Phase II Clinical Study of HRS-9563 in Patients With Mild to Moderate Hypertension

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-9563 in Patients With Mild to Moderate Hypertension

This study aims to evaluate the efficacy and safety of HRS-9563 in patients with mild to moderate hypertension, and to explore its appropriate dosage.

Study Overview

• Status: Recruiting
• Conditions: Mild to Moderate Hypertension
• Intervention / Treatment: Drug: HRS-9563 Injection; Drug: sodium chloride injection

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yuhan Guo; Phone Number: +0518-81220121; Email: yuhan.guo.yg21@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • Beijing AnZhen Hospital, Capital Medical University
      • Principal Investigator: Jun Cai

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. The subject voluntarily signs the informed consent form.
2. Male or female, aged ≥ 18 years and ≤ 75 years;
3. Patients with mild to moderate hypertension;
4. At the Screening and Baseline periods, the mean sitting office systolic blood pressure is > 130 mmHg, and the 24-hour mean systolic blood pressure assessed by ABPM at Screening is ≥ 130 mmHg and < 160 mmHg.

Exclusion Criteria:

1. Secondary hypertension;
2. Orthostatic hypotension;
3. Type 1 diabetes or poorly controlled type 2 diabetes;
4. Occurrence of any cardiovascular or cerebrovascular event within 6 months prior to screening;
5. Presence of uncontrolled severe arrhythmia within 6 months prior to screening;
6. Suspected allergy to the investigational drug or any of its components;
7. Other diseases requiring Renin-Angiotensin-Aldosterone System (RAAS) inhibitor therapy, besides hypertension;
8. Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;
9. Use of any medication affecting blood pressure within 4 weeks prior to screening, or planned use during the study period;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-9563 or Placebo Injection; low dose	Drug: HRS-9563 Injection; HRS-9563 Injection; Drug: sodium chloride injection; sodium chloride injection
Experimental: Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose	Drug: HRS-9563 Injection; HRS-9563 Injection; Drug: sodium chloride injection; sodium chloride injection
Experimental: Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose	Drug: HRS-9563 Injection; HRS-9563 Injection; Drug: sodium chloride injection; sodium chloride injection
Experimental: Treatment group D: HRS-9563 or Placebo Injection; high dose	Drug: HRS-9563 Injection; HRS-9563 Injection; Drug: sodium chloride injection; sodium chloride injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 6	at 6 months after initiation of administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 3	at 3 months after initiation of administration
Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 9	at 9 months after initiation of administration
Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 3	at 3 months after initiation of administration
Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 6	at 6 months after initiation of administration
Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 9	at 9 months after initiation of administration
Change from baseline in mean sitting office systolic blood pressure at month 3;	at 3 months after initiation of administration
Change from baseline in mean sitting office systolic blood pressure at month 6;	at 6 months after initiation of administration
Change from baseline in mean sitting office systolic blood pressure at month 9;	at 9 months after initiation of administration
Change from baseline in mean sitting office diastolic blood pressure at month 3;	at 3 months after initiation of administration
Change from baseline in mean sitting office diastolic blood pressure at month 6;	at 6 months after initiation of administration
Change from baseline in mean sitting office diastolic blood pressure at month 9;	at 9 months after initiation of administration

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: HRS-9563-201

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