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

ClinicalTrials.gov ID

NCT07023614

Lead Sponsor

Imbria Pharmaceuticals, Inc.INDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

165Estimated

Last Update Posted

May 18, 2026Actual

Start Date

Oct 6, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

Official Title

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

Brief 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

• Non-obstructive Hypertrophic Cardiomyopathy

• Ninerafaxstat 200mg MR
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Imbria Pharmaceuticals, Inc.INDUSTRY

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