Clinical trial NCT04826185: A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Imbria Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, and potential efficacy of IMB-1018972 in patients with non-obstructive HCM.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Hypertrophic Cardiomyopathy consistent with current US and European guidelines
* Ability to perform an upright treadmill cardiopulmonary exercise test
* Agreement to abide by contraceptive requirements

Exclusion Criteria:

* Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability
* Women who are pregnant, planning to become pregnant or lactating
* Participation in another clinical study involving a test product or invasive medical device within 28 days (or within 5 elimination half-lives of the respective test product, whichever is longer), prior to first dosing

Primary outcomes:
measure: Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs
timeFrame: Baseline through Week 14 Safety Follow-up
Secondary outcomes:
measure: Change from baseline of peak oxygen consumption (VO2) and Oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Imbria Investigational Site
state: California
city: Los Angeles
country: United States
facility: Imbria Investigational Site
state: California
city: San Francisco
country: United States
facility: Imbria Investigational Site
state: California
city: Chicago
country: United States
facility: Imbria Investigational Site
state: Illinois
city: Boston
country: United States
facility: Imbria Investigational Site
state: Massachusetts
city: Burlington
country: United States
facility: Imbria Investigational Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Imbria Investigational Site
state: Missouri
city: Morristown
country: United States
facility: Imbria Investigational Site
state: New Jersey
city: New York
country: United States
facility: Imbria Investigational Site
state: New York
city: Charlotte
country: United States
facility: Imbria Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Imbria Investigational Site
state: Oregon
city: Houston
country: United States
facility: Imbria Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Imbria Investigational Site
state: Utah
city: Oxford
country: United Kingdom
facility: Imbria Investigational Site
Study officials:
affiliation: Imbria Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_CHAIR
References: