Real-Life Clinical Efficacy of Acoramidis in Participants With ATTR-CM and Association With Cardiac Biomarkers

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT07306949
Phase
PHASE4
Status
Recruiting
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Conditions

  • Transthyretin-type Cardiac Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Acoramidis — DRUG
    Participants will receive acoramidis tablets orally.

Study Details

The purpose of this study is to confirm that the treatment with acoramidis prevents the deterioration of the ATTR-CM disease progression index and that these indexes are surrogate markers of disease progression.

Key Dates

Start date
Oct 1, 2025
Status verified
Jan 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acoramidis
    Participants will receive 800 mg of acoramidis twice daily for 18 months.

Primary Outcome Measure

Disease Progression Rate as Measured by N-terminal pro-brain-type Natriuretic Peptide (NT-proBNP) and/or Outpatient Diuretic Intensification (ODI) [ Time Frame: Baseline through 12 months ]

Central Contacts