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

Imbria Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Non-obstructive Hypertrophic Cardiomyopathy

Treatments: Drug: Placebo; Drug: IMB-1018972

Study type: Interventional

Funder types: Industry

Identifiers

NCT04826185

IMB101-007

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

IMB-1018972 200mg

Experimental group

Treatment:

Drug: IMB-1018972

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo