NCT07023614 A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
| NCT ID | NCT07023614 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Imbria Pharmaceuticals, Inc. |
| Condition | Non-obstructive Hypertrophic Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 165 participants in total. It began in 2025-10-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with symptomatic nHCM
Eligibility Criteria
Select Inclusion Criteria: * Has a clinical diagnosis of HCM consistent with current American College of Cardiology/American Heart Association and European Society of Cardiology Guideline definitions * Has had confirmation of nHCM by the echocardiography core laboratory based on screening rest and exercise stress echocardiography * New York Heart Association (NYHA) functional Class II or III at screening * Functional limitation as defined by a screening CPET Select Exclusion Criteria: * Has a known or suspected infiltrative, genetic, or storage disorder causing cardiac hypertrophy that mimics nHCM * Has any other condition judged by the investigator to be the primary cause of dyspnea, exercise intolerance, and/or angina * Has an inability to exercise on a treadmill or bicycle (eg, orthopedic limitations) * Has any medical condition that precludes upright exercise stress testing Other protocol-defined inclusion and exclusion criteria apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07023614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-obstructive Hypertrophic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07023614 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07023614 currently recruiting?
Yes, NCT07023614 is actively recruiting participants. Contact the research team at info@imbria.com for enrollment information.
Where is the NCT07023614 trial being conducted?
This trial is being conducted at La Jolla, United States, Los Angeles, United States, San Francisco, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT07023614 clinical trial?
NCT07023614 is sponsored by Imbria Pharmaceuticals, Inc.. The trial plans to enroll 165 participants.