The Phase 3 open-label study (NCT06116968) investigating Aficamten for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in Chinese patients completed on 2025-10-20. This study enrolled 40 participants and focused on collecting long-term safety and tolerability data.
Background
Aficamten is being investigated for the treatment of obstructive hypertrophic cardiomyopathy (oHCM). This condition is characterized by thickening of the heart muscle, which can impede blood flow.
Trial design
The study, identified as NCT06116968, is a Phase 3, open-label extension study. It enrolled 40 Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The primary objective of this study was to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state pharmacokinetics during chronic dosing with Aficamten.
What this means
The completion of this Phase 3 open-label study marks a step forward in gathering comprehensive long-term safety and tolerability data for Aficamten in Chinese patients with oHCM. The data collected on cardiac function and pharmacokinetics will be crucial for understanding the drug's profile in this specific population.
Source
The information regarding the completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06116968, titled "An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM," was posted on 2025-10-20 on clinicaltrials.gov.