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

Imbria Pharmaceuticals, Inc.49 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

IMB-1018972DRUG

Modified release tablet for oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Oxford University Hospital

Oxford, United Kingdom

Outcomes

Primary Outcomes

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)

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 Outcomes

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)

Data from ClinicalTrials.gov

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