Hypertension With Overweight or Obesity
Conditions
Brief summary
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;
Interventions
DRUGHRS-7535
HRS-7535
DRUGPlacebo
Placebo
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. On the day of signing the informed consent form, the age should be between 18 and 70 years old, with no gender restrictions; 2. 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; 3. 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; 4. During screening, BMI should be ≥24 kg/m2;
Exclusion criteria
1. Having a known secondary cause of hypertension 2. History of previously diagnosed heart failure with reduced ejection fraction (HFrEF); 3. Those who have undergone coronary revascularization within the previous 90 days or plan to undergo it during the trial period; 4. Diagnosed or suspected with type 1 diabetes, special type of diabetes, or secondary diabetes (excluding gestational diabetes); 5. 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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SBP relative to baseline at Week 24 | at Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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; |
Countries
China
Contacts
CONTACTPengfei Wang
Outcome results
None listed