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
NCT ID: NCT05442047
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2022-08-02
2025-05-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
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
NCT07207811
The Effect of an Antisense Oligonucleotide to Lower Transthyretin (TTR) Levels on the Progression of -Wild-type TTR Involving the Heart
NCT02627820
Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy
NCT06393465
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
NCT05667493
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NNC6019-0001, Dose 1
Participants will receive dose 1 intravenous (i.v.) infusion of NNC6019-0001 every 4 weeks (Q4W) added to standard of care until week 52.
NNC6019-0001
Participants will receive i.v infusionof NNC6019-0001.
NNC6019-0001, Dose 2
Participants will receive dose 2 i.v. infusion of NNC6019-0001 Q4W added to standard of care until week 52.
NNC6019-0001
Participants will receive i.v infusionof NNC6019-0001.
Placebo
Participants will receive i.v. infusion of placebo (NNC6019-0001) Q4W added to standard of care until week 52.
Placebo (NNC6019-0001)
Participants will receive i.v. infusion of placebo (NNC6019-0001).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NNC6019-0001
Participants will receive i.v infusionof NNC6019-0001.
Placebo (NNC6019-0001)
Participants will receive i.v. infusion of placebo (NNC6019-0001).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Transparency 2834
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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-1
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
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, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Suhr OB, Grogan M, Silva AMD, Karam C, Garcia-Pavia P, Drachman B, Zago W, Tripuraneni R, Kinney GG. PRX004 in variant amyloid transthyretin (ATTRv) amyloidosis: results of a phase 1, open-label, dose-escalation study. Amyloid. 2025 Mar;32(1):14-21. doi: 10.1080/13506129.2024.2420809. Epub 2024 Oct 29.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1271-3861
Identifier Type: OTHER
Identifier Source: secondary_id
2021-006226-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN6019-4940
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.