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NCT07528027From ClinicalTrials.govRecruiting

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

  • Hypertension With Overweight or Obesity

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Shandong Suncadia Medicine Co., Ltd.
Enrolment target
648
Started
29 May 2026
Main results due
December 2027
Study sites
2
Registry updated
24 September 2026

Can you take part?

  • Ages 18 years to 70 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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 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;
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);

What this study is about

In the sponsor’s own words, from the registry.

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;

Study sites(2)

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

    Recruiting

Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07528027. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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