A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
NCT ID: NCT07023614
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
165 participants
INTERVENTIONAL
2025-10-06
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ninerafaxstat
Ninerafaxstat 200mg MR
Ninerafaxstat 200mg Modified Release tablet administered BID
Placebo
Placebo
Matching placebo tablet administered BID
Interventions
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Ninerafaxstat 200mg MR
Ninerafaxstat 200mg Modified Release tablet administered BID
Placebo
Matching placebo tablet administered BID
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Imbria Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Imbria Investigational Site
La Jolla, California, United States
Imbria Investigational Site
San Francisco, California, United States
Imbria Investigational Site
Burlington, Massachusetts, United States
Imbria Investigational Site
St Louis, Missouri, United States
Imbria Investigational Site
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Other Identifiers
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IMB101-010
Identifier Type: -
Identifier Source: org_study_id