Study Comparing Coramitug NNC6019-0001 Versus Placebo in Adults with Heart Failure Caused by Transthyretin Amyloid Cardiomyopathy

What this Trial Is About

Researchers are evaluating a new medicine called NNC6019-0001 for people with transthyretin amyloid cardiomyopathy ATTR-CM, a condition that affects the heart and leads to heart failure. This Phase 3 study compares NNC6019-0001 with a placebo to see if it can reduce the risk of heart-related death and illness. Participants will continue their usual heart treatments throughout the study. Participants will receive either NNC6019-0001 or a matching placebo through intravenous IV infusion. Both groups may also continue their standard heart failure treatments as advised by their doctors. The study is randomized and blinded so that neither participants nor researchers know who receives the medicine or placebo. Treatment and follow-up will last up to about 4 years. During the study, participants will have regular assessments including heart function tests, questionnaires about heart failure symptoms and quality of life, and walking tests to measure physical ability. Researchers will monitor heart-related events such as hospitalizations and urgent visits for heart failure, as well as death from cardiovascular causes. Safety labs and biomarker tests will be done. The main outcome is a combination of cardiovascular deaths and recurrent heart problems measured from the start to the end of the study.

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