NCT07207811

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

CLEOPATTRA: Effects of NNC6019-0001 Versus Placebo on Cardiovascular Outcomes in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,280 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	NNC6019-0001	NNC6019-0001 will be administered IV.
DRUG	Placebo (NNC6019-0001)	Placebo matched to NNC6019-0001 will be administered IV.

Timeline

• Start date: 2025-10-02
• Primary completion: 2029-06-29
• Completion: 2029-06-29
• First posted: 2025-10-06
• Last updated: 2026-03-19

Locations

285 sites across 20 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Ireland, Italy, Japan, Netherlands, Poland, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study