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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Coramitug

    Drug

    Coramitug will be administered intravenously

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean Standard Uptake Value Ratio (SUVRmean) in myocardium

Measured as ratio.

Time frame
Day 1-day 8
2

Net uptake rate constant (Ki) in myocardium

Measured as milliliter per minute per centimeter cube (mL/min/cm\^3).

Time frame
0 to 168 hours
3

Change in SUVRmean in myocardium

Measured as percentage (%).

Time frame
From baseline to week 52 (day 364), or week 60 (day 420) if there is no uptake expected/observed when both unradiolabelled and radiolabelled compounds are administered together

Secondary outcomes

1

Maximum Plasma Concentration (Cmax)

microcurie (μCi)

Time frame
0 to 168 hours
2

Time at which maximum plasma concentration is observed (Tmax)

Measured in hours.

Time frame
0 to 168 hours
3

Area under the curve (AUC)

Measured in microcurie \*hours (μCi\*h).

Time frame
0 to 168 hours
4

Terminal half-life (T1/2)

Measured in hours.

Time frame
0 to 168 hours

Other outcomes

Sponsors and contacts

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