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Not yet recruitingPhase 3

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

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

NCT IDNCT07528027
Org study IDHRS-7535-306

Timeline

Milestones

Study first posted2026-04-14actual
Last update posted2026-04-14actual
Study start2026-05estimated (month precision)
Primary completion2027-12estimated (month precision)
Study completion2028-01estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

HypertensionObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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

Cardiometabolic biomarkers
2
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Percentage of weight change at Week 24 and 48

Time frame:at Week 24 and 48

descriptive

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

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;

descriptive

Secondary/protocol endpoint

The changes in blood lipid at Week 24 and 48;

Time frame:at Week 24 and 48;

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Change in SBP relative to baseline at Week 24

Time frame:at Week 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.