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CompletedNCT04826185IMPROVE-HCMUpdated Apr 23, 2024

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

A Phase 2 interventional study of IMB-1018972 and Placebo in Non-obstructive Hypertrophic Cardiomyopathy, sponsored by Imbria Pharmaceuticals, Inc.. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Imbria Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2023, 3 years ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Non-obstructive Hypertrophic Cardiomyopathy
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 67 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Imbria Pharmaceuticals, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    IMB-1018972 200mg

    Drug: IMB-1018972

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugIMB-1018972

    Modified release (MR) oral tablet

  • DrugPlacebo

    Matching oral tablet

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

14 sites
  • Imbria Investigational Site
    La Jolla, California 92093, United States
  • Imbria Investigational Site
    Los Angeles, California 90048, United States
  • Imbria Investigational Site
    San Francisco, California 94143, United States
  • Imbria Investigational Site
    Chicago, Illinois 60611, United States
  • Imbria Investigational Site
    Boston, Massachusetts 02111, United States
  • Imbria Investigational Site
    Burlington, Massachusetts 01805, United States
  • Imbria Investigational Site
    Saint Louis, Missouri 63110, United States
  • Imbria Investigational Site
    Morristown, New Jersey 07960, United States
  • Imbria Investigational Site
    New York, New York 10016, United States
  • Imbria Investigational Site
    Charlotte, North Carolina 28203, United States
  • Imbria Investigational Site
    Portland, Oregon 97239, United States
  • Imbria Investigational Site
    Houston, Texas 77030, United States
  • Imbria Investigational Site
    Salt Lake City, Utah 84112, United States
  • Imbria Investigational Site
    Oxford, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04826185
Lead sponsor
Imbria Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Jun 14, 2021
Primary completion
Sep 18, 2023
Completion
Sep 18, 2023
Last update
Apr 23, 2024

Study contacts

Medical Monitor
study chair · Imbria Pharmaceuticals, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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