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NCT Number: NCT07528027

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

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;

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

HRS-7535

Drug

HRS-7535

Placebo

Drug

Placebo

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;

Study contacts

Contact information is provided by the study sponsor or research team.

Pengfei Wang

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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