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

Conditions

• Obstructive Hypertrophic Cardiomyopathy (oHCM)

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Aficamten (5 mg, 10 mg, 15 mg, and 20 mg) — DRUG
  Aficamten tablets were administered orally once daily.
• Placebo to match aficamten — DRUG
  Placebo tablets were administered orally once daily.

Study Details

The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) versus placebo in adults with symptomatic hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction.

Key Dates

Start date

Feb 1, 2022

Status verified

Feb 2025

Primary completion

Nov 10, 2023

Completion

Dec 18, 2023

Study Design

Enrollment

282 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Aficamten up to 20 mg
  Participants received 5 mg, 10 mg, 15 mg, or 20 mg of aficamten; dose levels were guided by echocardiography assessments. Treatment was administered for up to 24 weeks.
• Placebo Comparator: Placebo to match aficamten
  Participants received placebo for up to 24 weeks.

Primary Outcome Measure

Change From Baseline in pVO2 at Week 24 [ Time Frame: Baseline to Week 24 ]

Locations (48)

Related coverage on Hipa.ai

• Aficamten Phase 3 Trial Shows Significant oHCM Symptom and Exercise Improvement
  Aficamten · Mar 3, 2026 · ClinicalTrials.gov

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