Obstructive Hypertrophic CardiomyopathyPhase 3CAMELLIA-HCMNCT07023341
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Phase 3 study testing BAY3723113 in people with Obstructive Hypertrophic Cardiomyopathy, run by Bayer at 23 sites in Japan.
Trial summary
Researchers are looking for a better way to treat Japanese people who have symptomatic obstructive hypertrophic cardiomyopathy (symptomatic oHCM). Obstructive hypertrophic cardiomyopathy (oHCM) is a type of heart disease where the heart muscles become thicker than normal due to over contraction. 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?
- BAY3723113
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 23 sitesJapan
- Study dates
- 30 Jun 2025to 30 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent.
- Diagnosed with HCM per the following criteria:
- Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease and
- Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory of:
- ≥15 mm in one or more myocardial segments OR
- ≥13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM
Show all 13Show fewer
- Has resting LVOT-G ≥ 30 mmHg and Valsalva LVOT-G =50 mmHg during screening as determined by the echocardiography core laboratory
- LVEF ≥ 60% at screening as determined by the echocardiography core laboratory
- NYHA Functional Class II or III at screening
- Hemoglobin ≥10 g/dL at screening
- Body mass index <35 kg/m²
- Japanese
- Patients on beta-blockers, verapamil, diltiazem, or disopyramide/cibenzoline should have been on a stable regimen for >6 weeks prior to the first dose of aficamten and anticipate remaining on the same medication regimen at least during the main study treatment period. Patients treated with disopyramide or cibenzoline must also be concomitantly treated with a beta blocker and/or calcium channel blocker.
Who cannot join
- Significant valvular heart disease (per investigator judgement)
- Moderate-severe valvular aortic stenosis and/or regurgitation
- Moderate-severe mitral regurgitation not due to systolic anterior motion of the mitral valve
- Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (e.g., Noonan syndrome, Fabry disease, amyloidosis)
- History of LV systolic dysfunction (LVEF <45%) or stress cardiomyopathy at any time during their clinical course
- Documented paroxysmal atrial fibrillation during the screening period
Show all 12Show fewer
- Paroxysmal or persistent/permanent atrial fibrillation is only excluded IF:
- Rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 6 months prior to screening
- Rate control and anticoagulation have not been achieved for at least 6 months prior to screening
- Has been treated with SRT (surgical myectomy or percutaneous alcohol septal ablation) or cannot postpone plans for SRT until after the study period
- History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
- Has received prior treatment with aficamten or mavacamten
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Japan23 sites
The University of Tokyo Hospital
Bunkyo, Tokyo, 113-8655
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8602
Sakakibara Heart Institute
Fuchū, Tokyo, 183-0003
Saiseikai Fukuoka General Hospital
Fukuoka, 810-0001
University of the Ryukyus Hospital
Ginowan, Okinawa, 901-2725
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Hyogo Prefectural HarimaHimeji General Medical Center
Himeji, Hyōgo, 670-8560
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Showa Medical University Koto Toyosu Hospital
Koto-ku, Tokyo, 135-8577
Kumamoto University Hospital
Kumamoto, 860-8556
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193
Kurume University Hospital
Kurume, Fukuoka, 830-0011
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Matsushita Memorial Hospital
Moriguchi, Osaka, 570-8540
Iwate Prefectural Central Hospital
Morioka, Iwate, 020-0066
Kochi Medical School Hospital
Nankoku, Kochi, 783-8505
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375
Tohoku University Hospital
Sendai, Miyagi, 980-8574
National Cerebral and Cardiovascular Center
Suita, Osaka, 564-8565
The University of Osaka Hospital
Suita, Osaka, 565-0871
Mie University Hospital
Tsu, Mie-ken, 514-8507
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
SHOWA Medical University Fujigaoka Hospital
Yokohama, Kanagawa, 227-8501
About this study
Official title: A Phase 3, Open Label, Single Arm Study to Evaluate Efficacy, Safety and Tolerability of Aficamten in Adult Japanese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Researchers are looking for a better way to treat Japanese people who have symptomatic obstructive hypertrophic cardiomyopathy (symptomatic oHCM).
Obstructive hypertrophic cardiomyopathy (oHCM) is a type of heart disease where the heart muscles become thicker than normal due to over contraction. This thickening makes it harder than normal due to over contraction. This thickening makes it harder for the heart to pump blood out to the rest of the body. In symptomatic oHCM people with the condition experience symptoms like shortness of breath, chest pain, fainting, high blood pressure and irregular heartbeats.
Read more
The study treatment aficamten, also called BAY3723113, is under development to treat symptomatic oHCM. It aims to reduce the activity of cardiac myosin, a protein that helps heart muscles to contract, and thereby preventing over contraction and muscle thickening.
Although treatment options are available for symptomatic oHCM, there is still need for other treatment options that help target the root cause of the condition. In this study, researchers want to understand about the effects and long-term safety of aficamten in Japanese people with symptomatic oHCM.
The main purpose of the study is to learn how well aficamten works in Japanese with symptomatic oCHM.
For this, the researchers will check how participant's heart blood flow changes after 6 months of treatment. They do this by measuring the pressure needed for blood to leave the heart using a test called the left ventricular outflow tract (LVOT) gradient and a special breathing technique called Valsava maneuver.
Researchers will also look for:
- the number of participants who will have at least 1 level improvement on a scale doctors use to assess the effect of heart problems on daily activities after 3 and 6 months of treatment
- the change in the impact of heart problems on participant's daily lives based on their feedback on a questionnaire called Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) after 3 and 6 months of treatment.
This study will have 2 treatment periods: main treatment period and long-term treatment period. During the main treatment period, participants will take aficamten tablets once daily by mouth for up to 6 months. After completing this period, the participants who can join the long-term treatment period will continue taking aficamten until the drug becomes commercially available in Japan or the study ends.
Each participant will be in the study as long as they benefit from the treatment.
Participants will visit the study site:
- once before the treatment starts
- 9 times with a gap of 2 to 4 weeks between the visits during treatment under the main treatment period, and in the long-term treatment period, participants will visit almost every 3 months until the treatment ends.
- then 2 more times with a gap of 1 month between the visits after the treatment ends.
During the study, the study doctors and their team will:
- check participant's health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) and echocardiogram (ECHO)
- ask the participants questions about how they are feeling and what adverse events are they having
An adverse event is any medical problem that a participant has during a study. Study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.
If the participant benefits from the treatment, treatment with aficamten after the end of the study might be possible.
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Being tested
- BAY3723113
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY3723113Drug
Also called CK-3773274
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Aficamten (BAY3723113) | Experimental | Aficamten will be administered orally once daily with or without food. Participants in this arm will receive a single daily oral dose of 5 mg, 10 mg, 15 mg, or 20 mg of Aficamten with dose levels guided by echocardiography assessments, for up to 24 weeks. Participants will receive a dose of Aficamten until the drug becomes commercially available in Japan or the study ends. Receives: Drug: BAY3723113 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Valsava LVOT-G
Measured: From baseline to Week 24
Secondary outcomes (9)
Change in resting LVOT-G
Measured: From baseline to Weeks 12 and 24
Change in Valsava LVOT-G
Measured: From baseline to Week 12
Change in N-terminal prohormone brain natriuretic peptide (NT-proBNP) value
Measured: From baseline to Week 24
Proportion of patricipants with ≥1 class improvement in New York Heart Association (NYHA) Functional Class
Measured: From baseline to Weeks 12 and 24
Change in KCCQ-CSS score
Measured: From baseline to weeks 12 and 24
Incidence of left ventricular ejection fraction (LVEF) <40%
Measured: From baseline to last follow up, up to 4 weeks
Incidence of LVEF <50%
Measured: From baseline to last follow up, up to 4 weeks
Incidence of treatment emergent adverse events (TEAE)
Measured: From baseline to last follow up, up to 4 weeks
Incidence of treatment emergent serious adverse events (TESAE)
Measured: From baseline to last follow up, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start30 Jun 2025
- Primary completion14 Jul 2026
- Study completion30 May 2028 (estimated)
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.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023341
- Sponsor's protocol ID
- 22976
- Acronym
- CAMELLIA-HCM
- Status last verified
- 1 Jun 2026
- First submitted
- 10 Jun 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open Label, Single Arm Study to Evaluate Efficacy, Safety and Tolerability of Aficamten in Adult Japanese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07023341
- Acronym / sponsor ID
- CAMELLIA-HCM / 22976
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 17 Jun 2025 (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.
Researchers are looking for a better way to treat Japanese people who have symptomatic obstructive hypertrophic cardiomyopathy (symptomatic oHCM).
Obstructive hypertrophic cardiomyopathy (oHCM) is a type of heart disease where the heart muscles become thicker than normal due to over contraction. This thickening makes it harder than normal due to over contraction. This thickening makes it harder for the heart to pump blood out to the rest of the body. In symptomatic oHCM people with the condition experience symptoms like shortness of breath, chest pain, fainting, high blood pressure and irregular heartbeats.
The study treatment aficamten, also called BAY3723113, is under development to treat symptomatic oHCM. It aims to reduce the activity of cardiac myosin, a protein that helps heart muscles to contract, and thereby preventing over contraction and muscle thickening.
Although treatment options are available for symptomatic oHCM, there is still need for other treatment options that help target the root cause of the condition. In this study, researchers want to understand about the effects and long-term safety of aficamten in Japanese people with symptomatic oHCM.
The main purpose of the study is to learn how well aficamten works in Japanese with symptomatic oCHM.
For this, the researchers will check how participant's heart blood flow changes after 6 months of treatment. They do this by measuring the pressure needed for blood to leave the heart using a test called the left ventricular outflow tract (LVOT) gradient and a special breathing technique called Valsava maneuver.
Researchers will also look for:
- the number of participants who will have at least 1 level improvement on a scale doctors use to assess the effect of heart problems on daily activities after 3 and 6 months of treatment
- the change in the impact of heart problems on participant's daily lives based on their feedback on a questionnaire called Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) after 3 and 6 months of treatment.
This study will have 2 treatment periods: main treatment period and long-term treatment period. During the main treatment period, participants will take aficamten tablets once daily by mouth for up to 6 months. After completing this period, the participants who can join the long-term treatment period will continue taking aficamten until the drug becomes commercially available in Japan or the study ends.
Each participant will be in the study as long as they benefit from the treatment.
Participants will visit the study site:
- once before the treatment starts
- 9 times with a gap of 2 to 4 weeks between the visits during treatment under the main treatment period, and in the long-term treatment period, participants will visit almost every 3 months until the treatment ends.
- then 2 more times with a gap of 1 month between the visits after the treatment ends.
During the study, the study doctors and their team will:
- check participant's health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) and echocardiogram (ECHO)
- ask the participants questions about how they are feeling and what adverse events are they having
An adverse event is any medical problem that a participant has during a study. Study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.
If the participant benefits from the treatment, treatment with aficamten after the end of the study might be possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aficamten (BAY3723113) | Experimental | Drug: BAY3723113Aficamten will be administered orally once daily with or without food. Participants in this arm will receive a single daily oral dose of 5 mg, 10 mg, 15 mg, or 20 mg of Aficamten with dose levels guided by echocardiography assessments, for up to 24 weeks. Participants will receive a dose of Aficamten until the drug becomes commercially available in Japan or the study ends. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent.
- Diagnosed with HCM per the following criteria:
- Has resting LVOT-G ≥ 30 mmHg and Valsalva LVOT-G =50 mmHg during screening as determined by the echocardiography core laboratory
- LVEF ≥ 60% at screening as determined by the echocardiography core laboratory
- NYHA Functional Class II or III at screening
Key exclusion criteria (12 listed)
- Significant valvular heart disease (per investigator judgement)
- Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (e.g., Noonan syndrome, Fabry disease, amyloidosis)
- History of LV systolic dysfunction (LVEF <45%) or stress cardiomyopathy at any time during their clinical course
- Documented paroxysmal atrial fibrillation during the screening period
- Paroxysmal or persistent/permanent atrial fibrillation is only excluded IF:
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 |
|---|---|---|
| BAY3723113Also: CK-3773274Oral tablet | Drug | Aficamten (BAY3723113) |
Primary outcome
Change in Valsava LVOT-G
Time frame: From baseline to Week 24
9 secondary outcomes
Change in resting LVOT-G
Time frame: From baseline to Weeks 12 and 24
Change in Valsava LVOT-G
Time frame: From baseline to Week 12
Change in N-terminal prohormone brain natriuretic peptide (NT-proBNP) value
Time frame: From baseline to Week 24
Proportion of patricipants with ≥1 class improvement in New York Heart Association (NYHA) Functional Class
Time frame: From baseline to Weeks 12 and 24
Change in KCCQ-CSS score
Time frame: From baseline to weeks 12 and 24
Incidence of left ventricular ejection fraction (LVEF) <40%
Time frame: From baseline to last follow up, up to 4 weeks
Incidence of LVEF <50%
Time frame: From baseline to last follow up, up to 4 weeks
Incidence of treatment emergent adverse events (TEAE)
Time frame: From baseline to last follow up, up to 4 weeks
Incidence of treatment emergent serious adverse events (TESAE)
Time frame: From baseline to last follow up, up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Related trials for Obstructive Hypertrophic Cardiomyopathy
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
RecruitingObservational study
Hypertrophic Cardiomyopathy Registry, Biobank and Imaging Data Repository
Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy
RecruitingPhase 3
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
Cardiomyopathy, Hypertrophic Obstructive
Active, not recruitingObservational study
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Not yet recruitingObservational study
Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy (oHCM)
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.
The record lists no contact. Use the official record to reach the sponsor.
23 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 BAY3723113 in people with Obstructive Hypertrophic Cardiomyopathy, run by Bayer at 23 sites in Japan.
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 13 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Valsava LVOT-G (time frame: From baseline to Week 24). 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 23 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.