A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy

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

  • Non-obstructive Hypertrophic Cardiomyopathy

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

Imbria Investigational Site
Washington D.C. 4140963, District of Columbia 4138106 20010
Contact:
Study Coordinator
202-877-6334

More Details

Status
Recruiting
Sponsor
Imbria Pharmaceuticals, Inc.

Study Contact

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