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

Phase 2

Completed

• Conditions: Non-obstructive Hypertrophic Cardiomyopathy
• Interventions: Drug: IMB-1018972; Drug: Placebo

• Registration Number: NCT04826185
• Lead Sponsor: Imbria Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-06-14
• Primary Completion: 2023-09-18
• Study Completion: 2023-09-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMB-1018972 200mg	IMB-1018972	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Imbria Investigational Site; 🇬🇧 Oxford, United Kingdom