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NCT07023614 · ClinicalTrials.gov registry record · Phase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
A Phase 2 study of Non-obstructive Hypertrophic Cardiomyopathy, sponsored by Imbria Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
- 20
- Study locations
NCT07023614: Recruiting Phase 2 study of Non-obstructive Hypertrophic Cardiomyopathy, sponsored by Imbria Pharmaceuticals.
NCT07023614 is a Phase 2 study of Non-obstructive Hypertrophic Cardiomyopathy that is actively recruiting participants, run by Imbria Pharmaceuticals. The registered enrollment target is 165 participants, below the 209-participant average among 3 other Non-obstructive Hypertrophic Cardiomyopathy trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07023614, a Phase 2 study of Non-obstructive Hypertrophic Cardiomyopathy, is actively recruiting participants, sponsored by Imbria Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ninerafaxstat 200mg MR
Study Locations (20)
Other
- Imbria Investigational Site - Montpellier
- Imbria Investigational Site - Paris
- Imbria Investigational Site - Saint-Herblain
- Imbria Investigational Site - Katowice
- Imbria Investigational Site - Guimarães
- Imbria Investigational Site - Lisbon
California
- Imbria Investigational Site - La Jolla
- Imbria Investigational Site - San Francisco
Massachusetts
- Imbria Investigational Site - Boston
- Imbria Investigational Site - Burlington
District of Columbia
- Imbria Investigational Site - Washington D.C.
Illinois
- Imbria Investigational Site - Chicago
Missouri
- Imbria Investigational Site - St Louis
Texas
- Imbria Investigational Site - Houston
Virginia
- Imbria Investigational Site - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2025-10-06 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT07023614 shows while recruiting
NCT07023614 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 209-participant average among 3 other Non-obstructive Hypertrophic Cardiomyopathy trials with a reported enrollment target (21% lower).
The record links to 1 condition, with Non-obstructive Hypertrophic Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07023614 names 20 study sites across 13 states, led by Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07023614 about?
NCT07023614 is a clinical study titled "A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy". 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
What is the current status of trial NCT07023614?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2025-10-06. Estimated completion is 2026-12.
What conditions does trial NCT07023614 study?
This clinical trial studies the following conditions: Non-obstructive Hypertrophic Cardiomyopathy.
What interventions are being tested in trial NCT07023614?
The interventions under investigation include: Placebo (DRUG), Ninerafaxstat 200mg MR (DRUG).
Who is sponsoring clinical trial NCT07023614?
This trial is sponsored by Imbria Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07023614 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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