Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

Completed · Phase 3 · Has a placebo group

Conditions studied: Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis, Cardiomyopathies, Heart Diseases

In brief

Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

Key facts

Study ID

NCT03860935

Run by

Eidos Therapeutics, a BridgeBio company

People needed

632

Starts

2019-03-19

Expected to finish

2023-05-11

Last updated by the study team

2024-06-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have an established diagnosis of ATTR-CM with either wild-type TTR or variant TTR genotype
• Have a history of heart failure evidenced by at least one prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated intracardiac pressures or heart failure symptoms that required or require ongoing treatment with a diuretic.
• New York Heart Association (NYHA) Class I-III symptoms due to ATTR cardiomyopathy.
• On stable doses of cardiovascular medical therapy
• Completed ≥150 m on the 6MWT on 2 tests that are within 15% of total distance walked prior to randomization
• Biomarkers of myocardial wall stress, NT-proBNP level ≥300 pg/mL at screening
• Have left ventricular wall (interventricular septum or left ventricular posterior wall) thickness ≥12 mm

You may not qualify if…

• Had acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening
• Has hemodynamic instability
• Likely to undergo heart transplantation within a year of screening
• Confirmed diagnosis of primary (light chain) amyloidosis
• Biomarkers of myocardial wall stress, NT-proBNP level ≥8500 pg/mL at screening
• Measure of kidney function, eGFR by MDRD formula <15 mL/min/1.73 m2
• Current treatment with marketed drug products and other investigational agents for the treatment of ATTR-CM
• Current treatment with calcium channel blockers with conduction system effects (e.g. verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digitalis will only be allowed if required for management of atrial fibrillation with rapid ventricular response

Where it is running

• Pacific Heart Institute — Santa Monica, California, United States
• University of Colorado Hospital - Anschutz Medical Campus — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Piedmont Heart Institute Athens — Athens, Georgia, United States
• Emory Heart and Vascular Center — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• MedStar Medical Group Cardiology at Franklin Square Medical Center — Baltimore, Maryland, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Saint Elizabeth's Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Luke's Hospital - Kansas City — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• North Shore University Hospital — Manhasset, New York, United States
• New York University Langone Health — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Laurelton Heart Specialist — Rosedale, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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