Actively Recruiting
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
Led by Imbria Pharmaceuticals, Inc. · Updated on 2026-05-18
165
Participants Needed
67
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ninerafaxstat in adults with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), a heart condition characterized by thickened heart muscle without obstruction. This global Phase 2b study aims to assess the safety and effectiveness of ninerafaxstat compared to a placebo, both given alongside standard care, to improve symptoms and heart function. The trial is double-blinded and placebo-controlled to ensure reliable comparisons between groups. Participants will be randomly assigned to receive either ninerafaxstat 200mg modified release tablets or matching placebo tablets, both taken twice daily. The study treatment will be given over a 12-week period. This design helps researchers observe how ninerafaxstat performs against placebo while maintaining standard therapies for nHCM. During the study, participants will undergo assessments including cardiopulmonary exercise testing and completion of the Kansas City Cardiomyopathy Questionnaire to track symptoms, physical limitations, and overall health status. The main focus is on changes in the questionnaire's clinical summary score from baseline to week 12. Safety and tolerability will also be monitored throughout the trial, which is expected to run until December 2026.
CONDITIONS
Brief Title
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Clinical diagnosis of hypertrophic cardiomyopathy according to current guidelines
- Confirmation of non-obstructive hypertrophic cardiomyopathy by echocardiography core laboratory
- New York Heart Association (NYHA) functional Class II or III at screening
- Functional limitation confirmed by cardiopulmonary exercise testing
You will not qualify if you...
- Known or suspected infiltrative, genetic, or storage disorder causing cardiac hypertrophy mimicking non-obstructive hypertrophic cardiomyopathy
- Other conditions judged as the primary cause of shortness of breath, exercise intolerance, or chest pain
- Inability to exercise on treadmill or bicycle due to orthopedic or other limitations
- Any medical condition that prevents upright exercise stress testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive Ninerafaxstat or placebo tablets twice daily as part of the trial treatment.
Baseline visit and periodic visits during treatment
Trial Site Locations
Total: 67 locations
1
Imbria Investigational Site
La Jolla, California, United States, 92037
Actively Recruiting
2
Imbria Investigational Site
Los Angeles, California, United States, 90048
Actively Recruiting
3
Imbria Investigational Site
San Francisco, California, United States, 94143
Actively Recruiting
4
Imbria Investigational Site
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Imbria Investigational Site
Miami, Florida, United States, 33136
Actively Recruiting
6
Imbria Investigational Site
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Imbria Investigational Site
Oak Lawn, Illinois, United States, 60453
Not Yet Recruiting
8
Imbria Investigational Site
Baltimore, Maryland, United States, 21218
Actively Recruiting
9
Imbria Investigational Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
10
Imbria Investigational Site
Burlington, Massachusetts, United States, 01805
Actively Recruiting
11
Imbria Investigational Site
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
12
Imbria Investigational Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
13
Imbria Investigational Site
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Imbria Investigational Site
New York, New York, United States, 10016
Actively Recruiting
15
Imbria Investigational Site
Charlotte, North Carolina, United States, 28204
Actively Recruiting
16
Imbria Investigational Site
Portland, Oregon, United States, 97239
Actively Recruiting
17
Imbria Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
18
Imbria Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
19
Imbria Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
20
Imbria Investigational Site
Plano, Texas, United States, 75093
Actively Recruiting
21
Imbria Investigational Site
Charlottesville, Virginia, United States, 22903
Actively Recruiting
22
Imbria Investigational Site
Richmond, Virginia, United States, 23298
Actively Recruiting
23
Imbria Investigational Site
Graz, Austria, 8036
Actively Recruiting
24
Imbria Investigational Site
Edegem, Belgium, 2650
Actively Recruiting
25
Imbria Investigational Site
Montpellier, France, 34295
Actively Recruiting
26
Imbria Investigational Site
Paris, France, 75015
Actively Recruiting
27
Imbria Investigational Site
Saint-Herblain, France, 44800
Actively Recruiting
28
Imbria Investigational Site
Bad Oeynhausen, Germany, 32545
Actively Recruiting
29
Imbria Investigational Site
Göttingen, Germany, 37075
Actively Recruiting
30
Imbria Investigational Site
Heidelberg, Germany, 69120
Actively Recruiting
31
Imbria Investigational Site
Jena, Germany, 07747
Not Yet Recruiting
32
Imbria Investigational Site
Florence, Italy, 50139
Actively Recruiting
33
Imbria Investigational Site
Massa, Italy, 54100
Actively Recruiting
34
Imbria Investigational Site
Milan, Italy, 20131
Actively Recruiting
35
Imbria Investigational Site
Milan, Italy, 20146
Actively Recruiting
36
Imbria Investigational Site
Milan, Italy, 20162
Actively Recruiting
37
Imbria Investigational Site
Naples, Italy, 80131
Actively Recruiting
38
Imbria Investigational Site
Amsterdam-Zuidoost, Netherlands, 1105 AZ
Actively Recruiting
39
Imbria Investigational Site
Leiden, Netherlands, 2333ZC
Not Yet Recruiting
40
Imbria Investigational Site
Nijmegen, Netherlands, 6525 GA
Not Yet Recruiting
41
Imbria Investigational Site
Rotterdam, Netherlands, 3015 AA
Actively Recruiting
42
Imbria Investigational Site
Katowice, Poland, 40-555
Actively Recruiting
43
Imbria Investigational Site
Warsaw, Poland, 02-507
Actively Recruiting
44
Imbria Investigational Site
Wroclaw, Poland, 53-114
Actively Recruiting
45
Imbria Investigational Site
Guimarães, Portugal, 4835-044
Actively Recruiting
46
Imbria Investigational Site
Lisbon, Portugal, 1169-024
Actively Recruiting
47
Imbria Investigational Site
Lisbon, Portugal, 1500-650
Actively Recruiting
48
Imbria Investigational Site
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
49
Imbria Investigational Site
A Coruña, Galicia, Spain, 15006
Actively Recruiting
50
Imbria Investigational Site
Madrid, Madrid, Spain, 28034
Actively Recruiting
51
Imbria Investigational Site
Vigo, Pontevedra, Spain, 36312
Actively Recruiting
52
Imbria Investigational Site
Seville, Sevilla, Spain, 41009
Actively Recruiting
53
Imbria Investigational Site
Seville, Sevilla, Spain, 41013
Actively Recruiting
54
Imbria Investigational Site
Barcelona, Spain, 8036
Actively Recruiting
55
Imbria Investigational Site
Barcelona, Spain, 8041
Actively Recruiting
56
Imbria Investigational Site
Barcelona, Spain, 8907
Actively Recruiting
57
Imbria Investigational Site
El Palmar, Spain, 30120
Actively Recruiting
58
Imbria Investigational Site
Madrid, Spain, 28222
Actively Recruiting
59
Imbria Investigational Site
Palma de Mallorca, Spain, 07198
Actively Recruiting
60
Imbria Investigational Site
Salamanca, Spain, 37007
Actively Recruiting
61
Imbria Investigational Site
Valencia, Spain, 03010
Actively Recruiting
62
Imbria Investigational Site
Valencia, Spain, 46026
Actively Recruiting
63
Imbria Investigational Site
London, England, United Kingdom, W12 0HS
Actively Recruiting
64
Imbria Investigational Site
Glasgow, Scotland, United Kingdom, G51 4TF
Actively Recruiting
65
Imbria Investigational Site
London, United Kingdom, EC1A 7BE
Actively Recruiting
66
Imbria Investigational Site
London, United Kingdom, SW3 6HP
Actively Recruiting
67
Imbria Investigational Site
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
M
Medical Monitor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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