Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM

Conditions

• Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Aficamten — DRUG
  Oral Tablet
• Placebo — DRUG
  Oral Tablet

Study Details

This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy.

Key Dates

Start date

Aug 30, 2023

Status verified

Jan 2026

Primary completion

Jun 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Aficamten
  Participants in this arm will receive a single daily oral dose of 5 mg, 10 mg, 15 mg, or 20 mg of aficamten with dose levels guided by echocardiography assessments, for up to 72 weeks.
• Placebo Comparator: Placebo
  Participants in this arm will receive placebo, for up to 72 weeks.

Primary Outcome Measure

Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) [ Time Frame: Baseline to Week 36 ]

Locations (60)

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