CLEOPATTRA
Research type
Research Study
Full title
Please note details entered here will be inserted into CWOW Clinical Dataset A3 CLEOPATTRA: Effects of NNC6019-0001 versus placebo on cardiovascular outcomes in participants with transthyretin amyloid cardiomyopathy (ATTR-CM)
IRAS ID
1012719
Contact name
Nadine McLeod
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
0000-000000-00
Research summary
Rationale: why are we doing the study?
This study is being conducted to determine whether a new medicine, called NNC6019-0001, may help treat a heart condition known as transthyretin (TTR) amyloid (ATTR) cardiomyopathy (ATTR-CM).
This condition happens when a protein made by the liver, called transthyretin, doesn’t form properly. When this faulty protein builds up in the heart, it can make the heart stiffer and weaker over time. This can lead to heart failure and other serious health problems.
We want to see if this new medicine can help reduce this buildup, improve heart health and reduce risk of complications in people with this condition.
Objectives and study endpoints: what do we want to find out and measure in the study?
Primary objective
Does NNC6019-0001 work better than placebo:
• For reducing deaths related to the heart and blood circulation
• For reducing repeated illness related to the heart and blood circulation
Key secondary objectives
Does NNC6019-0001 work better than placebo:
• For quality of life
• For reducing other signs of illness related to the heart and blood circulation
• For reducing time to death
• For reducing signs of kidney disease
Study population: who will take part in the study?
Worldwide, around 1280 men and women aged ≥18 years with chronic heart failure due to ATTR cardiomyopathy with confirmed cardiac amyloid infiltration will take part in this study. Participants must be able to complete the 6-minute walk test, with a distance of >50 meters during the initial screening test.
Study assessments: what procedures will the study staff do?
Participants will have up to 52 clinic visits. The medicine is given as a slow infusion into a vein in the arm. Participants will receive general health checks, including height, weight, blood pressure measurements, blood sampling, electrocardiograms, echocardiography, cardiac magnetic resonance imaging, questionnaires, 6-minute walk test.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0174
Date of REC Opinion
31 Oct 2025
REC opinion
Further Information Favourable Opinion