Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy (NCT07675668) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy
56 participantsStarted 2026-10-01
Plain-language summary
The goal of this clinical trial is designed to characterise the safety, tolerability, efficacy, and PK of Aom0304 across oHCM and nHCM populations and to inform dose selection for future Phase 3 development. The main questions it aims to answer are:
1. Which dose is safe and tolerant of Aom0304 in participants with HCM?
2. Which dose is effective of 12 weeks of Aom0304 treatment in participants with oHCM or nHCM? Researchers will compare different doses of Aom0304 to see which works best. All participants will receive Aom0304, but at different dose levels depending on which cohort they joined.
Participants will:
1. Undergo screening up to 28 days before enrollment to confirm eligibility
2. Adjust dose every 2 weeks assessed by the Investigator according to predefined criteria at Titration Phase (Week 1 Day 1 to Week 8).
3. Continuation of the last tolerated and effective dose; no further escalation is permitted at Maintenance Phase (Week 8 to Week 12).
4. Study drug discontinued and follow up at Off-treatment Follow-up Period (at the end of Week 12 to Week 16).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to federal, local, and institutional guidelines before the first study-specific procedure.
. Men or women participants aged 18 to 70 years (both inclusive) at Screening.
. Documented diagnosed with HCM based on European Society of Cardiology/American College of Cardiology Foundation criteria: hypertrophied and non-dilated left ventricle in absence of other systemic or cardiac causes, with left ventricular wall thickness ≥ 15 mm at diagnosis or ≥ 13 mm with a positive family history of HCM, or a known gene mutation related to HCM.
. Participants who are already treated with β-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for at least 4 weeks prior to Day 1 and anticipate remaining on the same medication regimen during the study.
. Body weight must be ≥ 45 kg and body mass index 18 to 35 kg/m2 (both inclusive) at Screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability of Aom0304 in participants with HCM
. Symptomatic HCM defined as NYHA functional Class II or III at Screening.
. Part-specific requirements at Screening:
Exclusion criteria
. Participants with clinically significant haematology or chemistry abnormalities at Screening, as determined by the Investigator, including but not limited to:
. Known hypersensitivity to Aom0304, or any of the components of the formulation of Aom0304, or alcohol.
. History of sustained ventricular tachyarrhythmia or cardiac arrest.
. Implanted cardioverter defibrillator (ICD) placement within 3 months prior to Screening or planned ICD placement during the study.
. History of myocardial diseases other than HCM, including but not limited to: myocarditis, ischemic cardiomyopathy, dilated cardiomyopathy, cardiac amyloidosis, restrictive cardiomyopathy, Takotsubo syndrome, arrhythmogenic right ventricular cardiomyopathy.
. Poor controlled hypertension, defined as systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg at Screening or Baseline despite stable antihypertensive therapy.
. Participants who have been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or have plans for either treatment during the study period.
. History of syncope with exercise within past 6 months prior to Screening.