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Non-obstructive Hypertrophic CardiomyopathyPhase 2FORTITUDE-HCMNCT07023614

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

A Phase 2 study testing Ninerafaxstat 200mg MR in people with Non-obstructive Hypertrophic Cardiomyopathy, run by Imbria Pharmaceuticals, Inc. at 67 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ninerafaxstat 200mg MR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
67 sitesin 11 countries
Study dates
6 Oct 2025to Dec 2026
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

67 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Medical Monitor contact

(617) 675-4060

info@imbria.com

67 sites in 11 countries

United States22 sites, 22 recruiting

  • Imbria Investigational Site

    Baltimore, Maryland, 21218

    Study Coordinator

    44327891702

    Recruiting

  • Imbria Investigational Site

    Boston, Massachusetts, 02114

    Study Coordinator, 203-450-8273

    Recruiting

  • Imbria Investigational Site

    Burlington, Massachusetts, 01805

    Study Coordinator, 781-825-8658

    Recruiting

  • Imbria Investigational Site

    Charlotte, North Carolina, 28204

    Study Coordinator, 7043554796

    Recruiting

  • Imbria Investigational Site

    Charlottesville, Virginia, 22903

    Study Coordinator, 434-982-1058

    Recruiting

  • Imbria Investigational Site

    Chicago, Illinois, 60611

    Study Coordinator, 312-695-4067

    Study Coordinator, 312-926-8629

    Recruiting

  • Imbria Investigational Site

    Grand Rapids, Michigan, 49503

    Study Coordinator, 6163910284

    Recruiting

  • Imbria Investigational Site

    Houston, Texas, 77030

    Study Coordinator, 7134414960

    Recruiting

  • Imbria Investigational Site

    La Jolla, California, 92037

    Study Coordinator, 858-246-5640

    Recruiting

  • Imbria Investigational Site

    Los Angeles, California, 90048

    Study Coordinator, 6264094913

    Recruiting

  • Imbria Investigational Site

    Miami, Florida, 33136

    Study Coordinator, 7865785926

    Recruiting

  • Imbria Investigational Site

    New York, New York, 10016

    Study Coordinator, 6465010568

    Recruiting

  • Imbria Investigational Site

    Oak Lawn, Illinois, 60453

    Study Coordinator, 708.684.5137

    Not yet recruiting

  • Imbria Investigational Site

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 2156623768

    Recruiting

  • Imbria Investigational Site

    Philadelphia, Pennsylvania, 19107

    Study Coordinator, (215) 503-4913

    Recruiting

  • Imbria Investigational Site

    Plano, Texas, 75093

    Study Coordinator, 4698144853

    Recruiting

  • Imbria Investigational Site

    Portland, Oregon, 97239

    Study Coordinator, 5034948799

    Recruiting

  • Imbria Investigational Site

    Richmond, Virginia, 23298

    Study Coordinator, 8048281601

    Recruiting

  • Imbria Investigational Site

    Rochester, Minnesota, 55905

    Study Coordinator, 5072844253

    Recruiting

  • Imbria Investigational Site

    San Francisco, California, 94143

    Study Coordinator, 415-476-2060, Jonathan.Thomas2@ucsf.edu

    Recruiting

  • Imbria Investigational Site

    St Louis, Missouri, 63110

    Study Coordinator, 314-362-1962

    Recruiting

  • Imbria Investigational Site

    Washington D.C., District of Columbia, 20010

    Study Coordinator, 202-877-6334

    Recruiting

Other trials in United States

Spain15 sites, 15 recruiting

  • Imbria Investigational Site

    A Coruña, Galicia, 15006

    Study Coordinator, +34 981 176 540

    Recruiting

  • Imbria Investigational Site

    Barcelona, Barcelona, 08035

    Study Coordinator, +34 677 381 128

    Recruiting

  • Imbria Investigational Site

    Barcelona, 8036

    Study Coordinator, 3463329611

    Recruiting

  • Imbria Investigational Site

    Barcelona, 8041

    Study Coordinator, 3493291900

    Recruiting

  • Imbria Investigational Site

    Barcelona, 8907

    Study Coordinator, 9326073202108

    Recruiting

  • Imbria Investigational Site

    El Palmar, 30120

    Study Coordinator, 34689931292

    Recruiting

  • Imbria Investigational Site

    Madrid, Madrid, 28034

    Study Coordinator, 34 913 368 954

    Recruiting

  • Imbria Investigational Site

    Madrid, 28222

    Study Coordinator, 34911917297

    Recruiting

  • Imbria Investigational Site

    Palma de Mallorca, 07198

    Study Coordinator, 34871202102

    Recruiting

  • Imbria Investigational Site

    Salamanca, 37007

    Study Coordinator, 34658403315

    Recruiting

  • Imbria Investigational Site

    Seville, Sevilla, 41009

    Study Coordinator, 34 600 162 398

    Recruiting

  • Imbria Investigational Site

    Seville, Sevilla, 41013

    Study Coordinator, +34 955 013 105

    Recruiting

  • Imbria Investigational Site

    Valencia, 03010

    Study Coordinator, 34965913678

    Recruiting

  • Imbria Investigational Site

    Valencia, 46026

    Study Coordinator, 34965913921

    Recruiting

  • Imbria Investigational Site

    Vigo, Pontevedra, 36312

    Study Coordinator

    Recruiting

Other trials in Spain

Italy6 sites, 6 recruiting

  • Imbria Investigational Site

    Florence, 50139

    Study Coordinator, 390557945138

    Recruiting

  • Imbria Investigational Site

    Massa, 54100

    Study Coordinator, 393277861790

    Recruiting

  • Imbria Investigational Site

    Milan, 20131

    Study Coordinator, 390264447940

    Recruiting

  • Imbria Investigational Site

    Milan, 20146

    Study Coordinator, +39 02619112895

    Recruiting

  • Imbria Investigational Site

    Milan, 20162

    Study Coordinator, +39 0264446715

    Recruiting

  • Imbria Investigational Site

    Naples, 80131

    Study Coordinator, +39 3357621204

    Recruiting

Other trials in Italy

United Kingdom5 sites, 5 recruiting

  • Imbria Investigational Site

    Glasgow, Scotland, G51 4TF

    Study Coordinator, 44-141 232 7600

    Recruiting

  • Imbria Investigational Site

    London, England, W12 0HS

    Study Coordinator, 44 020 3313 7156

    Recruiting

  • Imbria Investigational Site

    London, EC1A 7BE

    Study Coordinator, 442037658635

    Recruiting

  • Imbria Investigational Site

    London, SW3 6HP

    Study Coordinator, 4403301288121

    Recruiting

  • Imbria Investigational Site

    Oxford, OX3 9DU

    Study Coordinator, 441865234554

    Recruiting

Other trials in United Kingdom

Germany4 sites, 4 recruiting

  • Imbria Investigational Site

    Bad Oeynhausen, 32545

    Study Coordinator, 495731973399

    Recruiting

  • Imbria Investigational Site

    Göttingen, 37075

    Study Coordinator, 4905513962720

    Recruiting

  • Imbria Investigational Site

    Heidelberg, 69120

    Study Coordinator, 4962215638336

    Recruiting

  • Imbria Investigational Site

    Jena, 07747

    Study Coordinator, 4915232184941

    Not yet recruiting

Other trials in Germany

Netherlands4 sites, 4 recruiting

  • Imbria Investigational Site

    Amsterdam-Zuidoost, 1105 AZ

    Study Coordinator, 310204444912

    Recruiting

  • Imbria Investigational Site

    Leiden, 2333ZC

    Study Coordinator, 31715263009

    Not yet recruiting

  • Imbria Investigational Site

    Nijmegen, 6525 GA

    Study Coordinator, 31243616785

    Not yet recruiting

  • Imbria Investigational Site

    Rotterdam, 3015 AA

    Study Coordinator, +31 10 704 0 704

    Recruiting

Other trials in Netherlands

France3 sites, 3 recruiting

  • Imbria Investigational Site

    Montpellier, 34295

    Study Coordinator, +33 467 336 431

    Recruiting

  • Imbria Investigational Site

    Paris, 75015

    Study Coordinator, 33 1 56 09 27 27

    Recruiting

  • Imbria Investigational Site

    Saint-Herblain, 44800

    Study Coordinator, +33 240 165 710

    Recruiting

Other trials in France

Poland3 sites, 3 recruiting

  • Imbria Investigational Site

    Katowice, 40-555

    Study Coordinator, +48 604 122 669

    Recruiting

  • Imbria Investigational Site

    Warsaw, 02-507

    Study Coordinator, 48227221113

    Recruiting

  • Imbria Investigational Site

    Wroclaw, 53-114

    Study Coordinator, 48 517 311 583

    Recruiting

Other trials in Poland

Portugal3 sites, 3 recruiting

  • Imbria Investigational Site

    Guimarães, 4835-044

    Study Coordinator

    Recruiting

  • Imbria Investigational Site

    Lisbon, 1169-024

    Study Coordinator

    Recruiting

  • Imbria Investigational Site

    Lisbon, 1500-650

    Study Coordinator, 351969870409

    Recruiting

Other trials in Portugal

Austria1 site, 1 recruiting

  • Imbria Investigational Site

    Graz, 8036

    Study Coordinator, 4331638580264

    Recruiting

Other trials in Austria

Belgium1 site, 1 recruiting

  • Imbria Investigational Site

    Edegem, 2650

    Study Coordinator, 3238213000

    Recruiting

Other trials in Belgium

About this study

Official title: A Global Phase 2b, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy - FORTITUDE-HCM

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

Being tested
Ninerafaxstat 200mg MR, Placebo
Keywords
nHCM, non-obstructive HCM, non-obstructive hypertrophic cardiomyopathy, HCM, hypertrophic cardiomyopathy
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ninerafaxstat 200mg MRDrug

    Ninerafaxstat 200mg Modified Release tablet administered BID

  • PlaceboDrug

    Matching placebo tablet administered BID

Study groups in NCT07023614
Study groupRoleWhat they receive
NinerafaxstatExperimentalNot described
Receives: Drug: Ninerafaxstat 200mg MR
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)

    The Clinical Summary Score is a merging of symptom frequency and symptom burden domains into a total symptom score combined with the physical limitation domain. Scoring ranges from 0 to 100, with higher scores indicating better health status.

    Measured: Baseline to Week 12

Secondary outcomes (4)

  1. Change in ventilatory efficiency (VE/VCO2 slope) during cardiopulmonary exercise testing (CPET)

    Measured: Baseline to Week 12

  2. Change in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)

    The Total Symptom Score is a merging of symptom frequency and symptom burden domains. Scoring ranges from 0 to 100, with higher scores indicating better health status.

    Measured: Baseline to Week 12

  3. Change in the Kansas City Cardiomyopathy Questionnaire Physical Limitations Score (KCCQ-PLS)

    The Physical Limitations Score is a single-domain score. Scoring ranges from 0 to 100, with higher scores indicating better health status.

    Measured: Baseline to Week 12

  4. Change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS)

    The Overall Summary Score is a merging of symptom, physical limitations, social limitations, and quality of life domains. Scoring ranges from 0 to 100, with higher scores indicating better health status.

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start6 Oct 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07023614
Sponsor's protocol ID
IMB101-010
Acronym
FORTITUDE-HCM
Status last verified
May 2026
First submitted
9 Jun 2025
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

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