Heart failure & cardiomyopathiesResearch article
Cliramitug for depletion of cardiac amyloid transthyretin: long-term follow-up of the NI006-101 trial
- Open-label extension of the NI006-101 first-in-human trial
- open-label extension (OLE2)
- long-term follow-up
- dose up-titration
Median of 10 additional infusions; maximum total exposure 24 infusions
Authors' conclusion
Consistent with results from the original trial, cliramitug showed favorable long-term safety and further reductions in cardiac amyloid burden following up-titration to 30 mg kg-1.
Study context
- Population
- Patients with ATTR-CM (all male; 20 on background tafamidis)all male
- Participants
- 23 patients
Main finding
As reported in the abstract
Long-term safety and efficacy · median follow-up 29.3 months
- Further reductions in cardiac extracellular volume on MRI and tracer uptake on bisphosphonate scintigraphy with continued treatment and up-titration
- Improvements in NT-proBNP, troponin T, LV relaxation, filling pressures and wall thickness
- Increases in Kansas City Cardiomyopathy Questionnaire scores (potential quality-of-life benefit)
Safety
Treatment-related serious AEs or discontinuations
- Treatment adherence
- 98%
- No treatment-related serious AEs or discontinuations
- open-label extension (OLE2)
Original publication
Cliramitug for depletion of cardiac amyloid transthyretin: long-term follow-up of the NI006-101 trial. Nat Med. Published 26 June 2026. doi:10.1038/s41591-026-04487-3
Summarised from the published abstract; every number is checked against it