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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2023-09-18

Brief Summary

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

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Detailed Description

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Conditions

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Non-obstructive Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IMB-1018972 200mg

Group Type EXPERIMENTAL

IMB-1018972

Intervention Type DRUG

Modified release (MR) oral tablet

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching oral tablet

Interventions

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IMB-1018972

Modified release (MR) oral tablet

Intervention Type DRUG

Placebo

Matching oral tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No