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

NCT07528027 | Not Yet Recruiting Phase 3

• 1 other identifier: HRS-7535-306
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 2

Brief 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;

Conditions

Hypertension With Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• Change in SBP relative to baseline at Week 24

  at Week 24

Secondary Outcomes (3)

• Changes in SBP during 24-hour ambulatory blood pressure monitoring (ABPM) at Week 24 and Week 48;

  at Week 24 and Week 48;

• Percentage of weight change at Week 24 and 48

  at Week 24 and 48

• The changes in blood lipid at Week 24 and 48;

  at Week 24 and 48;

Study Arms (2)

Treatment group A: HRS-7535

EXPERIMENTAL

Drug: HRS-7535

Treatment group B: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Treatment group B: Placebo

HRS-7535 DRUG

HRS-7535

Treatment group A: HRS-7535

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 163711, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pengfei Wang

CONTACT

0518-82342973; pengfei.wang.pw5@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (2)