Back to resultsIMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)
Primary Purpose
Type 2 Diabetes, Diabetic Cardiomyopathies, HFpEF - Heart Failure With Preserved Ejection Fraction
Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
IMB-1018972
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility 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
Sites / Locations
- Oxford University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMB-1018972 200 mg
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Secondary 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
Full Information
NCT ID
NCT04826159
First Posted
March 18, 2021
Last Updated
January 9, 2023
Sponsor
Imbria Pharmaceuticals, Inc.
Collaborators
University of Oxford
1. Study Identification
Unique Protocol Identification Number
NCT04826159
Brief Title
IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)
Official Title
A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imbria Pharmaceuticals, Inc.
Collaborators
University of Oxford
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Diabetic Cardiomyopathies, HFpEF - Heart Failure With Preserved Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMB-1018972 200 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IMB-1018972
Intervention Description
Modified release tablet for oral administration
Primary Outcome Measure Information:
Title
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)
Title
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 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 End of Treatment (up to 16 weeks)
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Monitor
Phone
+1(617) 675-4060
Email
info@imbria.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Chamberlin, MD
Organizational Affiliation
Imbria Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Oxford University Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 (0)1865 2 2527987
Email
info@imbria.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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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