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

Imbria Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Cardiomyopathies; Type 2 Diabetes; HFpEF - Heart Failure With Preserved Ejection Fraction

Treatments: Drug: IMB-1018972

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04826159

IMB101-005

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

IMB-1018972 200 mg

Experimental group

Treatment:

Drug: IMB-1018972