AG10-304

Condition: Symptomatic transthyretin amyloid cardiomyopathy

Eligibility

Key Inclusion Criteria:

  • Completed 30 months of the study treatment in Study AG10-301 and the Study AG10-301, Month 30 visit
  • Must agree to use a highly effective method of contraception beginning with enrollment and continuing for 30 days after the last dose of acoramidis

Key Exclusion Criteria:

  • Acute myocardial infarction, acute coronary syndrome or coronary revascularization within 90 days prior to Day 1 stroke or transient ischemic attack within 90 days prior to Day 1
  • Hemodynamic instability (abnormal or unstable blood pressure) that would pose too great a risk for participation in the study
Study Name

An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants With Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase III Attribute-CM Trial (AG10-304) (IRB no. 00001728)

Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called acoramidis (AG10) for the treatment of a rare disease called symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM). ATTR-CM occurs when a protein in the blood, called transthyretin, clumps together in the blood and accumulates in the heart. This accumulation in the heart is called amyloidosis. Acoramidis binds to transthyretin and by making transthyretin stable, acoramidis may slow the accumulation in the heart. All participants will receive acoramidis by taking 2 pills twice a day.

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