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A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Sponsor: Imbria Pharmaceuticals, Inc.
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
165
Start Date
2025-10-06
Completion Date
2026-12
Last Updated
2026-02-09
Healthy Volunteers
No
Interventions
Ninerafaxstat 200mg MR
Ninerafaxstat 200mg Modified Release tablet administered BID
Placebo
Matching placebo tablet administered BID
Locations (23)
Imbria Investigational Site
La Jolla, California, United States
Imbria Investigational Site
San Francisco, California, United States
Imbria Investigational Site
Washington D.C., District of Columbia, United States
Imbria Investigational Site
Chicago, Illinois, United States
Imbria Investigational Site
Boston, Massachusetts, United States
Imbria Investigational Site
Burlington, Massachusetts, United States
Imbria Investigational Site
St Louis, Missouri, United States
Imbria Investigational Site
Houston, Texas, United States
Imbria Investigational Site
Charlottesville, Virginia, United States
Imbria Investigational Site
Montpellier, France
Imbria Investigational Site
Paris, France
Imbria Investigational Site
Saint-Herblain, France
Imbria Investigational Site
Katowice, Poland
Imbria Investigational Site
Guimarães, Portugal
Imbria Investigational Site
Lisbon, Portugal
Imbria Investigational Site
Barcelona, Barcelona, Spain
Imbria Investigational Site
A Coruña, Galicia, Spain
Imbria Investigational Site
Madrid, Madrid, Spain
Imbria Investigational Site
Vigo, Pontevedra, Spain
Imbria Investigational Site
Seville, Sevilla, Spain
Imbria Investigational Site
Seville, Sevilla, Spain
Imbria Investigational Site
London, England, United Kingdom
Imbria Investigational Site
Glasgow, Scotland, United Kingdom