NCT07469800招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Participants With Mild to Moderate Hypertension Complicated by Overweight/Obesity Who Have Not Received Antihypertensive Drug Treatment
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- To evaluate the effect of IBI362 on mean sitting systolic blood pressure (msSBP) compared with placebo at Week 16 of treatment.
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of IBI362 in participants with mild to moderate hypertension complicated by overweight/obesity who have not received antihypertensive drug treatment
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
- Double (Participant, Investigator)
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
- •Aged ≥ 18 years old at the time of signing the informed consent form.
- •Confirmed diagnosis of hypertension.
- •No prior history of antihypertensive medication treatment at screening; or previously received only one type of antihypertensive medication during the same period and has discontinued all antihypertensive medications for at least 2 weeks prior to screening.
- •Voluntarily sign the informed consent form and be willing to strictly comply with the requirements and restrictions stated in the informed consent form and the protocol throughout the study, including but not limited to: maintaining a stable diet and exercise routine, receiving the study drug injections as scheduled, and keeping a study diary.
排除标准
- •The investigator suspects that the participant may be allergic to the components of the study drug or drugs of the same class.
- •History of orthostatic hypotension, or blood pressure measured at screening meeting the criteria for orthostatic hypotension.
- •History or diagnostic evidence of secondary hypertension other than obstructive sleep apnea, including but not limited to: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), aortic stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
- •Concurrent use of beta-blockers within 1 month prior to screening.
- •Self-reported body weight change > 5 kg within 3 months.
- •History of acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), large artery aneurysm or dissecting aneurysm, transient ischemic attack (TIA), cerebrovascular accident, severe arrhythmia (e.g., ventricular fibrillation, ventricular flutter, atrial fibrillation, atrial flutter, second-degree or higher atrioventricular block, sick sinus syndrome, etc.) within 6 months; or history of decompensated heart failure or heart failure of New York Heart Association (NYHA) Class III or IV; or history of severe diseases such as epilepsy or syncope, which the investigator deems unsuitable for trial participation.
- •Confirmed diagnosis of diabetes mellitus, or laboratory tests showing glycated hemoglobin (HbA1c) ≥ 6.5%, fasting blood glucose ≥ 7 mmol/L and/or random blood glucose ≥ 11.1 mmol/L.
- •History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, acute cholangitis, or symptomatic/treated gallbladder disease (except for participants who have undergone cholecystectomy and are judged eligible by the investigator); or serum amylase or lipase > 2.0 × Upper Limit of Normal (ULN); or fasting serum triglycerides ≥ 5.64 mmol/L (500 mg/dl).
- •Chronic gastrointestinal diseases or systemic diseases that may affect gastrointestinal motility at screening, or use of drugs that may alter gastrointestinal motility, appetite or absorption within 3 months prior to screening.
- •History or relevant family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B.
研究组 & 干预措施
Placebo Control Group
Placebo Comparator
干预措施: Placebo (Drug)
IBI362 treatment Group
Experimental
干预措施: IBI362 (Drug)
结局指标
主要结局
To evaluate the effect of IBI362 on mean sitting systolic blood pressure (msSBP) compared with placebo at Week 16 of treatment.
时间窗: Week 16
Change from baseline in msSBP at trough (end-of-dosing interval) at Week 16
次要结局
- To evaluate the effect of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP) compared with placebo at Week 24 of treatment.(Week 24)
- To evaluate the effect of IBI362 on body weight compared with placebo at Weeks 16 and 24 of treatment.(Week 16 and Week 24)
- To evaluate the trough-to-peak ratio of the antihypertensive effect of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP)and Mean Sitting Diastolic Arterial Pressure（msDBP)at Week 16 of treatment.(Week 16)
- The effects of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP) compared to placebo were evaluated at each node during treatment.(Week 4, 8, 12, and 48)
- The effects of IBI362 on mean sitting diastolic arterial pressure (msDBP) compared to placebo were evaluated at each node during treatment.(Week 4, 8, 12, 16, 24, and 48)
- The effects of IBI362 on mean arterial pressure (MAP) compared to placebo were evaluated at each node during treatment.(Week 4, 8, 12, 16, 24, and 48)
- The effect of IBI362 on blood pressure reduction efficacy and compliance compared to placebo was evaluated at each node during treatment.(Week 4, 8, 12, 16, 24, 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on body mass index (BMI) compared with placebo.(Week 16, 24, and 48)
- The effect of IBI362 on blood pressure reduction efficacy and compliance compared to placebo was evaluated at each node during treatment.(Week 4, 8, 12, 16, 24, and 48)
- The effects of IBI362 on 24-hour of Ambulatory Blood Pressure Monitoring (ABPM) compared with placebo were evaluated at each node during treatment.(Week 8, 12, 16, 24, and 48)
- The effects of IBI362 on day-to-night mean SBP and mean DBP of Ambulatory Blood Pressure Monitoring (ABPM) compared with placebo were evaluated at each node during treatment.(Week 8, 12, 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo.(Week 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on waist circumference compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on fasting blood glucose compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on glycated hemoglobin (HbA1c) compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on total cholesterol (TC).(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on Lp(a) compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on low-density lipoprotein cholesterol (LDL-C) compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on high-density lipoprotein cholesterol (HDL-C) compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on non-high-density lipoprotein (non-HDL-C) compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on very low-density lipoprotein cholesterol (VLDL-C) compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on triglycerides (TG) compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on Apo B compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on estimated glomerular filtration rate (eGFR) compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on urine protein compared with placebo.(Week 16, 24, and 48)
- During treatment, IBI362 was evaluated for the effects of IBI362 on cystatin-C compared with placebo.(Change from baseline in cystatin-C at 16, 24, and 48 weeks.)
- During treatment, IBI362 was evaluated for the effects of IBI362 on blood uric acid compared with placebo.(Week 16, 24, and 48)
研究者
研究点 (1)
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