IMPROVE- DiCE是一项2部分,开放的2a期试验,评估了ninerafaxstat在心脏代谢综合征患者中的安全性和有效性
Moritz J Hundertmark1,2, Sarah M Birkhoelzer1, Clara Portwood1
1Oxford Centre for Clinical Magnetic Resonance Research, Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom (M.J.H., S.M.B., C.P., A.G.S., A.J.L., J.G., F.M., J.A.H., L.V., S.N., D.J.T., O.J.R.).
Circulation
|December 18, 2025
概括
在患有2型糖尿病和肥胖症的患者中,Ninerafaxstat可以安全地改善心脏能量,无论是否存在心力衰竭与保留射出分数 (HFpEF). 这种新疗法可以提高心肌酸与ATP的比率和运动能力.
科学领域:
- 心脏病学
- 代谢疾病
- 药理学
背景情况:
- 在IMPROVE- DiCE试验中研究了ninerafaxstat,这是一种针对心脏能量的新疗法.
- 第1部分专注于2型糖尿病和肥胖患者,但没有HFpEF.
- 第2部分包括2型糖尿病,肥胖和有症状的HFpEF患者.
研究的目的:
- 评估ninerafaxstat在增强心脏能量方面的安全性和有效性.
- 评估ninerafaxstat对心肌脂与ATP比率 (PCr/ATP) 和功能的影响.
- 探索ninerafaxstat在糖尿病心肌病中的治疗潜力.
主要方法:
- 2a期,开放式,两部分研究,涉及42名参与者.
- 尼尼拉法斯塔特 (每天两次200毫克) 服用4至12周.
- 用于评估心肌能量和功能的磁共振成像和光谱.
主要成果:
- 在两组中,ninerafaxstat改善了PCr/ ATP (第1部分:P=0. 002;第2部分:P=0. 02).
- 在第1部分,心肌甘油降低了34% (P=0. 03).
- 在第2部分,ninerafaxstat改善了缩功能,运动能力和NYHA等级.
结论:
- 在糖尿病和肥胖患者中,Ninerafaxstat可安全耐受.
- 这种药物有效地改善了患有HFpEF或没有HFpEF的参与者的心肌能量.
- 尼尼拉法克斯塔特具有治疗糖尿病心脏并发症的潜力.
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