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Phase III Study of HRS-7535 for Hypertension With Overweight or Obesity
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
Lead sponsor
Asset
KAI-7535 / HRS-7535
Oral · GLP-1 agonist
Listed sites
2
Recruiting sites
—
Enrollment
648
estimated
Study population
Hypertension, Obesity / overweight
Key I/E criterion
•BMI ≥24
Primary endpoint
•SBP relative
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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);
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointPercentage of weight change at Week 24 and 48
Time frame:at Week 24 and 48
descriptive
Cardiometabolic biomarkers
2 endpointsChanges in SBP during 24-hour ambulatory blood pressure monitoring (ABPM) at Week 24 and Week 48;
Time frame:at Week 24 and Week 48;
descriptive
The changes in blood lipid at Week 24 and 48;
Time frame:at Week 24 and 48;
descriptive
Other (unclassified)
1 endpointChange in SBP relative to baseline at Week 24
Time frame:at Week 24
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.