Canada
- 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, Italy
- Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare — Pisa, Pi, Italy
- Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo — Pavia, PV, Italy
- Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology — Fukuoka, Japan
- Hiroshima University hospital, Cardiovascular Medicine — Hiroshima, Japan
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.