Hypertension With Overweight or ObesityPhase 3NCT07528027
Phase III Study of HRS-7535 for Hypertension With Overweight or Obesity
A Phase 3 study testing HRS-7535 in people with Hypertension With Overweight or Obesity, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial 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; Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension With Overweight or Obesity
- What is being tested?
- HRS-7535
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 648 participants
- Where
- 2 sitesChina
- Study dates
- 29 May 2026to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jianping Li
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 163711
Yue Li
About this study
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
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;
- Conditions
- Hypertension With Overweight or Obesity
- Being tested
- HRS-7535, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7535Drug
HRS-7535
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-7535 | Experimental | Not described Receives: Drug: HRS-7535 |
| Treatment group B: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SBP relative to baseline at Week 24
Measured: at Week 24
Secondary outcomes (3)
Changes in SBP during 24-hour ambulatory blood pressure monitoring (ABPM) at Week 24 and Week 48;
Measured: at Week 24 and Week 48;
Percentage of weight change at Week 24 and 48
Measured: at Week 24 and 48
The changes in blood lipid at Week 24 and 48;
Measured: at Week 24 and 48;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start29 May 2026
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension With Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528027
- Sponsor's protocol ID
- HRS-7535-306
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07528027
- Acronym / sponsor ID
- HRS-7535-306
- Conditions
- Hypertension With Overweight or Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-7535 | Experimental | Drug: HRS-7535 |
| Treatment group B: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-7535HRS-7535 | Drug | Treatment group A: HRS-7535 |
| PlaceboPlacebo | Drug | Treatment group B: Placebo |
Primary outcome
Change in SBP relative to baseline at Week 24
Time frame: at Week 24
3 secondary outcomes
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;
Percentage of weight change at Week 24 and 48
Time frame: at Week 24 and 48
The changes in blood lipid at Week 24 and 48;
Time frame: at Week 24 and 48;
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS-7535 in people with Hypertension With Overweight or Obesity, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengfei Wang (0518-82342973, pengfei.wang.pw5@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SBP relative to baseline at Week 24 (time frame: at Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.