This study is testing a new radiotracer dye called I-124 evuzamitide in patients with suspected cardiac amyloidosis. Cardiac amyloidosis occurs when proteins misfold and deposit as amyloid fibrils in the heart. The build up of these fibrils (proteins) cause the heart to enlarge due to wall thickening so the heart has to work harder. Over time, this can lead to heart failure. I-124 evuzamitide is given during a Positron Emissions Tomography/ Computed Tomography (PET/CT) scan to help diagnose cardiac amyloidosis. It is not a treatment for amyloidosis. I-124 evuzamitide is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration. (FDA). It will be given one time through an intravenous line, meaning in the vein before the PET/CT scan.

This study will last about 60 days and include 4 visits. The final study visit will take place at day 30 but medical records will be reviewed up to day 60. In addition to receiving I-124 evuzamitide, participants will also receive potassium iodide, an approved medication, by mouth to take for 3 days to protect the thyroid gland from the radiotracer I-124 evuzamitide, electrocardiogram (ECG), bloodwork and questionnaires.

The purpose of this study is to evaluate the safety and effectiveness of acoramidis (AG-10) and determine if it can help people with the genetic TTR variant that can cause ATTR-CM. The sponsor (Eidos) is conducting a research study to see if the study medicine will help in slowing the development and/or progression of a rare disease called Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM). AG-10 is an investigational drug. "Investigational" means that AG-10 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. Cardiomyopathy is a disease of the heart muscle that makes it harder for the heart to pump blood to the rest of the body. AG-10 has been shown to reduce the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time.

If you meet the requirements and agree to participate in this study, you will go through a 2 part screening period and if approved you will begin treatment. You will be randomized, like flipping a coin, to drug or placebo and take two pills once every day for 60 months.
Your participation in this study will last up to 60 month and will consist of clinic visits and follow up visits at home via the telephone. Some tests requires of you will include an echo, ECG, cardioradionuclide scans (scans that use radioactive agents to look at images of the heart like a PET scan), MRIs, blood tests, nerve conduction test, urine samples, and skin biopsies.