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NCT Number: 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.

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON - location Groningen

Groningen, 9728 NZ, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • For participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM):
  • Have an established diagnosis of ATTR-CM, with either wild-type Transthyretin (TTR) or variant TTR genotype (ATTRwt) or (ATTRv), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, & heart failure (HF):

a) Cardiac amyloid infiltration demonstrated by: i. Cardiac biopsy positive for TTR amyloid, OR ii. Grade 2 or Grade 3 cardiac uptake at pyrophosphate/3,3-diphosphono-1,2-propanodicarboxylic acid/hydroxymethylene diphosphonate (PYP/DPD/HMDP) scintigraphy with Single-Photon Emission Computed Tomography (SPECT/CT) combined with an extracardiac biopsy positive for TTR amyloid, OR iii. Grade 2 or Grade 3 cardiac uptake at PYP/DPD/HMDP scintigraphy with SPECT/CT combined with normal serum free light chain ratio & negative serum & urine immunofixation (Serum Immunofixation [SPIE] and Urine Immunofixation [UPIE]) Note: Bone tracer scintigraphy using 99m technetium (Tc)-labelled pyrophosphate (99mTc-PYP)/99mTc-labelled 3,3-diphosphono-1,2- propanodicarboxylic acid (99mTc-DPD)/99mTc-labeled hydroxymethylene diphosphonate (99m-Tc-HMDP) b. Increased LV wall thickness, as assessed by echocardiography showing LV posterior and septal wall thickness greater than or equal to (≥)13 millimeter (mm) for women and ≥ 14 mm for men (Note: Pre-existing echocardiogram up to 2 years old can be used).

c. Chronic HF with: i. At least 1 documented hospitalisation for HF occurring greater than (>) 3 months but less than (<) 2 years, OR ii. History of HF manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath, signs of pulmonary con-gestion on x-ray or auscultation, or peripheral oedema) requiring ongoing treatment with a loop diuretic.

Exclusion criteria

  • 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.
  • Participation in research studies involving exposure to radiation within a year preceding the screening period in this study.

Treatment and study plan

Coramitug

Drug

Coramitug will be administered intravenously

Primary outcomes

  1. Mean Standard Uptake Value Ratio (SUVRmean) in myocardium

    Time frame: Day 1-day 8

    Measured as ratio.

  2. Net uptake rate constant (Ki) in myocardium

    Time frame: 0 to 168 hours

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

  3. Change in SUVRmean in myocardium

    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

    Measured as percentage (%).

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: 0 to 168 hours

    microcurie (μCi)

  2. Time at which maximum plasma concentration is observed (Tmax)

    Time frame: 0 to 168 hours

    Measured in hours.

  3. Area under the curve (AUC)

    Time frame: 0 to 168 hours

    Measured in microcurie *hours (μCi*h).

  4. Terminal half-life (T1/2)

    Time frame: 0 to 168 hours

    Measured in hours.

  5. Cmax

    Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2

    Measured in nanograms per milliliter (ng/mL).

  6. Tmax

    Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2

    Measured in hours.

  7. AUC

    Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2

    Measured in nanograms*hours per milliliter (ng*h/mL).

  8. T1/2

    Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2

    Measured in hours.

  9. Number of Treatment Emergent Adverse Events (TEAE)

    Time frame: From day 1 to day 8 in cohort 1 or day -1 to day 28 for cohort 2

    Measured as count of events.

  10. Number of Treatment Emergent Adverse Events

    Time frame: From baseline to week 52 (day 364), or week 64 (day 448) if there is no uptake expected/observed when both unradiolabelled and radiolabelled compounds are administered together

    Measured as count of events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 4, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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