NCT06833190终止2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Multiple Dose Regimen of REGN5381, an NPR1 Monoclonal Antibody Agonist, in Participants With Uncontrolled Hypertension
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Unattended Automated Office-Based Blood Pressure (AOBP) Systolic Blood Pressure (SBP)
研究概览
简要总结
This study is researching an experimental drug called REGN5381 (called "study drug"). The study is focused on uncontrolled hypertension (high blood pressure despite being on one or more antihypertensive drugs).
The aim of the study is to see how effective the study drug is in reducing blood pressure. The study is designed as a 2-part study with participants initially enrolling in Part A. Part B of the study will commence and enroll the remaining study participants.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
详细描述
As of October 15, 2025, this study has been terminated, and all future onsite visits have been canceled. However, participants have been asked to report safety information to the trial helpline until January 15, 2026.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with SBP ≥130 mm Hg and SBP ≤180 mm Hg at both screening and randomization visit, as described in the protocol
- •≥ 40 and ≤85 years on a stable regimen of ≥1 anti-hypertensive therapy for at least 1 month at the time of screening or ≥30 and <40 years on a stable regimen of ≥3 anti-hypertensive therapies for at least 1 month at the time of screening
- •Key Exclusion Criteria
- •Heart rate >100 bpm as described in the protocol
- •Body mass index >45 kg/m2 as described in the protocol
- •Glomerular filtration rate (GFR) <30 mL/min/1.73m2 at screening as described in the protocol
- •Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN) as described in the protocol
- •NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply
排除标准
- 未提供
研究组 & 干预措施
REGN5381 Low Dose
Experimental
Randomized as described in the protocol
干预措施: REGN5381 (Drug)
REGN5381 High Dose
Experimental
Randomized as described in the protocol
干预措施: REGN5381 (Drug)
Placebo
Placebo Comparator
Randomized as described in the protocol
干预措施: Placebo (Drug)
结局指标
主要结局
Unattended Automated Office-Based Blood Pressure (AOBP) Systolic Blood Pressure (SBP)
时间窗: At week 12
次要结局
- Unattended AOBP SBP in stage 3 Chronic Kidney Disease (CKD) participants(At week 12)
- Mean SBP by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)(At week 12)
- Concentrations of REGN5381 in serum(Through week 20)
- Unattended AOBP SBP in participants on ≥3 anti-hypertensive therapies(At week 12)
- AOBP SBP(From baseline to weeks 2, 4 and 8)
- Time-weighted average AOBP SBP(Through week 12)
- AOBP DBP(From baseline to weeks 2, 4, 8 and 12)
- Time-weighted average AOBP Diastolic Blood Pressure (DBP)(Through week 12)
- Titer of ADAs to REGN5381(Through week 20)
- Occurrence of Treatment Emergent Adverse Events (TEAEs)(Up to week 23)
- Severity of TEAEs(Up to week 23)
- Occurrence of TEAEs leading to discontinuation of study drug(Up to week 23)
- Occurrence of Anti-Drug Antibodies (ADAs) to REGN5381(Through week 20)
研究者
研究点 (3)
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