NCT04826185

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2021

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2023

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

March 18, 2021

Last Update Submit

April 22, 2024

Conditions

Non-obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (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

    Baseline through Week 14 Safety Follow-up

Secondary Outcomes (1)

  • Change from baseline of peak oxygen consumption (VO2) and Oxygen uptake efficiency slope (OUES), measured by standardized cardiopulmonary exercise testing (CPET)

    Baseline, Week 12

Study Arms (2)

IMB-1018972 200mg

EXPERIMENTAL
Drug: IMB-1018972

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IMB-1018972DRUG

Modified release (MR) oral tablet

IMB-1018972 200mg
PlaceboDRUG

Matching oral tablet

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Imbria Investigational Site

La Jolla, California, 92093, United States

Location

Imbria Investigational Site

Los Angeles, California, 90048, United States

Location

Imbria Investigational Site

San Francisco, California, 94143, United States

Location

Imbria Investigational Site

Chicago, Illinois, 60611, United States

Location

Imbria Investigational Site

Boston, Massachusetts, 02111, United States

Location

Imbria Investigational Site

Burlington, Massachusetts, 01805, United States

Location

Imbria Investigational Site

St Louis, Missouri, 63110, United States

Location

Imbria Investigational Site

Morristown, New Jersey, 07960, United States

Location

Imbria Investigational Site

New York, New York, 10016, United States

Location

Imbria Investigational Site

Charlotte, North Carolina, 28203, United States

Location

Imbria Investigational Site

Portland, Oregon, 97239, United States

Location

Imbria Investigational Site

Houston, Texas, 77030, United States

Location

Imbria Investigational Site

Salt Lake City, Utah, 84112, United States

Location

Imbria Investigational Site

Oxford, United Kingdom

Location

Study Officials

  • Medical Monitor

    Imbria Pharmaceuticals, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2021

First Posted

April 1, 2021

Study Start

June 14, 2021

Primary Completion

September 18, 2023

Study Completion

September 18, 2023

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

US(13)GB(1)