Diabetic Cardiomyopathies, HFpEF - Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes
Conditions
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
Interventions
DRUGIMB-1018972
Modified release tablet for oral administration
Sponsors
University of Oxford
Imbria Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Baseline, End of Treatment (up to 16 weeks) |
| 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 | Baseline, End of Treatment (up to 8 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| 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 End of Treatment (up to 16 weeks) |
Countries
United Kingdom
Outcome results
None listed