ATTRibute-CM Is a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Cardiomyopathy

About the Attribute-cm global PHASE 3 trial

An ongoing Phase 3 trial of AG10 in patients with symptomatic ATTR cardiomyopathy (ATTR-CM) is now enrolling (ClinicalTrials.gov Identifier: NCT03860935).

trial design trial design

1

  • Eligible patients will be randomized in a 2:1 ratio and receive either AG10 800 mg or matching placebo orally, twice daily
  • Screening and randomization will be followed by a total of 30 months of blinded, placebo-controlled treatment

2

  • At the end of 12 months of treatment (Part A), efficacy of AG10 will be assessed through analysis of the functional Six-Minute Walk Test (6MWT) and health-related quality of life (QoL) (as measured by the heart failure (HF)-specific instrument Kansas City Cardiomyopathy Questionnaire [KCCQ]) endpoints
  • At the end of 30 months of treatment (Part B), efficacy of AG10 will be further assessed through analysis of all-cause mortality and cardiovascular (CV)-related hospitalization. NOTE: During Part B, as local standard of care evolves, concomitant use of approved, indicated therapies may be allowed

3

  • All subjects who complete 30 months of blinded trial therapy and the final assessments of the double-blind treatment period may be eligible to participate in an open-label extension trial of long-term AG10 treatment

Eligibility Criteria

Key Inclusion Criteria*:

  • Male or female between the ages of ≥18 and ≤90 (inclusive)
  • Established diagnosis of ATTR-CM with either wild-type transthyretin (TTR) or variant TTR genotype
  • History of heart failure evidenced by one of the following:
    • at least one prior hospitalization for heart failure clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload
    • elevated intracardiac pressures
    • heart failure symptoms that required or require ongoing treatment with a diuretic
  • New York Heart Association (NYHA) Class I-III symptoms due to ATTR-CM
  • Completed ≥150 m on the 6MWT on two consecutive tests prior to randomization

Key Exclusion Criteria*:

  • Acute myocardial infarction, acute coronary syndrome, coronary revascularization, or stroke within 90 days prior to screening
  • Likely to undergo heart transplantation within a year of screening
  • Confirmed diagnosis of primary (light-chain) amyloidosis
  • Current treatment with marketed drug products and other investigational agents for the treatment of ATTR-CM

* Additional inclusion and exclusion criteria apply. Patients must meet all eligibility criteria to be considered for the clinical research trial. For more information, search NCT03860935 on ClinicalTrials.gov.

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