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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)

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ClinicalTrials.gov Identifier: NCT04826185
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : October 13, 2022
Sponsor:
Information provided by (Responsible Party):
Imbria Pharmaceuticals, Inc.

Study Description
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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

Study Design
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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
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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Arm Intervention/treatment
Experimental: IMB-1018972 200mg Drug: IMB-1018972
Modified release (MR) oral tablet
Placebo Comparator: Placebo Drug: Placebo
Matching oral tablet


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 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
Contacts and Locations
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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: Medical Monitor +1(617) 675-4060 info@imbria.com

Locations
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United States, California
Imbria Investigational Site Not yet recruiting
La Jolla, California, United States, 92093
Contact: Study Coordinator         
Imbria Investigational Site Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Study Coordinator         
Imbria Investigational Site Recruiting
San Francisco, California, United States, 94143
Contact: Study Coordinator    415-502-5072    info@imbria.com   
United States, Illinois
Imbria Investigational Site Recruiting
Chicago, Illinois, United States, 60611
Contact: Study Coordinator    312-926-8629    info@imbria.com   
United States, Massachusetts
Imbria Investigational Site Completed
Boston, Massachusetts, United States, 02111
Imbria Investigational Site Not yet recruiting
Burlington, Massachusetts, United States, 01805
Contact: Study Coordinator         
United States, Missouri
Imbria Investigational Site Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-707-7559    info@imbria.com   
United States, New Jersey
Imbria Investigational Site Not yet recruiting
Morristown, New Jersey, United States, 07960
Contact: Study Coordinator         
United States, New York
Imbria Investigational Site Recruiting
New York, New York, United States, 10016
Contact: Study Coordinator    646-831-6588    info@imbria.com   
United States, North Carolina
Imbria Investigational Site Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Study Coordinator    704-355-4796    info@imbria.com   
United States, Oregon
Imbria Investigational Site Recruiting
Portland, Oregon, United States, 97239
Contact: Study Coordinator    503-494-7113    info@imbria.com   
United States, Texas
Imbria Investigational Site Not yet recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator         
United States, Utah
Imbria Investigational Site Not yet recruiting
Salt Lake City, Utah, United States, 84112
Contact: Study Coordinator         
United Kingdom
Imbria Investigational Site Recruiting
Oxford, United Kingdom
Contact: Study Coordinator    +44 (1) 865521172    info@imbria.com   
Sponsors and Collaborators
Imbria Pharmaceuticals, Inc.
Investigators
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Study Chair: Medical Monitor Imbria Pharmaceuticals, Inc.
More Information
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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: October 13, 2022
Last Verified: October 2022
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
Aortic Valve Disease
Heart Valve Diseases