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Clinical Trials in the EU / 2024-515125-28-00
Authorised, recruiting Phase II

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

2024-515125-28-00 · tracked via the Priya Life Science EU tracker
Sponsor
Imbria Pharmaceuticals Inc
Sponsor type
Pharmaceutical company
Therapeutic area
Cardiovascular Diseases
Decision date
20/11/2025
Enrollment target
130
Sites
Austria, Germany, Belgium, France, Portugal, Spain, Netherlands, Italy, Poland

Condition studied

Non-obstructive hypertrophic cardiomyopathy

Investigational medicinal product(s)

Tabletidentical in appearance to ninerafaxstat tabletsNinerafaxstat

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-515125-28-00 on CTIS ↗ ← All trials in the EU