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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ninerafaxstat
  • Drug: Ninerafaxstat 200mg MR
    Ninerafaxstat 200mg Modified Release tablet administered BID
Placebo Comparator
Placebo
  • Drug: Placebo
    Matching placebo tablet administered BID

Recruiting Locations

Washington University in St. Louis and nearby locations

Imbria Investigational Site
St Louis 4407066, Missouri 4398678 63110
Contact:
Study Coordinator
314-362-1962
info@imbria.org

More Details

NCT ID
NCT07023614
Status
Recruiting
Sponsor
Imbria Pharmaceuticals, Inc.

Study Contact

Medical Monitor
(617) 675-4060
info@imbria.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.