Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate 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 (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg) — DRUG
  Aficamten (CK-3773274) tablets administered orally
• Placebo to match aficamten — DRUG
  Placebo for aficamten (CK-3773274) administered orally
• Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg) — DRUG
  Metoprolol succinate tablets administered orally
• Placebo to match metoprolol succinate — DRUG
  Placebo for metoprolol succinate administered orally

Study Details

The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

Key Dates

Start date

Jun 20, 2023

Status verified

Apr 2025

Primary completion

Feb 28, 2025

Completion

Mar 28, 2025

Study Design

Enrollment

175 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Aficamten up to 20 mg plus placebo for metoprolol
  Patients will receive doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten (CK-3773274) plus placebo for metoprolol succinate with dose levels guided by echocardiography assessments for up to 24 weeks.
• Active Comparator: Metoprolol succinate up to 200 mg plus placebo for aficamten
  Patients will receive 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten (CK-3773274) with dose levels guided by echocardiography and heart rate assessments for up to 24 weeks.

Primary Outcome Measure

Change in peak oxygen uptake (pVO2) by cardiopulmonary exercise testing (CPET) [ Time Frame: Baseline to Week 24 ]

Locations (28)

Related coverage on Hipa.ai

• Aficamten Phase 3 Trial for oHCM Completes Primary Data Collection
  Aficamten · Feb 28, 2025 · ClinicalTrials.gov

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