CompletedPhase 2

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

United Kingdom49 participantsStarted 2021-04-21

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 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

Timeframe: Baseline, End of Treatment (up to 8 weeks)

Trial details

NCT IDNCT04826159

SponsorImbria Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-06

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