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RecruitingNCT07528027Updated Sep 24, 2026

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

A Phase 3 interventional study of HRS-7535 and Placebo in Hypertension With Overweight or Obesity, sponsored by Shandong Suncadia Medicine Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
648
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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;

02

Conditions studied

  • Hypertension With Overweight or Obesity

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03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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);
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
648 participants (estimated)

Study arms

  • Experimental
    Treatment group A: HRS-7535

    Drug: HRS-7535

  • Placebo comparator
    Treatment group B: Placebo

    Drug: Placebo

Interventions

  • DrugHRS-7535

    HRS-7535

  • DrugPlacebo

    Placebo

05

What researchers measure

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;

06

Study locations

2 of 2 sites recruiting
  • Peking University First Hospital
    Beijing, Beijing Municipality 100034, China
    • Jianping Li · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang 163711, China
    • Yue Li · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07528027
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Apr 14, 2026
Start date
May 29, 2026
Primary completion
Dec 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

Pengfei Wang
Contact
pengfei.wang.pw5@hengrui.com
0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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