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Open-label extension study of long-term safety and efficacy of NNC6019-0001 in participants with transthyretin amyloid cardiomyopathy (ATTR CM)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502605-15-00
Acronym
NN6019-7565
Enrollment
58
Registered
2024-05-29
Start date
2024-09-16
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants with transthyretin amyloid cardiomyopathy (ATTR CM)

Brief summary

Number of treatment emergent adverse events from baseline (week 0) up to visit 39 (week 156)

Detailed description

Change in 6-minute walk test (6MWT) from baseline (week 0) to visit 28 (week 104), Change in NT-proBNP from baseline (week 0) to visit 28 (week 104), Change in myocardial extracellular volume from baseline (week 0) to visit 28 (week 104), Change in KCCQ-(CSS)2 from baseline (week 0) to visit 28 (week 104), Change in troponin I from baseline (week 0) to visit 28 (week 104), Change in GLS on echocardiography from baseline (week 0) to visit 28 (week 104)

Interventions

DRUGCETIRIZINE
DRUGPARACETAMOL
DRUGSODIUM CHLORIDE

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of treatment emergent adverse events from baseline (week 0) up to visit 39 (week 156)

Secondary

MeasureTime frame
Change in 6-minute walk test (6MWT) from baseline (week 0) to visit 28 (week 104), Change in NT-proBNP from baseline (week 0) to visit 28 (week 104), Change in myocardial extracellular volume from baseline (week 0) to visit 28 (week 104), Change in KCCQ-(CSS)2 from baseline (week 0) to visit 28 (week 104), Change in troponin I from baseline (week 0) to visit 28 (week 104), Change in GLS on echocardiography from baseline (week 0) to visit 28 (week 104)

Countries

Czechia, France, Germany, Italy, Netherlands, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026