| Trial ID: | L5503 |
| Source ID: | NCT04826159
|
| Associated Drug: |
Imb-1018972
|
| Title: |
IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes|Diabetic Cardiomyopathies|HFpEF - Heart Failure With Preserved Ejection Fraction
|
| Interventions: |
DRUG: IMB-1018972
|
| Outcome Measures: |
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)|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)
|
| Sponsor/Collaborators: |
Sponsor: Imbria Pharmaceuticals, Inc. | Collaborators: University of Oxford
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-04-21
|
| Completion Date: |
2024-03
|
| Results First Posted: |
|
| Last Update Posted: |
2023-01-11
|
| Locations: |
Oxford University Hospital, Oxford, OX3 9DU, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT04826159
|
