A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial

Non-obstructive Hypertrophic Cardiomyopathy Clinical Trial

— IMPROVE-HCM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04826185
• Other study ID #: IMB101-007
• Status: Completed
• Phase: Phase 2
• Start date: June 14, 2021
• Est. completion date: September 18, 2023

Study information

• Verified date: April 2024
• Source: Imbria Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy
• Non-obstructive Hypertrophic Cardiomyopathy

Intervention

Drug:
• IMB-1018972
Modified release (MR) oral tablet
• Placebo
Matching oral tablet

Locations

Country	Name	City	State
United Kingdom	Imbria Investigational Site	Oxford
United States	Imbria Investigational Site	Boston	Massachusetts
United States	Imbria Investigational Site	Burlington	Massachusetts
United States	Imbria Investigational Site	Charlotte	North Carolina
United States	Imbria Investigational Site	Chicago	Illinois
United States	Imbria Investigational Site	Houston	Texas
United States	Imbria Investigational Site	La Jolla	California
United States	Imbria Investigational Site	Los Angeles	California
United States	Imbria Investigational Site	Morristown	New Jersey
United States	Imbria Investigational Site	New York	New York
United States	Imbria Investigational Site	Portland	Oregon
United States	Imbria Investigational Site	Saint Louis	Missouri
United States	Imbria Investigational Site	Salt Lake City	Utah
United States	Imbria Investigational Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Imbria Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline through Week 14 Safety Follow-up
Secondary	Change from baseline of peak oxygen consumption (VO2) and Oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET)		Baseline, Week 12