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RecruitingPhase 2

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

Imbria Pharmaceuticals, Inc. · NCT07023614

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
165
US sites recruiting
21
Study start
October 6, 2025
Record last updated
May 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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

Being studied: Ninerafaxstat 200mg MR; Placebo

Conditions: Non-obstructive Hypertrophic Cardiomyopathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Imbria Investigational Site

    La Jolla, CA 92037

    Site contact: Study Coordinator · 858-246-5640

  • Imbria Investigational Site

    Los Angeles, CA 90048

    Site contact: Study Coordinator · 6264094913

  • Imbria Investigational Site

    San Francisco, CA 94143

    Site contact: Study Coordinator · 415-476-2060 · Jonathan.Thomas2@ucsf.edu

  • Imbria Investigational Site

    Washington D.C., DC 20010

    Site contact: Study Coordinator · 202-877-6334

  • Imbria Investigational Site

    Miami, FL 33136

    Site contact: Study Coordinator · 7865785926

  • Imbria Investigational Site

    Chicago, IL 60611

    Site contact: Study Coordinator · 312-695-4067

  • Imbria Investigational Site

    Baltimore, MD 21218

    Site contact: Study Coordinator

  • Imbria Investigational Site

    Boston, MA 02114

    Site contact: Study Coordinator · 203-450-8273

  • Imbria Investigational Site

    Burlington, MA 01805

    Site contact: Study Coordinator · 781-825-8658

  • Imbria Investigational Site

    Grand Rapids, MI 49503

    Site contact: Study Coordinator · 6163910284

  • Imbria Investigational Site

    Rochester, MN 55905

    Site contact: Study Coordinator · 5072844253

  • Imbria Investigational Site

    St Louis, MO 63110

    Site contact: Study Coordinator · 314-362-1962

  • Imbria Investigational Site

    New York, NY 10016

    Site contact: Study Coordinator · 6465010568

  • Imbria Investigational Site

    Charlotte, NC 28204

    Site contact: Study Coordinator · 7043554796

  • Imbria Investigational Site

    Portland, OR 97239

    Site contact: Study Coordinator · 5034948799

  • Imbria Investigational Site

    Philadelphia, PA 19104

    Site contact: Study Coordinator · 2156623768

  • Imbria Investigational Site

    Philadelphia, PA 19107

    Site contact: Study Coordinator · (215) 503-4913

  • Imbria Investigational Site

    Houston, TX 77030

    Site contact: Study Coordinator · 7134414960

  • Imbria Investigational Site

    Plano, TX 75093

    Site contact: Study Coordinator · 4698144853

  • Imbria Investigational Site

    Charlottesville, VA 22903

    Site contact: Study Coordinator · 434-982-1058

  • Imbria Investigational Site

    Richmond, VA 23298

    Site contact: Study Coordinator · 8048281601

Study contacts (from the official record)

  • Medical Monitor · (617) 675-4060 · info@imbria.com
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A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in… (NCT07023614) | Bored Studies