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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07297797

Enrollment

234

Registered

2025-12-22

Start date

2026-01-14

Completion date

2027-10-01

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Hypertension

Brief summary

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.

Interventions

DRUGHRS-9563 Injection

HRS-9563 Injection

DRUGsodium chloride injection

sodium chloride injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

China

Contacts

CONTACTYuhan Guo

yuhan.guo.yg21@hengrui.com+0518-81220121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026