Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

• Status: Active, not recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eidos Therapeutics; Eidos Therapeutics, a BridgeBio company

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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