NCT07023614RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- First submitted
- 9 Jun 2025
- Start date
- Oct 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Imbria Pharmaceuticals, Inc.
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07023614
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 165
- From Oct 2025 to the primary completion date, Dec 2026
- 60 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (60)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.