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
NCT07207811 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1280
Last updated 2026-04-27
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.
Conditions
- Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Interventions
- DRUG
-
NNC6019-0001
NNC6019-0001 will be administered IV.
- DRUG
-
Placebo (NNC6019-0001)
Placebo matched to NNC6019-0001 will be administered IV.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency (dept. 2834) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-02
- Primary Completion
- 2029-06-29
- Completion
- 2029-06-29
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- China
- Czechia
- Denmark
- France
- Germany
- Ireland
- Italy
- Japan
- Netherlands
- Poland
- South Korea
- Spain
- Sweden
- United Kingdom
Study Locations
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