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Coramitug (NNC6019-0001) for heart failure from transthyretin amyloid cardiomyopathy

CLEOPATTRA: Effects of NNC6019-0001 Versus Placebo on Cardiovascular Outcomes in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Phase 3 Interventional Novo Nordisk A/S · NCT07207811

This study tests whether coramitug (NNC6019-0001) can lower the risk of heart-related death and illness in adults with transthyretin amyloid cardiomyopathy (ATTR-CM) while they continue their usual heart medicines.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1280 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations289 sites (Phoenix, Arizona and 288 other locations)
Trial IDNCT07207811 on ClinicalTrials.gov

What this trial studies

CLEOPATTRA is a randomized, double-blind, placebo-controlled Phase 3 trial comparing coramitug to placebo in adults with ATTR-CM. Participants are randomly assigned to receive coramitug or matching placebo in addition to their standard heart failure therapies, and neither participants nor investigators know the assignment. The primary goal is to see if coramitug reduces a composite of heart-related death and cardiovascular-related illness, with secondary measures likely including hospitalizations, functional status, and safety. The study enrolls both wild-type and variant ATTR patients, targeting about 15% with variant ATTR, and is being conducted at multiple U.S. academic centers.

Who should consider this trial

Good fit: Adults (18+) with confirmed ATTR-CM—demonstrated by cardiac biopsy or grade 2–3 cardiac uptake on PYP/DPD/HMDP imaging with supporting testing—and evidence of heart failure and increased left ventricular wall thickness are ideal candidates.

Not a fit: People without ATTR-CM (for example those with light-chain amyloidosis), those with medical conditions that make the study drug unsafe, or those unable to attend required visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, coramitug could lower heart-related deaths and hospitalizations and slow progression of heart failure in people with ATTR-CM.

How similar studies have performed: Other TTR-targeting treatments such as tafamidis and RNA-silencing therapies have shown benefit in ATTR-CM, but coramitug represents a novel approach that has been less widely tested to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female.
* Age 18 years or above at the time of signing the informed consent.
* Have an established diagnosis of ATTR-CM (wild-type ATTR \[ATTRwt\] or variant ATTR \[ATTRv\]), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF.

Note: Target ATTRv recruitment is approximately 15 percent of the study population.

1. Cardiac amyloid infiltration demonstrated by:

   * Cardiac biopsy positive for TTR amyloid, OR
   * Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxymethylene diphosphonate (HMDP) nuclear medicine imaging with single-photon emission computed tomography (SPECT) or SPECT/CT (preferably) combined with an extracardiac biopsy positive for TTR amyloid, OR
   * Grade 2 or 3 cardiac uptake at PYP/DPD/HMDP nuclear medicine imaging with SPECT or SPECT/CT (preferably) combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE \& UPIE)/or mass spectrometry based methods including mass fixation).

   Notes:
   * Non-invasive diagnostic pathway will be confirmed by a centralised expert review.
   * Bone tracer nuclear medicine imaging with SPECT or SPECT/CT (preferably) will be conducted using 99m-technetium (Tc)-labelled pyrophosphate (99mTc-PYP), 99mTc-labelled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD), or 99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP).
   * The eGFR adjusted acceptable serum free light chain ratio.
   * Patients with Grade 2 or 3 cardiac uptake at PYP/DPD/HDMP nuclear imaging with SPECT or SPECT/CT (preferably) and evidence of monoclonal gammopathy of undetermined significance (MGUS; based on serum and urine protein electrophoresis and serum free light chains) will require endomyocardial biopsy with typing using mass spectrometry or immunohistochemistry to confirm presence of TTR protein in tissue.
   * Timing of serum free light chain ratio, SPIE, UPIE and mass spectrometry-based methods including mass fixation should be within 12 months of SPECT or SPECT/CT nuclear imaging.
2. Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm).
3. Chronic HF (New York Heart Association \[NYHA\] Class I-IV):

   * At least 1 documented hospitalisation for HF, OR
   * 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 congestion on x-ray or auscultation, or peripheral oedema that required or requires ongoing treatment with a diuretic).
   * Expected to be on stable cardiovascular medical therapy (defined as no greater than 50 percent dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit.
   * Completed more than 50 meters on the 6MWT at screening.

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.
* Total bilirubin greater than 3 times the upper limit of normal (ULN) at screening.
* Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis, known leptomeningeal amyloidosis, or multiple myeloma.
* HF not primarily caused by ATTR-CM (e.g., due to hypertension, valvular heart disease, or ischemic heart disease in the opinion of the investigator).
* Currently hospitalised or hospitalised within 14 days prior to screening.
* Currently treated with positive inotropic medication.
* Uncorrected, severe, haemodynamically significant, left-sided heart valve disease.
* Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 60 days of screening.
* Prior solid organ transplant or planned solid organ transplant during the study.
* Left ventricular ejection fraction (LVEF) less than 30 percent as assessed by centralised review of echocardiography.
* Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, carcinoma in situ/high-grade prostatic intraepithelial neoplasia \[PIN\], low-risk prostate cancer, or on stable therapy for prostate cancer) within 3 years before screening.
* End-stage renal disease (estimated glomerular filtration rate \[eGFR\] less than 15 mL/min/1.73 m\^2 at screening, or chronic/intermittent haemodialysis or peritoneal dialysis).

Where this trial is running

Phoenix, Arizona and 288 other locations

+239 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Transthyretin Amyloid Cardiomyopathy
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.