A Phase 2 interventional study of I 124-Evuzamitide in Transthyretin Amyloidosis, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 50 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Columbia University · Phase 2, Interventional, and Diagnostic
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.
Transthyretin cardiac amyloidosis (ATTR-CA) causes progressive heart disease that is often overlooked. It harms the heart muscle because the unstable, unfurled amyloid proteins fold up into large pieces that get caught in between layers of heart tissue, causing amyloid deposits. The earlier it is detected, the better for the patient.
There is a need to improve the early diagnosis of this disease because echocardiography (sonograms of the heart) and cardiac MRI are not useful enough for this. There is an X-ray of the heart using a compound called PYP that can detect amyloid deposits earlier than ultrasound images or clinical signs, but it's not clear how early it does so. Also, it can't detect amyloid deposits outside the heart, which causes lots of pain and suffering in people with this disease.
In the first phase of this study the radiation compound, evuzamitide, was shown to detect amyloidosis in the heart of selected subjects. So, the investigators used it to detect potential therapeutic changes in 10 subjects undergoing treatment for Transthyretin Amyloidosis.
Changes in the uptake of evuzamitide were compared between subjects treated on stabilizer only, subjects treated on silencer only and subjects treated with two different combinations of stabilizer plus silencer
41 studies on the registry are indexed under Amyloidosis, Hereditary, Transthyretin-Related; 22 are open to participants now.
This study's enrollment of 10 is below the median of 157 across 20 interventional studies indexed under Amyloidosis, Hereditary, Transthyretin-Related.
Browse Amyloidosis, Hereditary, Transthyretin-Related studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Overall Inclusion Criteria:
The presence of any of the following excludes eligibility for enrollment in this study:
Subjects treated with tafamidis selected to re-scan to determine the change over time in Evuzamitide uptake
Drug: I 124-Evuzamitide
Subjects treated with vutrisiran selected to re-scan to determine the change over time in Evuzamitide uptake
Drug: I 124-Evuzamitide
Subjects treated with tafamidis and patisiran selected to re-scan to determine the change over time in Evuzamitide uptake
Drug: I 124-Evuzamitide
Subjects treated with vutrisiran and diflunisal selected to re-scan to determine the change over time in Evuzamitide uptake
Drug: I 124-Evuzamitide
Amyloid reactive protein used as imaging agent in whole body SPECT-CT imaging
Also known as: Attralus AT-01
Median of Uptake of Evuzamitide as Measured by Volume of Interest in Milliliters
Volumes of interest (VOIs) were manually traced on PET emission images fused with CT images to define the left ventricular (LV) and right ventricular (RV) contours, including cavity blood pool. Blood pool activity concentration was measured in a 10-mm-diameter left atrial spherical VOI. For 124I-evuzamitide, we used a threshold of mean + 2 standard deviations of blood pool activity concentration.
Time frame: Up to one month after imaging
Median of Change in Evuzamitide Uptake as Measured by Percentage Change in Injected Dose (%ID)
Median percentage change in injected dose (%ID), calculated as VOI mean activity concentration x VOI volume/injected activity.
Time frame: Up to one month after imaging
Median of Uptake of Evuzamitide as Measured by Cardiac Amyloid Activity (CAA) in Grams
Cardiac amyloid activity (CAA) in grams is measured as VOI mean standardized uptake value times VOI volume. Standardized uptake value was defined as mean or maximal VOI activity concentration/(injected activity/bodyweight), while target-to-background ratio was considered VOI mean activity concentration/blood pool mean activity concentration. VOI volume was manually traced on PET emission images fused with CT images.
Time frame: Up to one month after imaging
| Milestone | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) |
|---|---|---|---|---|
| Started | 4 | 1 | 3 | 2 |
| Completed | 4 | 1 | 2 | 2 |
| Not completed | 0 | 0 | 1 | 0 |
| Withdrew: Measurements were not usable due material error in imaging agent supplied | 0 | 0 | 1 | 0 |
Volumes of interest (VOIs) were manually traced on PET emission images fused with CT images to define the left ventricular (LV) and right ventricular (RV) contours, including cavity blood pool. Blood pool activity concentration was measured in a 10-mm-diameter left atrial spherical VOI. For 124I-evuzamitide, we used a threshold of mean + 2 standard deviations of blood pool activity concentration.
| mL | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) |
|---|---|---|---|---|
| Median of Uptake of Evuzamitide as Measured by Volume of Interest in Milliliters | 78.7 (13.4 to 137.8) | 253.6 (253.6 to 253.6) | 177.2 (-31.2 to 385.5) | 39.6 (1.4 to 77.8) |
Median percentage change in injected dose (%ID), calculated as VOI mean activity concentration x VOI volume/injected activity.
| percent change | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) |
|---|---|---|---|---|
| Median of Change in Evuzamitide Uptake as Measured by Percentage Change in Injected Dose (%ID) | 0.2 (-0.1 to 0.5) | 0.8 (0.8 to 0.8) | 1.3 (1.2 to 1.5) | 0.3 (0.2 to 0.4) |
Cardiac amyloid activity (CAA) in grams is measured as VOI mean standardized uptake value times VOI volume. Standardized uptake value was defined as mean or maximal VOI activity concentration/(injected activity/bodyweight), while target-to-background ratio was considered VOI mean activity concentration/blood pool mean activity concentration. VOI volume was manually traced on PET emission images fused with CT images.
| grams | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) |
|---|---|---|---|---|
| Median of Uptake of Evuzamitide as Measured by Cardiac Amyloid Activity (CAA) in Grams | 180.2 (-75.9 to 437.8) | 852.8 (852.8 to 852.8) | 952.5 (812.5 to 1092.5) | 155.4 (-18.7 to 329.4) |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stabilizer Only | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Silencer Only | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Stabilizer and Silencer (Tafamidis + Patisiran) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Stabilizer and Silencer (Vutrisiran + Diflunisal) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) |
|---|---|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 0/4 | 0/1 | 1/3 | 0/2 |
| Age, Continuous(years) | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) | Total |
|---|---|---|---|---|---|
| Mean | 68.75 (60 to 76) | 65 (65 to 65) | 75 (70 to 80) | 60 (53 to 67) | 67.77 (53 to 80) |
| Sex: Female, Male(Participants) | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 4 | 1 | 3 | 2 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 0 | 1 |
| Not Hispanic or Latino | 3 | 1 | 3 | 2 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 0 | 0 | 2 |
| White | 3 | 0 | 3 | 1 | 7 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| TTR Genotype(Participants) | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) | Total |
|---|---|---|---|---|---|
| Wild-Type | 2 | 0 | 3 | 0 | 5 |
| V122i | 2 | 0 | 0 | 0 | 2 |
| Val30Met | 0 | 0 | 0 | 1 | 1 |
| Thr60Ile | 0 | 1 | 0 | 0 | 1 |
| Asp38Glu | 0 | 0 | 0 | 1 | 1 |
| PYP Scan result(Participants) | Stabilizer Only | Silencer Only | Stabilizer and Silencer (Tafamidis + Patisiran) | Stabilizer and Silencer (Vutrisiran + Diflunisal) | Total |
|---|---|---|---|---|---|
| PYP Score 0 - no uptake | 0 | 0 | 0 | 0 | 0 |
| PYP Score 1 - less uptake than bone | 1 | 1 | 0 | 0 | 2 |
| PYP Score 2 - as much uptake as bone | 0 | 0 | 0 | 1 | 1 |
| PYP Score 3 - more uptake than bone | 3 | 0 | 2 | 1 | 6 |
| PYP Score 2 or 3 - indeterminate whether uptake is equal to or greater than bone | 0 | 0 | 1 | 0 | 1 |
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Amyloidosis, Hereditary, Transthyretin-Related→
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