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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826159
• Other study ID #: IMB101-005
• Status: Recruiting
• Phase: Phase 2
• Start date: April 21, 2021
• Est. completion date: March 2024

Study information

• Verified date: January 2023
• Source: Imbria Pharmaceuticals, Inc.
• Contact: Medical Monitor
• Phone: +1(617) 675-4060
• Email: info[@]imbria.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetes Mellitus, Type 2
• Diabetic Cardiomyopathies
• Type 2 Diabetes

Intervention

Drug:
• IMB-1018972
Modified release tablet for oral administration

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Imbria Pharmaceuticals, Inc.	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Secondary	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)