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New drug aims to ease symptoms of stiff heart muscle

NCT ID NCT07023614

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a drug called ninerafaxstat in people with a type of heart muscle disease that makes the heart stiff and causes symptoms like shortness of breath and fatigue. The trial involves 165 participants who will receive either the drug or a placebo. The main goal is to see if the drug improves quality of life and exercise ability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ninerafaxstat
What this could lead to
If successful, this could lead to a new treatment option that eases symptoms and improves daily life for people with this type of heart disease.
What could go wrong
This is a mid-stage trial with only 165 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 165 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    67 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Imbria Investigational Site

    RECRUITING

    La Jolla, California, 92037, United States

  • Imbria Investigational Site

    RECRUITING

    Los Angeles, California, 90048, United States

  • Imbria Investigational Site

    RECRUITING

    San Francisco, California, 94143, United States

  • Imbria Investigational Site

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Imbria Investigational Site

    RECRUITING

    Miami, Florida, 33136, United States

  • Imbria Investigational Site

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Imbria Investigational Site

    NOT_YET_RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Imbria Investigational Site

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Imbria Investigational Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Imbria Investigational Site

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Imbria Investigational Site

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Imbria Investigational Site

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Imbria Investigational Site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Imbria Investigational Site

    RECRUITING

    New York, New York, 10016, United States

  • Imbria Investigational Site

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Imbria Investigational Site

    RECRUITING

    Portland, Oregon, 97239, United States

  • Imbria Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Imbria Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Imbria Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Imbria Investigational Site

    RECRUITING

    Plano, Texas, 75093, United States

  • Imbria Investigational Site

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Imbria Investigational Site

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Imbria Investigational Site

    RECRUITING

    Graz, 8036, Austria

  • Imbria Investigational Site

    RECRUITING

    Edegem, 2650, Belgium

  • Imbria Investigational Site

    RECRUITING

    Montpellier, 34295, France

  • Imbria Investigational Site

    RECRUITING

    Paris, 75015, France

  • Imbria Investigational Site

    RECRUITING

    Saint-Herblain, 44800, France

  • Imbria Investigational Site

    RECRUITING

    Bad Oeynhausen, 32545, Germany

  • Imbria Investigational Site

    RECRUITING

    Göttingen, 37075, Germany

  • Imbria Investigational Site

    RECRUITING

    Heidelberg, 69120, Germany

  • Imbria Investigational Site

    NOT_YET_RECRUITING

    Jena, 07747, Germany

  • Imbria Investigational Site

    RECRUITING

    Florence, 50139, Italy

  • Imbria Investigational Site

    RECRUITING

    Massa, 54100, Italy

  • Imbria Investigational Site

    RECRUITING

    Milan, 20131, Italy

  • Imbria Investigational Site

    RECRUITING

    Milan, 20146, Italy

  • Imbria Investigational Site

    RECRUITING

    Milan, 20162, Italy

  • Imbria Investigational Site

    RECRUITING

    Naples, 80131, Italy

  • Imbria Investigational Site

    RECRUITING

    Amsterdam-Zuidoost, 1105 AZ, Netherlands

  • Imbria Investigational Site

    NOT_YET_RECRUITING

    Leiden, 2333ZC, Netherlands

  • Imbria Investigational Site

    NOT_YET_RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Imbria Investigational Site

    RECRUITING

    Rotterdam, 3015 AA, Netherlands

  • Imbria Investigational Site

    RECRUITING

    Katowice, 40-555, Poland

  • Imbria Investigational Site

    RECRUITING

    Warsaw, 02-507, Poland

  • Imbria Investigational Site

    RECRUITING

    Wroclaw, 53-114, Poland

  • Imbria Investigational Site

    RECRUITING

    Guimarães, 4835-044, Portugal

  • Imbria Investigational Site

    RECRUITING

    Lisbon, 1169-024, Portugal

  • Imbria Investigational Site

    RECRUITING

    Lisbon, 1500-650, Portugal

  • Imbria Investigational Site

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Imbria Investigational Site

    RECRUITING

    A Coruña, Galicia, 15006, Spain

  • Imbria Investigational Site

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Imbria Investigational Site

    RECRUITING

    Vigo, Pontevedra, 36312, Spain

  • Imbria Investigational Site

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Imbria Investigational Site

    RECRUITING

    Seville, Sevilla, 41013, Spain

  • Imbria Investigational Site

    RECRUITING

    Barcelona, 8036, Spain

  • Imbria Investigational Site

    RECRUITING

    Barcelona, 8041, Spain

  • Imbria Investigational Site

    RECRUITING

    Barcelona, 8907, Spain

  • Imbria Investigational Site

    RECRUITING

    El Palmar, 30120, Spain

  • Imbria Investigational Site

    RECRUITING

    Madrid, 28222, Spain

  • Imbria Investigational Site

    RECRUITING

    Palma de Mallorca, 07198, Spain

  • Imbria Investigational Site

    RECRUITING

    Salamanca, 37007, Spain

  • Imbria Investigational Site

    RECRUITING

    Valencia, 03010, Spain

  • Imbria Investigational Site

    RECRUITING

    Valencia, 46026, Spain

  • Imbria Investigational Site

    RECRUITING

    London, England, W12 0HS, United Kingdom

  • Imbria Investigational Site

    RECRUITING

    Glasgow, Scotland, G51 4TF, United Kingdom

  • Imbria Investigational Site

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Imbria Investigational Site

    RECRUITING

    London, SW3 6HP, United Kingdom

  • Imbria Investigational Site

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

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