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.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60+
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

Qualifiers

Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

Male or female.

Age greater than or equal to (≥) 60 years or above at the time of signing the informed consent.

Disqualifiers

Known or suspected hypersensitivity to study intervention(s) or related products.

Previous participation in this study. Participation is defined as signed informed consent.

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential.

Current participation (i.e., signed informed consent) in any other interventional clinical study.

Trial design

Treatments tested in this trial

  • Coramitug

Treatment groups

14 Participants
are divided into 2 treatment groups

Sponsors and collaborators