NCT04826159已完成2 期
A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes
- •Elevated HbA1c
- •Elevated BMI
- •Preserved left ventricular ejection fraction
- •Diagnosis of HFpEF (Stage 2 only)
排除标准
- •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
研究组 & 干预措施
IMB-1018972 200 mg
Experimental
干预措施: IMB-1018972 (Drug)
结局指标
主要结局
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
时间窗: Baseline, End of Treatment (up to 8 weeks)
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.
时间窗: Baseline, End of Treatment (up to 16 weeks)
次要结局
- 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))
研究者
研究点 (1)
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