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.

Sponsor
Novo Nordisk A/S
Study ID
NCT07448623
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Coramitug — DRUG
    Coramitug will be administered intravenously

Study Details

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.

Key Dates

Start date
Mar 2, 2026
Status verified
Apr 2026
Primary completion
May 30, 2027
Completion
Jul 25, 2028

Study Design

Enrollment
14 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    The cohort includes participants that will be evaluated for the cardiac uptake of 89Zr coramitug.
  • Experimental: Cohort 2
    The cohort includes participants to evaluate the sink effect (if observed in cohort 1) and also evaluate competitive binding between 89Zr-coramitug and different dose levels of coramitug.

Primary Outcome Measure

Mean Standard Uptake Value Ratio (SUVRmean) in myocardium [ Time Frame: Day 1-day 8 ]

Central Contacts

Related Studies