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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515125-28-00

Acronym

IMB101-010

Enrollment

130

Registered

2025-11-20

Start date

2025-12-08

Completion date

Unknown

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-obstructive hypertrophic cardiomyopathy

Brief summary

Change from baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).

Detailed description

1. Change in ventilatory efficiency (VE/VCO2 slope) during CPET from baseline to Week 12, 2. Change from baseline to Week 12 in the KCCQ-TSS, 3. Change from baseline to Week 12 in the KCCQ-PLS, 4. Change from baseline to Week 12 in the KCCQ-OSS, 5. Change in exercise duration during CPET from baseline to Week 12

Interventions

DRUGTablet

DRUGidentical in appearance to ninerafaxstat tablets

DRUGNinerafaxstat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).	—

Secondary

Measure	Time frame
1. Change in ventilatory efficiency (VE/VCO2 slope) during CPET from baseline to Week 12, 2. Change from baseline to Week 12 in the KCCQ-TSS, 3. Change from baseline to Week 12 in the KCCQ-PLS, 4. Change from baseline to Week 12 in the KCCQ-OSS, 5. Change in exercise duration during CPET from baseline to Week 12	—

Countries

Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026