Mild to Moderate HypertensionPhase 2NCT07297797

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

A Phase 2 study testing HRS-9563 Injection and sodium chloride injection in people with Mild to Moderate Hypertension, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Mild to Moderate Hypertension
What is being tested?: HRS-9563 Injection and sodium chloride injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 238 participants
Where: 1 siteChina
Study dates: 14 Jan 2026to Oct 2027
Phase: Phase 2

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject voluntarily signs the informed consent form.
Male or female, aged ≥ 18 years and ≤ 75 years;
Patients with mild to moderate hypertension;
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.

Who cannot join

Secondary hypertension;
Orthostatic hypotension;
Type 1 diabetes or poorly controlled type 2 diabetes;
Occurrence of any cardiovascular or cerebrovascular event within 6 months prior to screening;
Presence of uncontrolled severe arrhythmia within 6 months prior to screening;
Suspected allergy to the investigational drug or any of its components;

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Other diseases requiring Renin-Angiotensin-Aldosterone System (RAAS) inhibitor therapy, besides hypertension;
Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;
Use of any medication affecting blood pressure within 4 weeks prior to screening, or planned use during the study period;

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: 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.

Conditions: Mild to Moderate Hypertension
Being tested: HRS-9563 Injection, sodium chloride injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-9563 InjectionDrug
HRS-9563 Injection
sodium chloride injectionDrug
sodium chloride injection

Study groups in NCT07297797
Study group	Role	What they receive
Treatment group A: HRS-9563 or Placebo Injection; low dose	Experimental	Not described Receives: Drug: HRS-9563 Injection; Drug: sodium chloride injection
Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose	Experimental	Not described Receives: Drug: HRS-9563 Injection; Drug: sodium chloride injection
Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose	Experimental	Not described Receives: Drug: HRS-9563 Injection; Drug: sodium chloride injection
Treatment group D: HRS-9563 or Placebo Injection; high dose	Experimental	Not described Receives: Drug: HRS-9563 Injection; Drug: sodium chloride injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 6
Measured: at 6 months after initiation of administration

Secondary outcomes (7)

Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 3
Measured: at 3 months after initiation of administration
Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 3
Measured: at 3 months after initiation of administration
Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 6
Measured: at 6 months after initiation of administration
Change from baseline in mean sitting office systolic blood pressure at month 3;
Measured: at 3 months after initiation of administration
Change from baseline in mean sitting office systolic blood pressure at month 6;
Measured: at 6 months after initiation of administration
Change from baseline in mean sitting office diastolic blood pressure at month 3;
Measured: at 3 months after initiation of administration
Change from baseline in mean sitting office diastolic blood pressure at month 6;
Measured: at 6 months after initiation of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 2026Oct 2027

First posted22 Dec 2025
Study start14 Jan 2026
Primary completionDec 2026 (estimated)
Study completionOct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mild to Moderate HypertensionStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07297797
Sponsor's protocol ID: HRS-9563-201
Status last verified: Dec 2025
First submitted: 9 Dec 2025
Last updated: 31 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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