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

NCT07023614 · tracked via the Priya Life Science UK tracker

Sponsor

Imbria Pharmaceuticals, Inc.

Phase

Phase 2

Started

2025-10-06

Last updated

2026-05-18

Condition(s) studied

Non-obstructive Hypertrophic Cardiomyopathy

Investigational drug(s) / intervention(s)

Ninerafaxstat 200mg MRPlacebo

Ninerafaxstat 200mg MR: Ninerafaxstat 200mg Modified Release tablet administered BID

Placebo: Matching placebo tablet administered BID

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) — Baseline to Week 12
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.

Trial sites (67)

Facility	City	Region	Status
Imbria Investigational Site	La Jolla	California	Recruiting
Imbria Investigational Site	Los Angeles	California	Recruiting
Imbria Investigational Site	San Francisco	California	Recruiting
Imbria Investigational Site	Washington D.C.	District of Columbia	Recruiting
Imbria Investigational Site	Miami	Florida	Recruiting
Imbria Investigational Site	Chicago	Illinois	Recruiting
Imbria Investigational Site	Oak Lawn	Illinois	Not Yet Recruiting
Imbria Investigational Site	Baltimore	Maryland	Recruiting
Imbria Investigational Site	Boston	Massachusetts	Recruiting
Imbria Investigational Site	Burlington	Massachusetts	Recruiting
Imbria Investigational Site	Grand Rapids	Michigan	Recruiting
Imbria Investigational Site	Rochester	Minnesota	Recruiting
Imbria Investigational Site	St Louis	Missouri	Recruiting
Imbria Investigational Site	New York	New York	Recruiting
Imbria Investigational Site	Charlotte	North Carolina	Recruiting
Imbria Investigational Site	Portland	Oregon	Recruiting
Imbria Investigational Site	Philadelphia	Pennsylvania	Recruiting
Imbria Investigational Site	Philadelphia	Pennsylvania	Recruiting
Imbria Investigational Site	Houston	Texas	Recruiting
Imbria Investigational Site	Plano	Texas	Recruiting
Imbria Investigational Site	Charlottesville	Virginia	Recruiting
Imbria Investigational Site	Richmond	Virginia	Recruiting
Imbria Investigational Site	Graz	Austria	Recruiting
Imbria Investigational Site	Edegem	Belgium	Recruiting
Imbria Investigational Site	Montpellier	France	Recruiting
Imbria Investigational Site	Paris	France	Recruiting
Imbria Investigational Site	Saint-Herblain	France	Recruiting
Imbria Investigational Site	Bad Oeynhausen	Germany	Recruiting
Imbria Investigational Site	Göttingen	Germany	Recruiting
Imbria Investigational Site	Heidelberg	Germany	Recruiting
Imbria Investigational Site	Jena	Germany	Not Yet Recruiting
Imbria Investigational Site	Florence	Italy	Recruiting
Imbria Investigational Site	Massa	Italy	Recruiting
Imbria Investigational Site	Milan	Italy	Recruiting
Imbria Investigational Site	Milan	Italy	Recruiting
Imbria Investigational Site	Milan	Italy	Recruiting
Imbria Investigational Site	Naples	Italy	Recruiting
Imbria Investigational Site	Amsterdam-Zuidoost	Netherlands	Recruiting
Imbria Investigational Site	Leiden	Netherlands	Not Yet Recruiting
Imbria Investigational Site	Nijmegen	Netherlands	Not Yet Recruiting

+ 27 more sites — see the full list on the official registry below.

Other trials for the same condition

A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07023614 on ClinicalTrials.gov ↗ ← All trials in the UK