A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Transthyretin Amyloid Cardiomyopathy (ATTR CM)

In brief

This study is testing a potential new medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis.The study will look at if this medicine can reduce the symptoms of a heart disease due to TTR amyloidosis, such as heart failure. Participants will either get NNC6019-0001 (apotential new medicine) or placebo (a medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting NNC6019-0001 is two times higher than getting placebo. NNC6019-0001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe yet. Participants will get an infusion of the study medicine 13 times, once every 4 weeks. The study will last for about 64 weeks after the first dose of medicine. Participants cannot participate in this study if they have a heart disease other than a heart disease due to TTR amyloidosis.

Key facts

Study ID: NCT05442047
Run by: Novo Nordisk A/S
People needed: 105
Starts: 2022-08-02
Expected to finish: 2025-05-13
Last updated by the study team: 2026-02-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female.
Age greater than or equal to (>=) 18 to less than (<) 85 years at the time of signing informed consent.
Have an established diagnosis of Transthyretin amyloid cardiomyopathy (ATTR CM) with either wild-type transhyretin (TTR) or hereditary transthyretin (TTR) genotype as per local standards.
Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the randomisation visit.
Known end-diastolic interventricular septal wall thickness greater than or equal to (>=) 12 millimeters (mm).
Presently classified as New York Heart Association (NYHA) Class II-III.
N-terminal-pro brain natriuretic peptide (NT-proBNP) concentration greater than or equal to (>=) 650 picograms per milliliter (pg/mL) in sinus cardiac rhythm and greater than (>) 1000 pg/mL in atrial fibrillation at screening.
Completed greater than or equal to (>=) 150 meters to less than or equal to (<=) 450 meters on the 6-minute walk test (MWT) at screening.
Estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 25 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) at screening.

You may not qualify if…

Cardiomyopathy not primarily caused by transthyretin amyloid cardiomyopathy transthyretin amyloid cardiomyopathy (ATTR CM), for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease.
A prior solid organ transplant.
Planned solid organ transplant during the study.
Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu 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 (example [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.
Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac valve repair, or major surgery within 3 months of screening.
Body weight >120 kilogram (kg) (264.6 pounds [lb]) at screening.
History of contrast allergy or adverse reactions to gadolinium-containing agents.

Where it is running

Mayo Clinic Arizona — Phoenix, Arizona, United States
Cedars-Sinai Medical Center_Los Angeles — Beverly Hills, California, United States
Stanford Hlth Cre-Boswell Clin — Stanford, California, United States
Mayo Clinic Jacksonville — Jacksonville, Florida, United States
NW Univ-Bluhm Cardiovasc Inst — Evanston, Illinois, United States
Univ of MD Schl of Med — Baltimore, Maryland, United States
University of Maryland School of Medicine — Baltimore, Maryland, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
Oregon Hlth Sci Univ-Portland — Portland, Oregon, 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 — Toulouse, France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 — Toulouse Cedex 9 TSA 50032, France
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie — Heidelberg, Germany
LMU Klinikum München Klinik und Poliklinik 1 — München, Germany
Universitätsklinikum Münster - Klinik für Kardiologie I — Münster, Germany
Universitatsklinikum Wurzburg AöR — Würzburg, Germany
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz — Würzburg, Germany
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
Hospital of the University of Occupational and Environmental Health — Fukuoka, Japan
Hiroshima University hospital, Cardiovascular Medicine — Hiroshima, Japan

Full record on ClinicalTrials.gov

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