At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ninerafaxstat 200mg MR (drug), Placebo (drug)
- How long the study runs
- Study runs about 14 months (dates as stated)
- About the drug or intervention
- Ninerafaxstat 200mg MR — drug: Ninerafaxstat 200mg Modified Release tablet administered BID · Placebo — drug: Matching placebo tablet administered BID
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial, run by Imbria Pharmaceuticals, Inc., is testing a medicine called ninerafaxstat. It is for people with symptomatic non-obstructive hypertrophic cardiomyopathy (a heart condition where the heart muscle is thickened but blood flow is not blocked). The study aims to find out how well the medicine works and how safe it is.
Who can take part
- You have a diagnosis of hypertrophic cardiomyopathy based on current US and European heart guidelines.
- Tests, including an ultrasound of the heart at rest and during exercise, confirm you have the non-obstructive type of the condition.
- You have symptoms such as breathlessness that put you in New York Heart Association Class II or III at screening (this means your daily activities are somewhat or clearly limited).
- A screening exercise test (called CPET) shows you have a functional limitation (trouble with physical activity).
Who may not be able to
- You have another condition, such as an infiltrative, genetic, or storage disorder, that causes heart thickening which mimics this condition.
- The study doctor thinks another condition is the main cause of your breathlessness, exercise problems, or chest pain.
- You cannot exercise on a treadmill or bicycle, for example because of bone or joint problems.
- You have a medical condition that means you cannot do upright exercise stress tests.
- Other inclusion and exclusion rules in the study protocol also apply.
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 165
- Started
- 2025-10-06
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for non-obstructive hypertrophic cardiomyopathy
- • Phase2 - 165 participants
- • 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 take part?
- • Ages 18 Years and over
- • Diagnosed with non-obstructive hypertrophic cardiomyopathy
Where?
- • London - Imbria Investigational Site
- • Glasgow - Imbria Investigational Site
- • London - Imbria Investigational Site
- • London - Imbria Investigational Site
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Has a clinical diagnosis of HCM consistent with current American College of Cardiology/American Heart Association...
- ✓Has had confirmation of nHCM by the echocardiography core laboratory based on screening rest and exercise stress...
- ✓New York Heart Association (NYHA) functional Class II or III at screening
- ✓Functional limitation as defined by a screening CPET
- ✓Select
Who cannot take part
- ✗Has a known or suspected infiltrative, genetic, or storage disorder causing heart hypertrophy that mimics nHCM
- ✗Has any other condition judged by the investigator to be the primary cause of dyspnea, exercise intolerance, and/or...
- ✗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.
See the full criteria
Where Is This Study? (5 UK sites)
Imbria Investigational Site
London W12 0HS, United Kingdom
Imbria Investigational Site
Glasgow G51 4TF, United Kingdom
Imbria Investigational Site
London EC1A 7BE, United Kingdom
Imbria Investigational Site
London SW3 6HP, United Kingdom
Imbria Investigational Site
Oxford OX3 9DU, United Kingdom
How to Get in Touch
Medical Monitor
Sponsor contactCONTACT