Phase III Study of HRS-7535 for Hypertension With Overweight or Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-7535, Placebo.
- Who it may be relevant to
- Registry conditions: Hypertension With Overweight or Obesity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug HRS-7535
HRS-7535 - Drug Placebo
Placebo
Primary outcome measures
- Change in SBP relative to baseline at Week 24 [Time frame: at Week 24]
Secondary outcome measures (3)
- Changes in SBP during 24-hour ambulatory blood pressure monitoring (ABPM) at Week 24 and Week 48; [Time frame: at Week 24 and Week 48;]
- Percentage of weight change at Week 24 and 48 [Time frame: at Week 24 and 48]
- The changes in blood lipid at Week 24 and 48; [Time frame: at Week 24 and 48;]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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);
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Peking University First Hospital — Beijing
- The First Affiliated Hospital of Harbin Medical University — Harbin
Identifiers
NCT: NCT07528027 · HRS-7535-306