NCT07123779招募中1 期
Phase 1b/2, Multicenter, Double-Blind, Placebo-Controlled, Multiple Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Obese Participants With Pulmonary Hypertension and HFpEF
35Pharma Inc1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Incidence and Number of Adverse Events (AEs)
研究概览
简要总结
Study of HS235 in Obese Participants with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction
详细描述
A Phase 1b/2, Multicenter, Double-Blind, Placebo-Controlled, Multiple Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Obese Participants with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Participants are eligible to be included in the study only if they meet at least all the following criteria:
- •Male or female, ≥ 18 years of age.
- •[Sub-population A only - using a remote PAP sensor]- Ambulatory PAP monitoring (e.g., CardioMEMS™ HF System or Cordella™ HF System) implanted in the course of standard of care at least 90 days before Screening.
- •Hemodynamic evidence of PH with:
- •mPAP ≥ 25 mm Hg, as measured in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization AND,
- •dPAP ≥ 15 mm Hg, as measured in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization.
- •[Sub-population B only - without a remote PAP sensor]
- •Hemodynamic evidence of PH based on the presence of all the following RHC parameters obtained during the Screening period, prior to randomization:
- •PVR ≥ 240 dyn*sec/cm5 or ≥ 3 WU, and
- •mPAP > 20 mmHg, and
- •PAWP > 15 mmHg but < 30 mmHg, and
- •dPAP ≥ 15 mmHg.
- •Established diagnosis of HFpEF with left ventricular ejection fraction (LVEF) ≥ 45 % as measured by echocardiography during Screening and and no documented LVEF < 45% during the 2 years preceding Screening..
- •New York Heart Association (NYHA) class II or III heart failure symptoms.
- •Stable diuretic regimen during the screening period.
- •Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) < 90 at screening.
- •6-minute walking distance (6MWD) ≥ 100 m at screening.
- •Body mass index ≥ 30 to ≤ 50 kg/m2 and Body weight ≤140 kg.
- •Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
排除标准
- •Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
- •Occurrence of an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 90 days prior to Screening.
- •Implantation of a cardiac resynchronization therapy (CRT) device within 90 days before screening.
- •Planned cardiovascular revascularization or planned implantation of CRT device.
- •History of heart transplant or on heart transplant list.
- •History of serious or life-threatening cardiac arrhythmia within 90 days prior to screening.
- •Systemic hypotension or uncontrolled systemic hypertension.
- •History of Pericardial constriction or hypertrophic cardiomyopathy.
- •History of significant valvular stenosis or regurgitation.
- •Participants with a pneumonectomy or more than moderate Chronic Obstructive Pulmonary Disease (COPD) or mild interstitial lung disease (ILD) or mild obstructive sleep apnea (OSA).
研究组 & 干预措施
Placebo
Placebo Comparator
Subcutaneous Injection
干预措施: Placebo (Other)
Investigational Product
Experimental
HS235 Subcutaneous Injection
干预措施: HS235 (Biological)
结局指标
主要结局
Incidence and Number of Adverse Events (AEs)
时间窗: Up to 24 weeks
An AE is any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of participants who experience an AE will be reported.
次要结局
未报告次要终点
研究者
研究点 (1)
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