Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

Conditions

• Amyloid Cardiomyopathy
• Amyloidosis
• Cardiomyopathies
• Heart Diseases
• Transthyretin Amyloidosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• acoramidis — DRUG
  TTR stabilizer administered orally twice daily (BID)
• Placebo Oral Tablet — DRUG
  Non-active control administered orally twice daily (BID)

Study Details

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 Dates

Start date

Mar 19, 2019

Status verified

Jun 2024

Primary completion

May 11, 2023

Completion

May 11, 2023

Study Design

Enrollment

632 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: acoramidis HCl 800 mg
  Subjects will receive acoramidis HCl 800 mg twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.
• Placebo Comparator: Placebo
  Subjects will receive placebo to match twice daily. 6MWT primary outcome will be assessed at the end of 12 months. The hierarchical combination of All-Cause mortality, cumulative frequency of cardiovascular-related hospitalizations, change from baseline in NT-proBNP levels, and change from baseline in distance walked on the 6MWT will be assessed after 30 months of treatment.

Primary Outcome Measure

A Hierarchical Combination of All-Cause Mortality, Cumulative Frequency of CV-related Hospitalization, Change From Baseline in NT-proBNP and Change From Baseline in 6MWT at the Last Available Visit Where Both Subjects Had Non-missing Assessments. [ Time Frame: Baseline up to Month 30 ]

Locations (40)

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