Heart failure & cardiomyopathiesRandomised controlled trial
Coramitug, a Humanized Monoclonal Antibody for the Treatment of Transthyretin Amyloid Cardiomyopathy: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial
- Randomised controlled trial
- phase 2
- double-blind
- placebo-controlled
- multicentre
Authors' conclusion
This phase 2 trial showed that coramitug, an antibody targeting misfolded transthyretin in transthyretin amyloidosis with cardiomyopathy, was well tolerated and, at a dose of 60 mg/kg, resulted in a statistically significant reduction in NT-proBNP, a validated marker of disease progression, with no statistically significant effect on 6-minute walk test within 52 weeks.
Study context
- Population
- Transthyretin amyloidosis with cardiomyopathyrandomized and dosed
- Participants
- 104 participants
- Comparison
- Coramitug vs placebo
- Coramitug 10 mg/kgn = 34
- Coramitug 60 mg/kgn = 35
- Placebon = 35reference
- Primary endpoint
- Change from baseline in 6-minute walk test and NT-proBNP
- Follow-up
- Week 52
Primary result
As reported in the abstract
baseline to week 52
Estimate
−48%
95% CI −65% to −22%
P = 0.0017
Further findings
Functional echocardiographic parameters
- Coramitug 60 mg/kg associated with improved functional echocardiographic parameters
Original publication
Coramitug, a Humanized Monoclonal Antibody for the Treatment of Transthyretin Amyloid Cardiomyopathy: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial. Circulation. Published 10 November 2025. doi:10.1161/circulationaha.125.077304
Summarised from the published abstract; every number is checked against it