NCT06639087终止1 期
Phase Ib Randomised, Placebo-controlled, Double-blind, Multicentre Study to Assess the Effects and Safety of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in sodium excretion
研究概览
简要总结
A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.
详细描述
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate the safety, pharmacodynamics, and pharmacokinetics of AZD5462 on top of dapagliflozin in participants with heart failure and renal impairment.
The study will include 5 periods and approximately 9 study site visits:
- Screening Period of up to 4 weeks (at least one study visit)
- Run-in Period of up to 4 weeks (one study visit)
- Inpatient Treatment Period of 4 days (one study visit)
- Outpatient Treatment Period of up to 4 weeks (three study visits)
- Follow-up Period of up to 4 weeks (three study visits)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a pre-existing diagnosis of heart failure (HF).
- •Participants must have a left ventricular ejection fraction (LVEF) of ≤ 40% based on echocardiography taken within the last 9 months.
- •Participants must have an estimated glomerular filtration rate (eGFR) of 30 to 60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m2) (inclusive) at Screening as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 (creatinine) equation.
- •Participants must be on stable HF standard of care (SoC) medication for at least 4 weeks prior to Screening. If the participant is currently taking diuretics, then diuretics must also be stable for at least one week prior to Screening.
- •Participants must be on stable Sodium-glucose co-transporter-2 inhibitors (SGLT2) inhibitor treatment for at least 12 weeks prior to Screening.
- •Minimum BMI of 18 kilograms per meter squared (kg/m2) at Screening.
排除标准
- •Historical or current evidence of a clinically significant disease or disorder.
- •Participants with a known hypersensitivity to AZD5462 or dapagliflozin, or to any of the excipients of these drug products.
- •Congenital long QT syndrome or history of QT prolongation associated with other medications that required discontinuation of that medication.
- •Cardiac ventricular arrhythmia that requires treatment. However, participants with atrial fibrillation or flutter and controlled ventricular rate (eg, resting heart rate < 110 beats per minute) are permitted. Participants with cardiac ventricular arrhythmia that are treated with antiarrhythmic agents (eg, amiodarone) and are stable are permitted.
- •History of or anticipated heart transplant.
- •Any planned highly invasive cardiovascular procedure (eg, coronary revascularisation, valve repair/replacement, aortic aneurysm surgery).
- •Any evidence of clinically important disease or disorder which in the Investigator's opinion makes it undesirable for the participant to participate in the study.
- •Positive hepatitis C antibody, hepatitis B virus surface antigen, or hepatitis B virus core antibody at Screening.
研究组 & 干预措施
AZD5462 + dapagliflozin
Active Comparator
Participants will receive AZD5462 on top of dapagliflozin once daily.
干预措施: AZD5462 (Drug)
AZD5462 + dapagliflozin
Active Comparator
Participants will receive AZD5462 on top of dapagliflozin once daily.
干预措施: Dapagliflozin (Drug)
Placebo + dapagliflozin
Placebo Comparator
Participants will receive placebo on top of dapagliflozin once daily.
干预措施: Dapagliflozin (Drug)
Placebo + dapagliflozin
Placebo Comparator
Participants will receive placebo on top of dapagliflozin once daily.
干预措施: Placebo (Other)
结局指标
主要结局
Change in sodium excretion
时间窗: From Baseline to Day 1
To evaluate the effect of AZD5462 on top of dapagliflozin in participants with heart failure (HF) and renal impairment.
次要结局
- Change in urine albumin-creatinine ratio (uACR)(From Baseline to Day 1 and 29)
- Change in haematocrit(From Baseline to Day 29)
- Number of adverse events (AEs) and Serious Adverse Events (SAEs)(From Baseline to Day 57)
研究者
研究点 (1)
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