Transthyretin Amyloid Cardiomyopathy (ATTR CM) / NNC6019-0001 / Placebo (NNC6019-0001) · Phase 3 Trial

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

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

CLEOPATTRA is a Phase 3 randomized controlled trial of NNC6019-0001 (coramitug) versus placebo in patients with transthyretin amyloid cardiomyopathy, designed to assess reduction in cardiovascular death and recurrent cardiovascular events. This is a registry record only; no efficacy, safety, or outcome data have been reported, and the trial is currently recruiting.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Transthyretin Amyloid Cardiomyopathy (ATTR CM); age from 18 Years. Intervention: NNC6019-0001. Compared with: Placebo — Placebo Comparator. n = 1,280. 295 sites across 20 countries.

Key findings

Safety

This is a registry record with no results reported; no efficacy, safety, or outcome data are available. No interim efficacy, safety, or efficacy-stopping data are provided.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing a planned Phase 3 study with no results reported; the trial is actively recruiting and no efficacy or safety data are available.

Study design

As stated by the source record.

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

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationTransthyretin Amyloid Cardiomyopathy (ATTR CM); age from 18 Years

Sample size1,280

InterventionNNC6019-0001

ComparatorPlacebo — Placebo Comparator

Setting295 sites across 20 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment1280

PhasePhase 3

Primary outcomeComposite of cardiovascular deaths and recurrent cardiovascular events (hospitalizations and urgent heart failure visits) from baseline to end of study (up to approximately 4 years)

Study statusRECRUITING

Caveats

This is a registry record with no results reported; no efficacy, safety, or outcome data are available.
Recruitment is ongoing; study conduct and findings are not yet verifiable.
No interim efficacy, safety, or efficacy-stopping data are provided.
Generalizability and real-world applicability cannot be assessed until results are published.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized, placebo-controlled Phase 3 design for a hard endpoint.

Directness

strong

Primary outcome is composite of cardiovascular deaths and recurrent CV events.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Recruitment ongoing; blinding, allocation concealment, and conduct not yet verifiable.

Sample adequacy

strong

Planned enrollment of 1280 participants is adequate for primary outcome.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07207811). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1280 participants (ESTIMATED). Conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM). Interventions: DRUG: NNC6019-0001; DRUG: Placebo (NNC6019-0001). Primary outcome 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). Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Novo NordiskTransthyretin Amyloid Cardiomyopathy (ATTR CM)NNC6019-0001NCT07207811Placebo (NNC6019-0001)