Obstructive Hypertrophic CardiomyopathyPhase 3NCT06116968
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
A Phase 3 study testing Aficamten in people with Obstructive Hypertrophic Cardiomyopathy, run by Corxel Pharmaceuticals at 12 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- Aficamten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 12 sitesChina
- Study dates
- 14 Nov 2023to 20 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of a Cytokinetics trial investigating CK-3773274
- LVEF ≥55% at the Screening Visit
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Anzhen Hospital
Beijing
Beijing Chao-yang Hospital, Capital Medical University
Beijing
Fuwai Hospital, CAMS & PUMC
Beijing
Peking University Third Hospital
Beijing
Sichuan Provincial People's Hospital
Chengdu
Nanfang Hospital
Guangzhou
The Second Affiliated Hospital of Nanchang University
Jiangxi
The First Hospital of Jilin University
Jilin City
Shengjing Hospital of China Medical University
Shenyang
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: An Open-Label Study of Aficamten for Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
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.
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Being tested
- Aficamten
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AficamtenDrug
Also called CK-3773274
5-20mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aficamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient incidence of reported adverse events (AEs)
Measured: Baseline to End of study, up to 2 years
Patient incidence of reported serious adverse events (SAEs )
Measured: Baseline to End of study, up to 2 years
Patient incidence of LVEF<50% & LVEF <40%
Measured: Baseline to End of study, up to 2 years
Secondary outcomes (11)
Peak LVOT-G at rest and with Valsalva provocation
Measured: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with resting LVOT-G <50 mmHg
Measured: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with resting LVOT-G <30 mmHg
Measured: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with post-Valsalva LVOT-G <50 mmHg
Measured: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with post-Valsalva LVOT-G <30 mmHg
Measured: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg
Measured: Change from baseline values to week 48 at 12-week intervals;
First resting LVOT-G <50 mmHg
Measured: Time to the following event through last follow-up, up to 2 years.
First resting LVOT-G <30 mmHg
Measured: Time to the following event through last follow-up, up to 2 years.
First post-Valsalva LVOT-G <50 mmHg
Measured: Time to the following event through last follow-up, up to 2 years.
First post-Valsalva LVOT-G <30 mmHg
Measured: Time to the following event through last follow-up, up to 2 years.
First LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg
Measured: Time to the following event through last follow-up, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start14 Nov 2023
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corxel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuhui Zhang, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116968
- Sponsor's protocol ID
- JX01003
- Other IDs
- CTR20233249
- Status last verified
- Jan 2026
- First submitted
- 25 Oct 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Aficamten for Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06116968
- Acronym / sponsor ID
- JX01003
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Corxel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aficamten | Experimental | Drug: AficamtenPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completion of a Cytokinetics trial investigating CK-3773274
- LVEF ≥55% at the Screening Visit
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AficamtenAlso: CK-37732745-20mg | Drug | Aficamten |
Primary outcome
Patient incidence of reported adverse events (AEs)
Time frame: Baseline to End of study, up to 2 years
Patient incidence of reported serious adverse events (SAEs )
Time frame: Baseline to End of study, up to 2 years
Patient incidence of LVEF<50% & LVEF <40%
Time frame: Baseline to End of study, up to 2 years
11 secondary outcomes
Peak LVOT-G at rest and with Valsalva provocation
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with resting LVOT-G <50 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with resting LVOT-G <30 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with post-Valsalva LVOT-G <50 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with post-Valsalva LVOT-G <30 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
Proportion of patients with LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg
Time frame: Change from baseline values to week 48 at 12-week intervals;
First resting LVOT-G <50 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.
First resting LVOT-G <30 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.
First post-Valsalva LVOT-G <50 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.
First post-Valsalva LVOT-G <30 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.
First LVEF ≥50%, resting LVOT-G <30 mmHg, and post-Valsalva LVOT-G <50 mmHg
Time frame: Time to the following event through last follow-up, up to 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuhui Zhang, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aficamten in people with Obstructive Hypertrophic Cardiomyopathy, run by Corxel Pharmaceuticals at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient incidence of reported adverse events (AEs) (time frame: Baseline to End of study, up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.