NCT07448623

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.

An Open-label Study to Evaluate the Biodistribution of 89Zr-coramitug and Investigate the Effects of Coramitug on Depleting TTR Amyloid Deposits in Myocardial Tissues Using PET/CT Imaging in Participants With ATTR-CM

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

• Transthyretin Amyloid Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Coramitug	Coramitug will be administered intravenously

Timeline

• Start date: 2026-03-02
• Primary completion: 2027-05-30
• Completion: 2028-07-25
• First posted: 2026-03-04
• Last updated: 2026-04-13

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study