Transthyretin Amyloid CardiomyopathyPhase 1NCT07448623
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.
A Phase 1 study testing Coramitug in people with Transthyretin Amyloid Cardiomyopathy, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy
- What is being tested?
- Coramitug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Mar 2026to 25 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- 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).
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
ICON - location Groningen
Groningen, 9728 NZ
About this study
Official 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
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
- Being tested
- Coramitug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoramitugDrug
Coramitug will be administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | The cohort includes participants that will be evaluated for the cardiac uptake of 89Zr coramitug. Receives: Drug: Coramitug |
| Cohort 2 | Experimental | 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. Receives: Drug: Coramitug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Standard Uptake Value Ratio (SUVRmean) in myocardium
Measured as ratio.
Measured: Day 1-day 8
Net uptake rate constant (Ki) in myocardium
Measured as milliliter per minute per centimeter cube (mL/min/cm^3).
Measured: 0 to 168 hours
Change in SUVRmean in myocardium
Measured as percentage (%).
Measured: 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 (10)
Maximum Plasma Concentration (Cmax)
microcurie (μCi)
Measured: 0 to 168 hours
Time at which maximum plasma concentration is observed (Tmax)
Measured in hours.
Measured: 0 to 168 hours
Area under the curve (AUC)
Measured in microcurie *hours (μCi*h).
Measured: 0 to 168 hours
Terminal half-life (T1/2)
Measured in hours.
Measured: 0 to 168 hours
Cmax
Measured in nanograms per milliliter (ng/mL).
Measured: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
Tmax
Measured in hours.
Measured: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
AUC
Measured in nanograms*hours per milliliter (ng*h/mL).
Measured: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
T1/2
Measured in hours.
Measured: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
Number of Treatment Emergent Adverse Events (TEAE)
Measured as count of events.
Measured: From day 1 to day 8 in cohort 1 or day -1 to day 28 for cohort 2
Number of Treatment Emergent Adverse Events
Measured as count of events.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start2 Mar 2026
- Primary completion30 May 2027 (estimated)
- Study completion25 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Amyloid CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448623
- Sponsor's protocol ID
- NN6019-7853
- Other IDs
- U1111-1316-9198, 2024-519372-22
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07448623
- Acronym / sponsor ID
- NN6019-7853
- Conditions
- Transthyretin Amyloid Cardiomyopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 25 Jul 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CoramitugThe cohort includes participants that will be evaluated for the cardiac uptake of 89Zr coramitug. |
| Cohort 2 | Experimental | Drug: CoramitugThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoramitugCoramitug will be administered intravenously | Drug | Cohort 1, Cohort 2 |
Primary outcome
Mean Standard Uptake Value Ratio (SUVRmean) in myocardium
Time frame: Day 1-day 8
Measured as ratio.
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).
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 (%).
10 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: 0 to 168 hours
Time at which maximum plasma concentration is observed (Tmax)
Time frame: 0 to 168 hours
Area under the curve (AUC)
Time frame: 0 to 168 hours
Terminal half-life (T1/2)
Time frame: 0 to 168 hours
Cmax
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
Tmax
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
AUC
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
T1/2
Time frame: 0 to 168 hours for cohort 1, 0 to 672 hours for cohort 2
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Transthyretin Amyloid Cardiomyopathy
Not yet recruitingObservational study
PET/CT Imaging in Carriers of TTR Mutations
ATTR, ATTR Gene Mutation
Not yet recruitingObservational study
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Not yet recruitingPhase 2
Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
Transthyretin Cardiac Amyloidosis
Not yet recruitingObservational study
PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
Amyloidogenic Transthyretin (ATTR) Amyloidosis, Cardiac Amyloidosis
Active, not recruitingPhase 3
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Transthyretin Amyloid Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Coramitug in people with Transthyretin Amyloid Cardiomyopathy, run by Novo Nordisk A/S at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Standard Uptake Value Ratio (SUVRmean) in myocardium (time frame: Day 1-day 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.