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CLEOPATTRA: A Study of Coramitug (NNC6019-0001) for Heart Failure Due to Transthyretin Amyloid Amyloidosis

This study, called CLEOPATTRA, is testing a medicine named Coramitug (NNC6019-0001) to see if it can help people with heart failure caused by transthyretin amyloid cardiomyopathy (ATTR-CM). ATTR-CM is a condition where abnormal proteins build up in the heart. You would either receive Coramitug or a placebo (a treatment with no active medicine), decided by chance. The study aims to see if Coramitug can reduce the risk of heart-related deaths and hospitalizations. You must be at least 18 years old and have a confirmed diagnosis of ATTR-CM with heart involvement. The study plans to enroll 1280 participants, but its current status is unclear.

Study design
This study is an interventional trial planning to enroll 1280 participants. You would be randomly assigned to receive either the study drug NNC6019-0001 or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health outcomes, including heart-related deaths and hospitalizations, will be monitored for up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07207811

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis

Recruiting
PHASE3Ages 18+InterventionalTreatment
Novo Nordisk A/S
~1,280 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:NNC6019-0001Placebo (NNC6019-0001)

At a glance

Recruiting sites
197 of 295 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Outcome of cardiovascular (CV) deaths and recurrent CV events (CV hospitalisations and urgent heart failure [HF] visits)
Measured over From baseline (week 0) to end of study (EOS) (up to approximately 4 years)

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Explore related trials

Transthyretin related familial amyloid cardiomyopathy

NCT07207811

Where you'd take part

This study runs at 295 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aarhus Universitetshospital Skejby

    Aarhus, Central Jutland, Denmarkno site contact published

    Recruiting

  • Algemeen Ziekenhuis Sint-Blasius (AZSB)

    Sint-Gillis-Dendermonde, Oost-Vlaanderen, Belgiumno site contact published

    Not yet recruiting

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, Belgiumno site contact published

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, Chinano site contact published

    Recruiting

  • Ascension Texas Cardiovascular Research Institute

    Austin, Texasno site contact published

    Recruiting

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone

    Marseille, Franceno site contact published

    Recruiting

  • ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco

    Lecco, Italyno site contact published

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italyno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

Novo Nordisk
[email protected]
(+1) 866-867-7178
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Composite Outcome of cardiovascular (CV) deaths and recurrent CV events (CV hospitalisations and urgent heart failure [HF] visits)From baseline (week 0) to end of study (EOS) (up to approximately 4 years)

    Measured as count of events.