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

Sponsor
Imbria Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04826159
Collaborator
University of Oxford (Other)
50
1
1
34.3
1.5

Study Details

Study Description

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
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.
Actual Study Start Date :
Apr 21, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: IMB-1018972 200 mg

Drug: IMB-1018972
Modified release tablet for oral administration

Outcome Measures

Primary Outcome Measures

  1. 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)]

  2. 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 Outcome Measures

  1. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oxford University Hospital Oxford United Kingdom OX3 9DU

Sponsors and Collaborators

  • Imbria Pharmaceuticals, Inc.
  • University of Oxford

Investigators

  • Study Director: Paul Chamberlin, MD, Imbria Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imbria Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT04826159
Other Study ID Numbers:
  • IMB101-005
First Posted:
Apr 1, 2021
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022