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NCT07023614PHASE2Recruiting

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

Imbria Pharmaceuticals, Inc.

Start Date

10/6/2025

Completion Date

12/1/2026

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Ninerafaxstat 200mg MR

DRUG

Placebo

Interested in This Trial?

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Conditions

Non-obstructive Hypertrophic Cardiomyopathy

Locations

Imbria Investigational Site

La Jolla, California 92037

United States

Imbria Investigational Site

Los Angeles, California 90048

United States

Imbria Investigational Site

San Francisco, California 94143

United States

Imbria Investigational Site

Washington D.C., District of Columbia 20010

United States

Imbria Investigational Site

Miami, Florida 33136

United States

Imbria Investigational Site

Chicago, Illinois 60611

United States

Imbria Investigational Site

Oak Lawn, Illinois 60453

United States

Imbria Investigational Site

Baltimore, Maryland 21218

United States

Imbria Investigational Site

Boston, Massachusetts 02114

United States

Imbria Investigational Site

Burlington, Massachusetts 01805

United States

Imbria Investigational Site

Grand Rapids, Michigan 49503

United States

Imbria Investigational Site

Rochester, Minnesota 55905

United States

Imbria Investigational Site

St Louis, Missouri 63110

United States

Imbria Investigational Site

New York, New York 10016

United States

Imbria Investigational Site

Charlotte, North Carolina 28204

United States

Imbria Investigational Site

Portland, Oregon 97239

United States

Imbria Investigational Site

Philadelphia, Pennsylvania 19104

United States

Imbria Investigational Site

Philadelphia, Pennsylvania 19107

United States

Imbria Investigational Site

Houston, Texas 77030

United States

Imbria Investigational Site

Plano, Texas 75093

United States

Imbria Investigational Site

Charlottesville, Virginia 22903

United States

Imbria Investigational Site

Richmond, Virginia 23298

United States

Imbria Investigational Site

Graz, 8036

Austria

Imbria Investigational Site

Edegem, 2650

Belgium

Imbria Investigational Site

Montpellier, 34295

France

Imbria Investigational Site

Paris, 75015

France

Imbria Investigational Site

Saint-Herblain, 44800

France

Imbria Investigational Site

Bad Oeynhausen, 32545

Germany

Imbria Investigational Site

Göttingen, 37075

Germany

Imbria Investigational Site

Heidelberg, 69120

Germany

Imbria Investigational Site

Jena, 07747

Germany

Imbria Investigational Site

Florence, 50139

Italy

Imbria Investigational Site

Massa, 54100

Italy

Imbria Investigational Site

Milan, 20131

Italy

Imbria Investigational Site

Milan, 20146

Italy

Imbria Investigational Site

Milan, 20162

Italy

Imbria Investigational Site

Naples, 80131

Italy

Imbria Investigational Site

Amsterdam-Zuidoost, 1105 AZ

Netherlands

Imbria Investigational Site

Leiden, 2333ZC

Netherlands

Imbria Investigational Site

Nijmegen, 6525 GA

Netherlands

Imbria Investigational Site

Rotterdam, 3015 AA

Netherlands

Imbria Investigational Site

Katowice, 40-555

Poland

Imbria Investigational Site

Warsaw, 02-507

Poland

Imbria Investigational Site

Wroclaw, 53-114

Poland

Imbria Investigational Site

Guimarães, 4835-044

Portugal

Imbria Investigational Site

Lisbon, 1169-024

Portugal

Imbria Investigational Site

Lisbon, 1500-650

Portugal

Imbria Investigational Site

Barcelona, Barcelona 08035

Spain

Imbria Investigational Site

A Coruña, Galicia 15006

Spain

Imbria Investigational Site

Madrid, Madrid 28034

Spain

Imbria Investigational Site

Vigo, Pontevedra 36312

Spain

Imbria Investigational Site

Seville, Sevilla 41009

Spain

Imbria Investigational Site

Seville, Sevilla 41013

Spain

Imbria Investigational Site

Barcelona, 8036

Spain

Imbria Investigational Site

Barcelona, 8041

Spain

Imbria Investigational Site

Barcelona, 8907

Spain

Imbria Investigational Site

El Palmar, 30120

Spain

Imbria Investigational Site

Madrid, 28222

Spain

Imbria Investigational Site

Palma de Mallorca, 07198

Spain

Imbria Investigational Site

Salamanca, 37007

Spain

Imbria Investigational Site

Valencia, 03010

Spain

Imbria Investigational Site

Valencia, 46026

Spain

Imbria Investigational Site

London, England W12 0HS

United Kingdom

Imbria Investigational Site

Glasgow, Scotland 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