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

Phase 2

Recruiting

• Conditions: Diabetic Cardiomyopathies; Type 2 Diabetes; HFpEF - Heart Failure With Preserved Ejection Fraction
• Interventions: Drug: IMB-1018972

• Registration Number: NCT04826159
• Lead Sponsor: Imbria Pharmaceuticals, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-04-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMB-1018972 200 mg	IMB-1018972	-

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Oxford University Hospital; 🇬🇧 Oxford, United Kingdom