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

NCT04826159 | Completed Phase 2 FDA Drug

• 1 other identifier: IMB101-005
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes; Diabetic Cardiomyopathies; HFpEF - Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (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)

Study Arms (1)

IMB-1018972 200 mg

EXPERIMENTAL

Drug: IMB-1018972

Interventions

IMB-1018972 DRUG

Modified release tablet for oral administration

IMB-1018972 200 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes
• Elevated HbA1c
• Elevated BMI
• Preserved left ventricular ejection fraction
• Diagnosis of HFpEF (Stage 2 only)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imbria Pharmaceuticals, Inc.: lead
• University of Oxford: collaborator

Study Sites (1)

Oxford University Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• Hundertmark MJ, Birkhoelzer SM, Portwood C, Siu AG, Matthews V, Lewis AJ, Grist J, Mozes F, Henry JA, Patel J, Chamberlin P, Sarwar R, Yavari A, Dehbi HM, Rao P, Shi X, Zheng S, Robbins JM, Gerszten RE, Frenneaux MP, Valkovic L, Miller JJJJ, Neubauer S, Tyler DJ, Rider OJ. IMPROVE-DiCE, a 2-Part, Open-Label, Phase 2a Trial Evaluating the Safety and Effectiveness of Ninerafaxstat in Patients With Cardiometabolic Syndromes. Circulation. 2025 Dec 18. doi: 10.1161/CIRCULATIONAHA.125.074041. Online ahead of print.

  PMID: 41410037 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Diabetes Complications

Study Officials

• Arash Yavari, BSc, MBBS, DPhil

  Imbria Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 1, 2021
• Study Start: April 21, 2021
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

GB (1)