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

Imbria Pharmaceuticals

Status and phase

Not yet enrolling

Phase 2

Conditions

Non-obstructive Hypertrophic Cardiomyopathy

Treatments

Drug: Ninerafaxstat 200mg MR

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07023614

IMB101-010

Details and patient eligibility

About

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

Enrollment

165 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Select 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.