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

Part of paid clinical trials in La Jolla, California.

Sponsor
Imbria Pharmaceuticals, Inc.
Study ID
NCT07023614
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non-obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ninerafaxstat 200mg MR — DRUG
    Ninerafaxstat 200mg Modified Release tablet administered BID
  • Placebo — DRUG
    Matching placebo tablet administered BID

Study Details

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

Key Dates

Start date
Oct 6, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ninerafaxstat
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) [ Time Frame: Baseline to Week 12 ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Imbria Investigational SiteLa JollaCalifornia92037
Study Coordinator
858-246-5640
Imbria Investigational SiteLos AngelesCalifornia90048
Study Coordinator
6264094913
Imbria Investigational SiteSan FranciscoCalifornia94143
Study Coordinator
[email protected]
415-476-2060
Imbria Investigational SiteWashington D.C.District of Columbia20010
Study Coordinator
202-877-6334
Imbria Investigational SiteMiamiFlorida33136
Study Coordinator
7865785926
Imbria Investigational SiteChicagoIllinois60611
Study Coordinator
312-695-4067
Study Coordinator
312-926-8629
Imbria Investigational SiteOak LawnIllinois60453
Study Coordinator
708.684.5137
Imbria Investigational SiteBaltimoreMaryland21218
Study Coordinator
44327891702
Imbria Investigational SiteBostonMassachusetts02114
Study Coordinator
203-450-8273
Imbria Investigational SiteBurlingtonMassachusetts01805
Study Coordinator
781-825-8658
Imbria Investigational SiteGrand RapidsMichigan49503
Study Coordinator
6163910284
Imbria Investigational SiteRochesterMinnesota55905
Study Coordinator
5072844253
Imbria Investigational SiteSt LouisMissouri63110
Study Coordinator
314-362-1962
Imbria Investigational SiteNew YorkNew York10016
Study Coordinator
6465010568
Imbria Investigational SiteCharlotteNorth Carolina28204
Study Coordinator
7043554796
Imbria Investigational SitePortlandOregon97239
Study Coordinator
5034948799
Imbria Investigational SitePhiladelphiaPennsylvania19104
Study Coordinator
2156623768
Imbria Investigational SitePhiladelphiaPennsylvania19107
Study Coordinator
(215) 503-4913
Imbria Investigational SiteHoustonTexas77030
Study Coordinator
7134414960
Imbria Investigational SitePlanoTexas75093
Study Coordinator
4698144853
Imbria Investigational SiteCharlottesvilleVirginia22903
Study Coordinator
434-982-1058
Imbria Investigational SiteRichmondVirginia23298
Study Coordinator
8048281601

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Imbria Investigational Site· La Jolla, CAImbria Investigational Site· Los Angeles, CAImbria Investigational Site· San Francisco, CAImbria Investigational Site· Washington D.C., DCImbria Investigational Site· Miami, FLImbria Investigational Site· Chicago, IL

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