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

April 22, 2024 updated by: Imbria Pharmaceuticals, Inc.

A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom
        • Imbria Investigational Site
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Imbria Investigational Site
      • Los Angeles, California, United States, 90048
        • Imbria Investigational Site
      • San Francisco, California, United States, 94143
        • Imbria Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Imbria Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Imbria Investigational Site
      • Burlington, Massachusetts, United States, 01805
        • Imbria Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Imbria Investigational Site
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Imbria Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Imbria Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Imbria Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Imbria Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Imbria Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Imbria Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching oral tablet
Experimental: IMB-1018972 200mg
Drug: IMB-1018972
Modified release (MR) oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Baseline through Week 14 Safety Follow-up
Baseline through Week 14 Safety Follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of peak oxygen consumption (VO2) and Oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET)
Time Frame: Baseline, Week 12
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imbria Pharmaceuticals, Inc.

Investigators

  • Study Chair: Medical Monitor, Imbria Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2021

Primary Completion (Actual)

September 18, 2023

Study Completion (Actual)

September 18, 2023

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMB101-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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