NCT07761117招募中3 期
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 6,950
- 试验地点
- 672
- 主要终点
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit
研究概览
简要总结
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left ventricular ejection fraction (LVEF) of > 40% within 12 months prior to screening.
- •Structural heart disease evidence.
- •HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening.
排除标准
- •BMI <25 kg/m² at screening.
- •Diabetes exclusions:
- •History of type 1 diabetes.
- •HbA1c ≥10% at screening.
- •Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema.
- •more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition.
- •Renal exclusions:
- •On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening
- •Cardiovascular exclusions:
- •Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization.
- •Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia.
- •GI exclusions:
- •Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery.
- •History of acute or chronic pancreatitis.
- •Endocrine exclusions:
- •History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.
研究组 & 干预措施
Elecoglipron
Experimental
Elecoglipron tablet once daily
干预措施: Elecoglipron (Drug)
Placebo
Active Comparator
Placebo matching Elecoglipron tablet once daily
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit
时间窗: Up to 42 months
Time to first event of the composite of: * CV death * HHF * Urgent HF visit
次要结局
- To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)(Up to 42 months)
- To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke(Up to 42 months)
- To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.(Baseline and 52 weeks)
研究者
研究点 (672)
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