A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
A Global Phase 2b, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy - FORTITUDE-HCM
Imbria Pharmaceuticals, Inc.
165 participants
Oct 6, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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
Exclusion Criteria4
- 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
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Interventions
Ninerafaxstat 200mg Modified Release tablet administered BID
Matching placebo tablet administered BID
Locations(23)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07023614