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Coramitug

Phase 1

Transthyretin Amyloid Cardiomyopathy | Small molecule | Cardiovascular |Novo Nordisk A/S|Last Updated: Apr 13, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Coramitug · 1 trial · 1 indication

Phase 1 1
NCT07448623A 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.Transthyretin Amyloid Cardiomyopathy
RECRUITING14 Analytics
PHASE1RECRUITING
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.
Transthyretin Amyloid CardiomyopathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Standard Uptake Value Ratio (SUVRmean) in myocardium
Day 1-day 8

Measured as ratio.

Net uptake rate constant (Ki) in myocardium
0 to 168 hours

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

Change in SUVRmean in myocardium
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 Endpoints

Maximum Plasma Concentration (Cmax)
0 to 168 hours
Time at which maximum plasma concentration is observed (Tmax)
0 to 168 hours
Area under the curve (AUC)
0 to 168 hours
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALThe cohort includes participants that will be evaluated for the cardiac uptake of 89Zr coramitug.
Cohort 2EXPERIMENTALThe 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.

Interventions

NameTypeDescription
CoramitugDRUGCoramitug will be administered intravenously
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 a...

Countries:Netherlands
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Frequently asked questions about Coramitug

What is Coramitug used for?

Coramitug is an investigational small molecule being developed for transthyretin amyloid cardiomyopathy, a condition in which abnormal amyloid deposits accumulate in heart tissue. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes Coramitug?

Coramitug is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVO. The company is conducting a Phase 1 clinical trial to evaluate the drug's distribution and effects in people with ATTR amyloidosis.

What does Coramitug target?

Coramitug is designed to interact with amyloid deposits in heart tissue, as studied through PET/CT imaging in a clinical trial. The drug's mechanism involves targeting these deposits to assess their distribution and effects, though the specific molecular target has not been disclosed.

What phase is Coramitug in?

Coramitug is in Phase 1 clinical development. The ongoing trial, NCT07448623, is a controlled, open-label study recruiting participants in the Netherlands. As an investigational drug, it has not received FDA approval and remains in early-stage testing.

What clinical trials is Coramitug in?

Coramitug is being studied in one active Phase 1 clinical trial, NCT07448623, titled '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 trial is recruiting 14 participants aged 60 years and older in the Netherlands.

Is Coramitug the same as tafamidis?

Coramitug is not the same as tafamidis. Coramitug is a distinct investigational small molecule being developed by Novo Nordisk for transthyretin amyloid cardiomyopathy, while tafamidis is a separately approved treatment for the same condition. No alternative names for Coramitug have been identified.