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

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 Overview

• Status: Not yet recruiting
• Conditions: Hypertension With Overweight or Obesity
• Intervention / Treatment: Drug: Placebo; Drug: HRS-7535

• Study Type: Interventional
• Enrollment (Estimated): 648
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pengfei Wang; Phone Number: 0518-82342973; Email: pengfei.wang.pw5@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospital
      • Principal Investigator: Jianping Li
  • Heilongjiang
    • Harbin, Heilongjiang, China, 163711
      • The First Affiliated Hospital of Harbin Medical University
      • Principal Investigator: Yue Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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;
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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-7535	Drug: HRS-7535; HRS-7535
Placebo Comparator: Treatment group B: Placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in SBP relative to baseline at Week 24	at Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
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;

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: HRS-7535-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No