RecruitingPhase 2NCT07023614

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

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

Sponsor

Imbria Pharmaceuticals, Inc.

Enrollment

165 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Non-obstructive Hypertrophic Cardiomyopathy

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ninerafaxstat 200mg MR and a drug called Placebo for people with non-obstructive hypertrophic cardiomyopathy. The study is currently recruiting participants at 67 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNinerafaxstat 200mg MR

Ninerafaxstat 200mg Modified Release tablet administered BID

DRUGPlacebo

Matching placebo tablet administered BID

Locations(67)

Imbria Investigational Site

La Jolla, California, United States

Imbria Investigational Site

Los Angeles, California, United States

Imbria Investigational Site

San Francisco, California, United States

Imbria Investigational Site

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

Imbria Investigational Site

Miami, Florida, United States

Imbria Investigational Site

Chicago, Illinois, United States

Imbria Investigational Site

Oak Lawn, Illinois, United States

Imbria Investigational Site

Baltimore, Maryland, United States

Imbria Investigational Site

Boston, Massachusetts, United States

Imbria Investigational Site

Burlington, Massachusetts, United States

Imbria Investigational Site

Grand Rapids, Michigan, United States

Imbria Investigational Site

Rochester, Minnesota, United States

Imbria Investigational Site

St Louis, Missouri, United States

Imbria Investigational Site

New York, New York, United States

Imbria Investigational Site

Charlotte, North Carolina, United States

Imbria Investigational Site

Portland, Oregon, United States

Imbria Investigational Site

Philadelphia, Pennsylvania, United States

Imbria Investigational Site

Philadelphia, Pennsylvania, United States

Imbria Investigational Site

Houston, Texas, United States

Imbria Investigational Site

Plano, Texas, United States

Imbria Investigational Site

Charlottesville, Virginia, United States

Imbria Investigational Site

Richmond, Virginia, United States

Imbria Investigational Site

Graz, Austria

Imbria Investigational Site

Edegem, Belgium

Imbria Investigational Site

Montpellier, France

Imbria Investigational Site

Paris, France

Imbria Investigational Site

Saint-Herblain, France

Imbria Investigational Site

Bad Oeynhausen, Germany

Imbria Investigational Site

Göttingen, Germany

Imbria Investigational Site

Heidelberg, Germany

Imbria Investigational Site

Jena, Germany

Imbria Investigational Site

Florence, Italy

Imbria Investigational Site

Massa, Italy

Imbria Investigational Site

Milan, Italy

Imbria Investigational Site

Milan, Italy

Imbria Investigational Site

Milan, Italy

Imbria Investigational Site

Naples, Italy

Imbria Investigational Site

Amsterdam-Zuidoost, Netherlands

Imbria Investigational Site

Leiden, Netherlands

Imbria Investigational Site

Nijmegen, Netherlands

Imbria Investigational Site

Rotterdam, Netherlands

Imbria Investigational Site

Katowice, Poland

Imbria Investigational Site

Warsaw, Poland

Imbria Investigational Site

Wroclaw, Poland

Imbria Investigational Site

Guimarães, Portugal

Imbria Investigational Site

Lisbon, Portugal

Imbria Investigational Site

Lisbon, Portugal

Imbria Investigational Site

Barcelona, Barcelona, Spain

Imbria Investigational Site

A Coruña, Galicia, Spain

Imbria Investigational Site

Madrid, Madrid, Spain

Imbria Investigational Site

Vigo, Pontevedra, Spain

Imbria Investigational Site

Seville, Sevilla, Spain

Imbria Investigational Site

Seville, Sevilla, Spain

Imbria Investigational Site

Barcelona, Spain

Imbria Investigational Site

Barcelona, Spain

Imbria Investigational Site

Barcelona, Spain

Imbria Investigational Site

El Palmar, Spain

Imbria Investigational Site

Madrid, Spain

Imbria Investigational Site

Palma de Mallorca, Spain

Imbria Investigational Site

Salamanca, Spain

Imbria Investigational Site

Valencia, Spain

Imbria Investigational Site

Valencia, Spain

Imbria Investigational Site

London, England, United Kingdom

Imbria Investigational Site

Glasgow, Scotland, United Kingdom

Imbria Investigational Site

London, United Kingdom

Imbria Investigational Site

London, United Kingdom

Imbria Investigational Site

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07023614

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