NCT04826159CompletedPhase 2
A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.
Imbria Pharmaceuticals, Inc.1 site in 1 country49 target enrollmentStarted: April 21, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Imbria Pharmaceuticals, Inc.
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IMB-1018972 200 mg
Experimental
Intervention: IMB-1018972 (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 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.
Time Frame: Baseline, End of Treatment (up to 16 weeks)
Secondary Outcomes
- 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))
Investigators
Study Sites (1)
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