Back to resultsA Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial (IMPROVE-HCM)
Primary Purpose
Non-obstructive Hypertrophic Cardiomyopathy
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IMB-1018972
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-obstructive Hypertrophic Cardiomyopathy
Eligibility 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
Sites / Locations
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
- Imbria Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IMB-1018972 200mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from baseline of peak oxygen consumption (VO2) and Oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET)
Full Information
NCT ID
NCT04826185
First Posted
March 18, 2021
Last Updated
June 15, 2023
Sponsor
Imbria Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04826185
Brief Title
A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial
Acronym
IMPROVE-HCM
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imbria Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-obstructive Hypertrophic Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMB-1018972 200mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IMB-1018972
Intervention Description
Modified release (MR) oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral tablet
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Imbria Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Imbria Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Imbria Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Imbria Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Imbria Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Imbria Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Imbria Investigational Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Imbria Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Imbria Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Imbria Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Imbria Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Imbria Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Imbria Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Imbria Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Imbria Investigational Site
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial
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