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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

ConditionTransthyretin Amyloid Cardiomyopathy (ATTR CM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Non-invasive diagnostic pathway will be confirmed by a centralised expert review.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NNC6019-0001

    Drug

    NNC6019-0001 will be administered IV.

  • Placebo (NNC6019-0001)

    Drug

    Placebo matched to NNC6019-0001 will be administered IV.

Treatment groups

1,280 Participants
are divided into 2 treatment groups
Group A: NNC6019-0001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Measured as count of events.

Time frame
From baseline (week 0) to end of study (EOS) (up to approximately 4 years)

Secondary outcomes

1

Change in Kansas city cardiomyopathy questionnaire- clinical summary score (KCCQ-CSS)

Measured as score on a scale. KCCQ-CSS is a score derived from a 23-item patient-reported outcome (PRO) measure assessing health status in individuals with HF. The score ranges from 0 to 100, with higher scores indicating better health status.

Time frame
From baseline (week 0) to approximately 2 years
2

Change in Kansas city cardiomyopathy questionnaire- overall summary score (KCCQ-OSS)

Measured as score on a scale. KCCQ-OSS is a score derived from a 23-item PRO measure assessing health status in individuals with HF. The score ranges from 0 to 100, with higher scores indicating better health status.

Time frame
From baseline (week 0) to approximately 2 years
3

Change in 6-minute walk distance (6MWD)

Measured in meters.

Time frame
From baseline (week 0) to approximately 2 years
4

Number of occurrences of CV events (CV hospitalisation and urgent HF visits)

Measured as count of events.

Time frame
From baseline (week 0) to EOS (up to approximately 4 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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