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
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT07207811
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- NNC6019-0001 — DRUGNNC6019-0001 will be administered IV.
- Placebo (NNC6019-0001) — DRUGPlacebo matched to NNC6019-0001 will be administered IV.
Study Details
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.
Key Dates
- Start date
- Oct 2, 2025
- Status verified
- May 2026
- Primary completion
- Jun 29, 2029
- Completion
- Jun 29, 2029
Study Design
- Enrollment
- 1,280 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: NNC6019-0001Participants will receive NNC6019-0001 intravenously (IV). Participants will also have the option to continue any Standard of care (SoC) treatments as recommended by their medical health professional.
- Placebo Comparator: PlaceboParticipants will receive placebo matched to NNC6019-0001 IV. Participants will also have the option to continue any SoC treatments as recommended by their medical health professional.
Primary Outcome Measure
Composite Outcome of cardiovascular (CV) deaths and recurrent CV events (CV hospitalisations and urgent heart failure [HF] visits) [ Time Frame: From baseline (week 0) to end of study (EOS) (up to approximately 4 years) ]
Central Contacts
- Novo Nordisk(+1) 866-867-7178