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IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)

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ClinicalTrials.gov Identifier: NCT04826159
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : January 11, 2023
Sponsor:
Collaborator:
University of Oxford
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 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 HFpEF - Heart Failure With Preserved Ejection Fraction Drug: IMB-1018972 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Change in cardiac PCr/ATP ratio at rest (Stage 1 and Stage 2) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972. [ Time Frame: Baseline, End of Treatment (up to 16 weeks) ]
  2. Change in cardiac PCr/ATP ratio with dobutamine stress (Stage 1 only) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972 [ 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 16 weeks) ]

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 type 2 diabetes
  • Elevated HbA1c
  • Elevated BMI
  • Preserved left ventricular ejection fraction
  • Diagnosis of HFpEF (Stage 2 only)

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
  • Inability to exercise (Stage 2 only)
  • 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
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): NCT04826159


Contacts
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Contact: Medical Monitor +1(617) 675-4060 info@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    info@imbria.com   
Sponsors and Collaborators
Imbria Pharmaceuticals, Inc.
University of Oxford
Investigators
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Study Director: Paul Chamberlin, MD Imbria Pharmaceuticals, Inc.
More Information
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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: January 11, 2023
Last Verified: January 2023
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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Diabetes Complications