RecruitingPhase 3

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

United States1,280 participantsStarted 2025-10-02

Plain-language summary

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Cardiac amyloid infiltration demonstrated by:
✓. Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm).
✓. Chronic HF (New York Heart Association \[NYHA\] Class I-IV):

What they're measuring

Composite Outcome of cardiovascular (CV) deaths and recurrent CV events (CV hospitalisations and urgent heart failure [HF] visits)

Timeframe: From baseline (week 0) to end of study (EOS) (up to approximately 4 years)

Trial details

NCT IDNCT07207811

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06-29

Contact for this trial

Novo Nordisk

(+1) 866-867-7178 clinicaltrials@novonordisk.com

View on ClinicalTrials.gov More Transthyretin Amyloid Cardiomyopathy (ATTR CM) trials