Phase 2
N=10
Evuzamitide in PET/CT to Measure Potential Therapeutic Response in ATTR
Transthyretin Amyloidosis
Bottom Line
View on ClinicalTrials.gov: NCT05635045 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Median of Uptake of Evuzamitide as Measured by Volume of Interest in Milliliters — 78.7; 253.6; 177.2; 39.6 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- I 124-Evuzamitide (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median of Uptake of Evuzamitide as Measured by Volume of Interest in Milliliters |
78.7; 253.6; 177.2; 39.6 | — |
| PRIMARY Median of Change in Evuzamitide Uptake as Measured by Percentage Change in Injected Dose (%ID) |
0.2; 0.8; 1.3; 0.3 | — |
| PRIMARY Median of Uptake of Evuzamitide as Measured by Cardiac Amyloid Activity (CAA) in Grams |
180.2; 852.8; 952.5; 155.4 | — |
Summary
This was a single center, prospective cohort study that is evaluating the ability of 124I-evuzamitide PET scanning to detect potential therapeutic changes in subjects under treatment for ATTR after one year had elapsed since their original 124I-evuzamitide PET scan.
Ten previously scanned subjects re-consented to undergo another 124I-evuzamitide PET scan. Demographic, clinical and phenotypic data were collected to characterize potential changes since their previous scans.
Eligibility Criteria
Inclusion Criteria
- Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
- Were enrolled in the initial pilot using 124I-Evuzamitide, on ATTR stabilizer and/or silencer therapy. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
- TTR genotype shown to be either Val122Ile or wild type.
Exclusion Criteria
Overall Inclusion Criteria:
- Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
- Were enrolled in the initial pilot using 124I-Evuzamitide, on ATTR stabilizer and/or silencer therapy. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
- TTR genotype shown to be either Val122Ile or wild type.
The presence of any of the following excludes eligibility for enrollment in this study:
- Primary amyloidosis (AL) or secondary amyloidosis (AA).
- Active malignancy or non-amyloid disease with expected survival of less than 1 year.
- Heart failure, in the opinion of the investigator, primarily caused by something other than amyloidosis.
- Ventricular assist device.
- Impairment from stroke, injury or other medical disorder that precludes participation in the study.
- Disabling dementia or other mental or behavioral disease.
- Enrollment in a clinical trial not approved for co-enrollment.
- Continuous intravenous inotropic therapy.
- Inability or unwillingness to comply with the study requirements.
- Chronic kidney disease requiring hemodialysis or peritoneal dialysis.
- Patients taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation.
- Other reason that would make the subject inappropriate for entry into this study.
Data sourced from ClinicalTrials.gov (NCT05635045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.