NCT07023614

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Imbria Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Ninerafaxstat 200mg MR	Ninerafaxstat 200mg Modified Release tablet administered BID
DRUG	Placebo	Matching placebo tablet administered BID

Timeline

• Start date: 2025-10-06
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-06-17
• Last updated: 2026-02-09

Locations

23 sites across 6 countries: United States, France, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study