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

Phase 2 Completed 49 enrolled Imbria Pharmaceuticals, Inc. University of Oxford · collab

NaSingle-groupOpen-labelTreatment

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

Timeline

Start: 2021-04-21
Primary completion: 2024-08-06
Completion: 2024-08-06

Outcome

Met primary endpoint

release “consistent with an improvement in cardiac energy reserves and meeting the trial’s primary objective” imbria.com ↗

release “Treatment with ninerafaxstat resulted in a significant improvement in this ratio, meeting the trial’s primary endpoint” imbria.com ↗

Publications

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. 2026 Feb 24;153(8):550-563. doi: 10.1161/CIRCULATIONAHA.125.074041. Epub 2025 Dec 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ninerafaxstat	Small molecule	200 mg	Oral