NCT07023614 · Imbria Pharmaceuticals, Inc.
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
(FORTITUDE-HCM)
What this study is about
FORTITUDE-HCM is a global, conducted at multiple hospitals, where neither patients nor doctors know which treatment is given, parallel-group, compared against an inactive treatment Phase 2b study that will assess the effectiveness and safety of ninerafaxstat compared to placebo on top of the usual treatment in patients with symptomatic nHCM
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- La Jolla, California
- Los Angeles, California
- San Francisco, California
- Washington D.C., District of Columbia
- Miami, Florida
- Chicago, Illinois
- Oak Lawn, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Burlington, Massachusetts
- Grand Rapids, Michigan
- Rochester, Minnesota
And 9 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations