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Trial record 3 of 3 for:    IMB-101

A Study to Evaluate the Effect of IMB-1018972 on Cardiac Energetics in Patients With Type 2 Diabetes (IMPROVE-DiCE)

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ClinicalTrials.gov Identifier: NCT04826159
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Imbria Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to assess the activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Diabetic Cardiomyopathies Drug: IMB-1018972 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IMB-1018972 200 mg Drug: IMB-1018972
Modified release tablet for oral administration




Primary Outcome Measures :
  1. Change in cardiac PCr/ATP ratio with dobutamine stress (ie, dobutamine stress-induced drop in PCr/ATP ratio from its resting value at the same time point) measured by 31P-MRS [ Time Frame: Baseline, End of Treatment (up to 8 weeks) ]

Secondary 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 End of Treatment (up to 8 weeks) ]


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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 type 2 diabetes
  • Elevated HbA1c
  • Elevated BMI
  • Preserved left ventricular ejection fraction

Exclusion Criteria:

  • Uncontrolled hypertension
  • Contraindication to magnetic resonance scanning
  • More than mild to moderate valvular heart disease
  • Atrial fibrillation
  • History of sustained ventricular tachycardia or cardiac arrest
  • 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

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): NCT04826159


Contacts
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Contact: Karen Jauregui 6176754060 DiCE_ClinicalTrial@Imbria.com

Locations
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United Kingdom
Oxford University Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Study Coordinator    +44 (0)1865 2 2527987    DiCE_ClinicalTrial@Imbria.com   
Sponsors and Collaborators
Imbria Pharmaceuticals, Inc.
University of Oxford
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: NCT04826159    
Other Study ID Numbers: IMB101-005
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cardiomyopathies
Diabetic Cardiomyopathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Diabetes Complications