NCT06116968

Brief Summary

This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

November 14, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

October 25, 2023

Last Update Submit

January 16, 2026

Conditions

Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

  • Patient incidence of reported adverse events (AEs)

    Baseline to End of study, up to 2 years

  • Patient incidence of reported serious adverse events (SAEs )

    Baseline to End of study, up to 2 years

  • Patient incidence of LVEF<50% & LVEF <40%

    Baseline to End of study, up to 2 years

Secondary Outcomes (11)

  • Peak LVOT-G at rest and with Valsalva provocation

    Change from baseline values to week 48 at 12-week intervals;

  • Proportion of patients with resting LVOT-G <50 mmHg

    Change from baseline values to week 48 at 12-week intervals;

  • Proportion of patients with resting LVOT-G <30 mmHg

    Change from baseline values to week 48 at 12-week intervals;

  • Proportion of patients with post-Valsalva LVOT-G <50 mmHg

    Change from baseline values to week 48 at 12-week intervals;

  • Proportion of patients with post-Valsalva LVOT-G <30 mmHg

    Change from baseline values to week 48 at 12-week intervals;

  • +6 more secondary outcomes

Study Arms (1)

Aficamten

EXPERIMENTAL

Patients in this arm take daily dose of Aficamten. Each patient will start at the lowest dose (5 mg) in the pre-specified dose range and undergo dose titration up to a maximum of 20 mg.

Drug: Aficamten

Interventions

AficamtenDRUG

5-20mg

Also known as: CK-3773274
Aficamten

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of a Cytokinetics trial investigating CK-3773274
  • LVEF ≥55% at the Screening Visit

You may not qualify if:

  • Has participated in another investigational device or drug study or received an investigational device or drug \<1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
  • Since completion of a previous study of aficamten has:Developed new-onset paroxysmal or permanent atrial fibrillation (AF) requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \<30 days prior to screening. Patient may rescreen for JX01003 after 30 days if heart rate (HR) \<100 bpm and/or rhythm is stable \>30 days.
  • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
  • Had a confirmed LVEF \<40% with an associated dose interruption during participation in a prior study with aficamten.
  • History of appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening.
  • Has received treatment with mavacamten.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Beijing Anzhen Hospital

Beijing, China

Location

Beijing Chao-yang Hospital, Capital Medical University

Beijing, China

Location

Fuwai Hospital, CAMS & PUMC

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Sichuan Provincial People's Hospital

Chengdu, China

Location

Nanfang Hospital

Guangzhou, China

Location

The Second Affiliated Hospital of Nanchang University

Jiangxi, China

Location

The First Hospital of Jilin University

Jilin, China

Location

Shengjing Hospital of China Medical University

Shenyang, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Yuhui Zhang, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 3, 2023

Study Start

November 14, 2023

Primary Completion

October 20, 2025

Study Completion

October 20, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(12)