Type 2 Diabetes Clinical Trial
Official title:
A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.
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
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oxford University Hospital | Oxford |
Lead Sponsor | Collaborator |
---|---|
Imbria Pharmaceuticals, Inc. | University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | ||
Primary | 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 | 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) |
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