Actively Recruiting
A Research Study to Look at the Distribution and Effects of Coramitug on Amyloid Deposits in Heart Tissue Using PET/CT Imaging in People With ATTR Amyloidosis.
Led by Novo Nordisk A/S · Updated on 2026-04-13
14
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is conducted in participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM), a heart disease that occurs in people with the disease ATTR amyloidosis. The purpose of this study is to see how radioactively labelled coramitug is taken up by the heart after administration through an infusion (Cohort 1), and to understand the extent to which coramitug can be displaced by radioactively labelled coramitug (Cohort 2). In this study it will also be investigated how safe coramitug is and how well it is tolerated when it is used by participants with ATTR-CM. Coramitug is potentially a new medicine for participants with ATTR-CM. Coramitug is a monoclonal antibody that potentially binds to the accumulations of the transthyretin protein and promotes its removal from the heart. It may also prevent the formation of clumps and may help with clearing existing clumps of the abnormal protein. The study will take a maximum of 85 days (for Cohort 1) or 106 days (for Cohort 2) when participating in Period A from the screening until the follow-up visit.
CONDITIONS
Official Title
A Research Study to Look at the Distribution and Effects of Coramitug on Amyloid Deposits in Heart Tissue Using PET/CT Imaging in People With ATTR Amyloidosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study activities
- Male or female participants
- Age 60 years or older at the time of consent
- Established diagnosis of Transthyretin Amyloid Cardiomyopathy (ATTR-CM) with wild-type or variant transthyretin genotype
- Cardiac amyloid infiltration confirmed by biopsy or bone tracer scintigraphy with SPECT/CT
- Increased left ventricular wall thickness (≥13 mm for women, ≥14 mm for men) by echocardiography
- Chronic heart failure with either hospitalization for heart failure within past 3 months to 2 years or ongoing heart failure symptoms requiring loop diuretics
You will not qualify if you...
- Known or suspected allergy to the study drug or related products
- Previous participation in this study
- Female who is pregnant, breastfeeding, or planning pregnancy or is of childbearing potential
- Current participation in any other interventional clinical trial
- Participation in studies with radiation exposure within one year before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ICON - location Groningen
Groningen, Netherlands, 9728 NZ
Actively Recruiting
Research Team
N
Novo Nordisk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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