Recruiting

Phase 2

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

Sponsor:

Imbria Pharmaceuticals, Inc.

Code:

NCT07023614

Conditions

Non-obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ninerafaxstat 200mg MR

Placebo

Study Details

Brief 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

Study ID

NCT07023614

Start date

Oct 6, 2025

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Select Inclusion Criteria:

Has a clinical diagnosis of HCM consistent with current American College of Cardiology/American Heart Association and European Society of Cardiology Guideline definitions
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

Select Exclusion Criteria:

Has a known or suspected infiltrative, genetic, or storage disorder causing cardiac hypertrophy that mimics nHCM
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

Other protocol-defined inclusion and exclusion criteria apply.

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ninerafaxstat

placebo comparator: Placebo

Interventions

Ninerafaxstat 200mg MR

Ninerafaxstat 200mg Modified Release tablet administered BID

Placebo

Matching placebo tablet administered BID

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Medical Monitor

(617) 675-4060 info@imbria.com

Locations

Imbria Investigational Site

Recruiting

La Jolla, California, United States, 92037

Contacts

Study Coordinator

858-246-5640

Imbria Investigational Site

Recruiting

Los Angeles, California, United States, 90048

Contacts

Study Coordinator

6264094913

Imbria Investigational Site

Recruiting

San Francisco, California, United States, 94143

Contacts

Study Coordinator

415-476-2060 Jonathan.Thomas2@ucsf.edu

Imbria Investigational Site

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Study Coordinator

202-877-6334

Imbria Investigational Site

Recruiting

Miami, Florida, United States, 33136

Contacts

Study Coordinator

7865785926

Imbria Investigational Site

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Study Coordinator

312-695-4067

Study Coordinator

312-926-8629

Imbria Investigational Site

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

44327891702

Imbria Investigational Site

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Study Coordinator

203-450-8273

Imbria Investigational Site

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Study Coordinator

781-825-8658

Imbria Investigational Site

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Study Coordinator

6163910284

Imbria Investigational Site

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Study Coordinator

5072844253

Imbria Investigational Site

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

314-362-1962

Imbria Investigational Site

Recruiting

New York, New York, United States, 10016

Contacts

Study Coordinator

6465010568

Imbria Investigational Site

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Study Coordinator

7043554796

Imbria Investigational Site

Recruiting

Portland, Oregon, United States, 97239

Contacts

Study Coordinator

5034948799

Imbria Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

2156623768

Imbria Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Study Coordinator

(215) 503-4913

Imbria Investigational Site

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

7134414960

Imbria Investigational Site

Recruiting

Plano, Texas, United States, 75093

Contacts

Study Coordinator

4698144853

Imbria Investigational Site

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Study Coordinator

434-982-1058

Imbria Investigational Site

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Study Coordinator

8048281601

More Information

Sponsor

Imbria Pharmaceuticals, Inc.

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

nHCM
non-obstructive HCM
non-obstructive hypertrophic cardiomyopathy
HCM
hypertrophic cardiomyopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Imbria Pharmaceuticals, Inc. on 2026-05-18.