A Phase 2 interventional study of Ninerafaxstat 200mg MR and Placebo in Non-obstructive Hypertrophic Cardiomyopathy, sponsored by Imbria Pharmaceuticals, Inc.. Recruiting at 67 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Imbria Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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
347 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 110 are open to participants now.
This study's planned enrollment of 165 is above the median of 59 across 171 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →Imbria Pharmaceuticals, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Drug: Ninerafaxstat 200mg MR
Drug: Placebo
Ninerafaxstat 200mg Modified Release tablet administered BID
Matching placebo tablet administered BID
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
The Clinical Summary Score is a merging of symptom frequency and symptom burden domains into a total symptom score combined with the physical limitation domain. Scoring ranges from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline to Week 12
Change in ventilatory efficiency (VE/VCO2 slope) during cardiopulmonary exercise testing (CPET)
Time frame: Baseline to Week 12
Change in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)
The Total Symptom Score is a merging of symptom frequency and symptom burden domains. Scoring ranges from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline to Week 12
Change in the Kansas City Cardiomyopathy Questionnaire Physical Limitations Score (KCCQ-PLS)
The Physical Limitations Score is a single-domain score. Scoring ranges from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline to Week 12
Change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS)
The Overall Summary Score is a merging of symptom, physical limitations, social limitations, and quality of life domains. Scoring ranges from 0 to 100, with higher scores indicating better health status.
Time frame: Baseline to Week 12
Plan to share: Undecided
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Imbria Pharmaceuticals, Inc.