NCT07528027招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 for the Treatment of Hypertension in Participants With Obesity or Overweight
Shandong Suncadia Medicine Co., Ltd.2 个研究点 分布在 1 个国家目标入组 648 人开始时间: 2026年5月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 648
- 试验地点
- 2
- 主要终点
- Change in SBP relative to baseline at Week 24
研究概览
简要总结
The main objective of this study is to demonstrate the superior efficacy of HRS-7535 in controlling blood pressure compared to placebo in subjects with hypertension and overweight or obesity;
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On the day of signing the informed consent form, the age should be between 18 and 70 years old, with no gender restrictions;
- •When screening or randomizing, the average office blood pressure meets any of the following conditions: ① 140 mmHg ≤ SBP < 170 mmHg, and DBP < 110 mmHg; ② 90 mmHg ≤ DBP < 110 mmHg, and 130 mmHg ≤ SBP < 170 mmHg;
- •Patients with untreated hypertension, or those who have received stable doses of any or all of the following classes of antihypertensive medications within 30 days prior to screening: 1) angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB), 2) thiazides and thiazide-like diuretics, 3) calcium channel blockers. Patients who are currently receiving stable doses of beta blockers (such as metoprolol or atenolol) or mineralocorticoid receptor antagonists (such as spironolactone) and intend to continue these treatments at their current doses may be included in this study;
- •During screening, BMI should be ≥24 kg/m2;
排除标准
- •Having a known secondary cause of hypertension
- •History of previously diagnosed heart failure with reduced ejection fraction (HFrEF);
- •Those who have undergone coronary revascularization within the previous 90 days or plan to undergo it during the trial period;
- •Diagnosed or suspected with type 1 diabetes, special type of diabetes, or secondary diabetes (excluding gestational diabetes);
- •History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/requiring treatment of gallbladder disease (excluding those who have undergone cholecystectomy but are still eligible for enrollment as determined by the investigator);
研究组 & 干预措施
Treatment group B: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Treatment group A: HRS-7535
Experimental
干预措施: HRS-7535 (Drug)
结局指标
主要结局
Change in SBP relative to baseline at Week 24
时间窗: at Week 24
次要结局
- Changes in SBP during 24-hour ambulatory blood pressure monitoring (ABPM) at Week 24 and Week 48;(at Week 24 and Week 48;)
- Percentage of weight change at Week 24 and 48(at Week 24 and 48)
- The changes in blood lipid at Week 24 and 48;(at Week 24 and 48;)
研究者
研究点 (2)
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