Key result
Ninerafaxstat improves myocardial energetics and NYHA functional class in obese patients with type 2 diabetes.
Why the study?
To evaluate the safety and effectiveness of ninerafaxstat, a novel therapeutic designed to enhance cardiac energetics, in patients with cardiometabolic syndromes.
Does ninerafaxstat improve myocardial energetics and symptom burden in patients with type 2 diabetes and obesity, with or without HFpEF?
Does ninerafaxstat improve myocardial energetics and symptom burden in patients with type 2 diabetes and obesity, with or without HFpEF?
Answers are grounded in this paper and cite their sources.
Ninerafaxstat is safely tolerated and improves myocardial energetics and symptom burden in patients with obesity and diabetes, with or without HFpEF.
BACKGROUND: We report IMPROVE-DiCE (Improve Diabetic Cardiac Energetics), a 2-part open-label, phase 2a trial evaluating the safety and effectiveness of ninerafaxstat, a novel therapeutic designed to enhance cardiac energetics. Between May and September 2021, part 1 enrolled patients with type 2 diabetes and obesity without heart failure with preserved ejection fraction (HFpEF). Between January 2023 and June 2024, part 2 enrolled patients with type 2 diabetes, obesity, and HFpEF. METHODS: C]pyruvate magnetic resonance spectroscopy to assess in vivo pyruvate dehydrogenase flux (n=9) and plasma metabolomics and proteomics were also performed. CONCLUSIONS: These mechanistic phase 2a study results show that ninerafaxstat is safely tolerated and improves myocardial energetics in participants with obesity and diabetes without or with clinically manifest HFpEF. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04826159.
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Hundertmark et al. (2025) studied Cardiometabolic syndromes (type 2 diabetes and obesity with or without HFpEF). Ninerafaxstat was evaluated on Safety and myocardial energetics (p=0.02). Ninerafaxstat was safely tolerated, improved myocardial energetics (P=0.02), and reduced NYHA class symptom burden in patients with obesity and type 2 diabetes with or without HFpEF.
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