NCT07795814招募中2 期
A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 25
- 主要终点
- Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is a Phase 2 placebo-controlled study to evaluate the safety and tolerability of different doses of EDG-15400 in adults with heart failure with preserved ejection fraction (HFpEF).
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)
入排标准
- 年龄范围
- 30 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and nonpregnant females, ages ≥30 to <85 years of age at screening
- •Body weight ≥ 45 kg, BMI < 40
- •LVEF ≥ 50%
- •Diagnosed with Heart Failure per American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines for the Management of Heart Failure
- •New York Heart Association (NYHA) functional class II or III
- •If receiving Guideline-directed Medical Therapy, must be on stable doses
- •Participants receiving a GLP-1 agonist prior to Screening must have no anticipated plans to change dose during the study
排除标准
- •Known diagnosis of hypertrophic cardiomyopathy (HCM)
- •Known or suspected infiltrative or storage disorder (e.g., Noonan syndrome, Fabry disease, amyloidosis)
- •Moderate or greater interstitial lung disease (ILD) or ILD requiring chronic supplemental O2 therapy
- •Severe or greater chronic obstructive pulmonary disease (COPD) or COPD requiring chronic supplementary O2 therapy
- •Hospitalization for any reason within 60 days prior to Screening
- •History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Investigator or the Medical Monitor, would be an alternative explanation for heart failure symptoms (e.g., significant lung disease, anemia) and/or would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion
研究组 & 干预措施
EDG-15400 25 mg
Experimental
干预措施: EDG-15400 25 mg (Drug)
EDG-15400 50 mg
Experimental
干预措施: EDG-15400 50 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo to match EDG-15400 25 mg or 50 mg (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: From baseline through study completion (up to 20 weeks)
Incidence of TEAEs and SAEs observed during dosing of EDG-15400 in patients with HFpEF
次要结局
- Change in Biomarkers(From baseline through study completion (up to 20 weeks))
- EDG-15400 Plasma Concentrations(From baseline through study completion (up to 20 weeks))
研究者
研究点 (25)
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