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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04826185
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-obstructive Hypertrophic Cardiomyopathy Drug: IMB-1018972 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022


Arm Intervention/treatment
Experimental: IMB-1018972 200mg Drug: IMB-1018972
Modified release (MR) oral tablet

Placebo Comparator: Placebo Drug: Placebo
Matching oral tablet




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826185


Contacts
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Contact: Karen Jauregui (617) 675-4060 kj@imbria.com

Locations
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United States, California
Imbria Investigational Site
San Francisco, California, United States, 94143
Contact: Study Coordinator    415-353-9156      
United States, Massachusetts
Imbria Investigational Site
Boston, Massachusetts, United States, 02111
Contact: Study Coordinator    617-636-8066      
United States, North Carolina
Imbria Investigational Site
Charlotte, North Carolina, United States, 28203
Contact: Study Coordinator    704-373-0212      
United States, Oregon
Imbria Investigational Site
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-494-7400      
United Kingdom
Imbria Investigational Site
Oxford, United Kingdom
Contact: Study Coordinator    +44 (0) 1865 2 34588      
Sponsors and Collaborators
Imbria Pharmaceuticals, Inc.
Investigators
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Study Director: Paul Chamberlin, MD Imbria Pharmaceuticals, Inc.
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Responsible Party: Imbria Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04826185    
Other Study ID Numbers: IMB101-007
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases