A Randomized, Double-blind, Placebo-controlled, Multicenter, 24 Months Treatment Duration, Dose Finding Study, to Evaluate Efficacy, Safety and Pharmacodynamics of IBI3016 in Mild to Moderate Hypertensive Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Change in SBP by OBPM
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of IBI3016 or placebo, given subcutaneously, every 3 or 6 months, at different dose levels in patients with mild to moderate hypertension
详细描述
Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of IBI3016 in patients with mild to moderate hypertension. Multiple doses of IBI3016 will be tested against placebo, administered as subcutaneous injection.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Males or females aged 18 to 75 years.
- •Diagnosis of primary hypertension without anti-HTN medication or with one anti-HTN medication
- •Mean sitting SBP ≥140 mmHg and < 170 mmHg measured by OBPM.
- •Participants able to understand and comply with study procedures.
排除标准
- •Known history of secondary hypertension.
- •Orthostatic hypotension.
- •Laboratory parameter assessments outside of range at screening：
- •Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 2× Upper Limit of Normal (ULN)
- •Total Bilirubin > 1.5× ULN
- •International Normalized Ratio (INR) > 2.0
- •Serum Potassium > 5 mg/L
- •Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL/min/1.73m²
- •QTcF > 480 ms
- •Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
- •Current or history of intolerance to ACEi and/or ARBs.
- •Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening. Any history of congestive heart failure.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
placebo
subcutaneous injection
干预措施: Placebo (Other)
IBI3016 dose 4
subcutaneous injection
干预措施: IBI3016 (Drug)
IBI3016 dose 1
subcutaneous injection
干预措施: IBI3016 (Drug)
IBI3016 dose 2
subcutaneous injection
干预措施: IBI3016 (Drug)
IBI3016 dose 3
subcutaneous injection
干预措施: IBI3016 (Drug)
IBI3016 dose 5
subcutaneous injection
干预措施: IBI3016 (Drug)
结局指标
主要结局
Change in SBP by OBPM
时间窗: From baseline through month 3
Change from baseline at Month 3 in systolic blood pressure (SBP) by office blood pressure measurement (OBPM)
次要结局
- Change in Mean 24hr SBP by ABPM(From baseline through month 3)
- Change in SBP and DBP by OBPM(From baseline through month 6)
- Change in Mean 24hr, mean daytime, mean nighttime SBP and DBP by ABPM(Change from baseline through month 6 in Mean 24hr, mean daytime, mean nighttime SBP and DBP by OBPM)
- Percentage Change in AGT by blood test(From baseline through month 24)