At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- NNC6019-0001 (drug), Placebo (NNC6019-0001) (drug)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- NNC6019-0001 — drug: NNC6019-0001 will be administered IV. · Placebo (NNC6019-0001) — drug: Placebo matched to NNC6019-0001 will be administered IV.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,280
- Started
- 2025-10-02
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for transthyretin amyloid cardiomyopathy (attr cm)
- • Phase3 - 1,280 participants
- • This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with transthyretin amyloid cardiomyopathy (attr cm)
Where?
- • London - The Royal Free Hospital - Royal Free London NHS Foundation Trust
- • Manchester - Synexus Manchester Clinical Research Centre
- • Bellshill - Synexus Scotland Clinical Research Centre
- • Birmingham - Synexus Midlands Clinical Research Centre
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ or requires ongoing treatment with a diuretic)
What the study is looking for
- ✓Male or female.
- ✓Age 18 years or above at the time of signing the agreement to take part.
- ✓Have an established diagnosis of ATTR-CM (wild-type ATTR \[ATTRwt\] or variant ATTR \[ATTRv\]), with heart amyloid...
- ✓Note: Target ATTRv recruitment is approximately 15 percent of the study population.
- ✓Notes:
Who cannot take part
- ✗Known or suspected hypersensitivity to study intervention(s) or related products.
- ✗Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting...
- ✗Total liver blood test greater than 3 times the upper limit of normal (ULN) at screening.
- ✗Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis, known leptomeningeal amyloidosis,...
- ✗HF not primarily caused by ATTR-CM (e.g., due to hypertension, valvular heart disease, or ischemic heart disease in...
See the full criteria
Where Is This Study? (7 UK sites)
The Royal Free Hospital - Royal Free London NHS Foundation Trust
London NW3 2QG, United Kingdom
Synexus Manchester Clinical Research Centre
Manchester M15 6SE, United Kingdom
Synexus Scotland Clinical Research Centre
Bellshill ML4 3NJ, United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham B15 2SQ, United Kingdom
Synexus Wales Clinical Research Centre
Cardiff CF15 9SS, United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool L22 0LG, United Kingdom
Richmond Pharmacology - MHRA Phase 1 Unit
London SE1 1YR, United Kingdom
How to Get in Touch
Novo Nordisk
Sponsor contactCONTACT
