IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)
Study Details
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IMB-1018972 200 mg
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Drug: IMB-1018972
Modified release tablet for oral administration
|
Outcome Measures
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. [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 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 [Baseline through End of Treatment (up to 16 weeks)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of type 2 diabetes
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Elevated HbA1c
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Elevated BMI
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Preserved left ventricular ejection fraction
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Diagnosis of HFpEF (Stage 2 only)
Exclusion Criteria:
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Uncontrolled hypertension
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Contraindication to magnetic resonance scanning
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More than mild to moderate valvular heart disease
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Atrial fibrillation
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History of sustained ventricular tachycardia or cardiac arrest
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Inability to exercise (Stage 2 only)
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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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Oxford University Hospital | Oxford | United Kingdom | OX3 9DU |
Sponsors and Collaborators
- Imbria Pharmaceuticals, Inc.
- University of Oxford
Investigators
- Study Director: Paul Chamberlin, MD, Imbria Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMB101-005