Blood pressure medicine HRS-7535 tested in adults with hypertension and overweight/obesity
Official 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
Run by Shandong Suncadia Medicine Co., Ltd. · NCT07528027 · Data updated 2026-11-12
This study tests whether HRS-7535 lowers blood pressure better than placebo in adults with hypertension who are overweight or obese.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 648 (estimated) |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | May 29, 2026 |
| Main results expected | December 2027 |
| Study ends | January 2028 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07528027 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–70 with hypertension and overweight or obesity, whose office blood pressure falls within the study ranges and who meet treatment history criteria.
✕Probably not a fit
Individuals not experiencing blood pressure reduction with HRS-7535 or whose BP criteria are not met may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3, randomized, placebo-controlled trial evaluating the effect of HRS-7535 on blood pressure in adults aged 18 to 70 with hypertension and overweight or obesity. Participants are assigned to receive either HRS-7535 or placebo and are monitored for changes in office blood pressure. Eligibility includes specific blood pressure ranges and current antihypertensive treatment status, with BMI criteria reflecting the overweight/obese population. The trial is conducted at two Chinese hospitals with a lead sponsor based in China.
Why it matters
Potential benefit: If successful, participants receiving HRS-7535 may experience better blood pressure control compared with placebo.
How similar studies have gone: Phase 3 trials of comparable antihypertensive agents have shown favorable BP reduction, but this exact mechanism is being tested in this population.
Who can join: the full rules
Show full inclusion / exclusion 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);
Where it's running
-
Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting -
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China Recruiting
Study contacts
- Study coordinator: Pengfei Wang
- Email: pengfei.wang.pw5@hengrui.com
- Phone: 0518-82342973
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.