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
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Imbria Investigational Site
RECRUITING
La Jolla
Imbria Investigational Site
RECRUITING
San Francisco
Washington, D.c.
Imbria Investigational Site
RECRUITING
Washington D.c.
Illinois
Imbria Investigational Site
RECRUITING
Chicago
Massachusetts
Imbria Investigational Site
RECRUITING
Boston
Imbria Investigational Site
RECRUITING
Burlington
Missouri
Imbria Investigational Site
RECRUITING
St Louis
Texas
Imbria Investigational Site
RECRUITING
Houston
Virginia
Imbria Investigational Site
RECRUITING
Charlottesville
Other Locations
France
Imbria Investigational Site
RECRUITING
Montpellier
Imbria Investigational Site
RECRUITING
Paris
Imbria Investigational Site
RECRUITING
Saint-herblain
Poland
Imbria Investigational Site
RECRUITING
Katowice
Portugal
Imbria Investigational Site
RECRUITING
Guimarães
Imbria Investigational Site
RECRUITING
Lisbon
Spain
Imbria Investigational Site
RECRUITING
A Coruña
Imbria Investigational Site
RECRUITING
Barcelona
Imbria Investigational Site
RECRUITING
Madrid
Imbria Investigational Site
RECRUITING
Seville
Imbria Investigational Site
RECRUITING
Seville
Imbria Investigational Site
RECRUITING
Vigo
United Kingdom
Imbria Investigational Site
RECRUITING
Glasgow
Imbria Investigational Site
RECRUITING
London
Contact Information
Primary
Medical Monitor
info@imbria.com
(617) 675-4060
Time Frame
Start Date: 2025-10-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 165
Treatments
Experimental: Ninerafaxstat
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Imbria Pharmaceuticals, Inc.