NCT06081894

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

A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Aficamten	Oral Tablet
DRUG	Placebo	Oral Tablet

Timeline

• Start date: 2023-08-30
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2023-10-13
• Last updated: 2026-02-02

Locations

180 sites across 20 countries: United States, Argentina, Australia, Brazil, Canada, China, Denmark, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Japan, Netherlands, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study