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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04826159
Other study ID # IMB101-005
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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)
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