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

NCT07023614 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2026-05-18

No results posted yet for this 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

Conditions

  • Non-obstructive Hypertrophic Cardiomyopathy

Interventions

DRUG

Ninerafaxstat 200mg MR

Ninerafaxstat 200mg Modified Release tablet administered BID

DRUG

Placebo

Matching placebo tablet administered BID

Sponsors & Collaborators

  • Imbria Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07023614 on ClinicalTrials.gov