Heart failure & cardiomyopathies

Coramitug, a Humanized Monoclonal Antibody for the Treatment of Transthyretin Amyloid Cardiomyopathy: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

CirculationPublished Randomised controlled trial

Primary result · NT-proBNPResult — go to the resultEstimate −48% 95% CI −65% to −22%

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
Methodological detailsphase 2, double-blind, placebo-controlled, multicentre
  • Phase 2
  • Double-blind
  • Placebo-controlled
  • Multicentre

Primary result

NT-proBNP · baseline to week 52

Estimate

−48%

95% CI −65% to −22%

P = 0.0017

As reported in the abstract

Further findings

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

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