Health TrialsbyHealthPanel

Phase III Study of HRS-7535 for Hypertension With Overweight or Obesity

ConditionHypertension With Overweight or Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

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;

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 and 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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-7535

    Drug

    HRS-7535

  • Placebo

    Drug

    Placebo

Treatment groups

648 Participants
are divided into 2 treatment groups
Group A: Treatment group A: HRS-7535Experimental treatment 1 intervention
Group B: Treatment group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in SBP relative to baseline at Week 24

Time frame
at Week 24

Secondary outcomes

1

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;
2

Percentage of weight change at Week 24 and 48

Time frame
at Week 24 and 48
3

The changes in blood lipid at Week 24 and 48;

Time frame
at Week 24 and 48;

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now