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Completed

NCT Number: NCT04826159

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

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

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Key information

Conditions

Type 2 Diabetes Cardiomyopathies Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Cardiomyopathies Endocrine System Diseases Glucose Metabolism Disorders HFpEF - Heart Failure With Preserved Ejection Fraction Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oxford University Hospital

Oxford, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMB-1018972

Drug

Modified release tablet for oral administration

Primary outcomes

  1. 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)

  2. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Imbria Pharmaceuticals, Inc.

Industry

Collaborators

  • University of Oxford

Registry information

Official study title

A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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