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

Search all trials

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
Are there results?: Not yet: the study is under way

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;

Show all 9Show fewer

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.
More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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?

See locations

Active, not recruitingPhase 2
A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
Hypertension
RecruitingPhase 4
Sitogilun Malate Plus Amlodipine in Patients With Hypertension and Risk of Early Kidney Damage
Hypertension
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
RecruitingPhase 2
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
Hypertension
RecruitingPhase 1
A Study of IBI3016 in Japanese Participants
Hypertension

All Mild to Moderate Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07297797
Acronym / sponsor ID: HRS-9563-201
Conditions: Mild to Moderate Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 238 participants (actual)
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 14 Jan 2026 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Oct 2027 (estimated)
First posted: 22 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Treatment group A: HRS-9563 or Placebo Injection; low dose	Experimental	Drug: HRS-9563 Injection, Drug: sodium chloride injection
Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose	Experimental	Drug: HRS-9563 Injection, Drug: sodium chloride injection
Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose	Experimental	Drug: HRS-9563 Injection, Drug: sodium chloride injection
Treatment group D: HRS-9563 or Placebo Injection; high dose	Experimental	Drug: HRS-9563 Injection, Drug: sodium chloride injection

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS-9563 InjectionHRS-9563 Injection	Drug	Treatment group A: HRS-9563 or Placebo Injection; low dose, Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose, Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose, Treatment group D: HRS-9563 or Placebo Injection; high dose
sodium chloride injectionsodium chloride injection	Drug	Treatment group A: HRS-9563 or Placebo Injection; low dose, Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose, Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose, Treatment group D: HRS-9563 or Placebo Injection; high dose

Primary outcome

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

7 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Individual participant dataSharing planned: Undecided

Related trials for Mild to Moderate Hypertension

Active, not recruitingPhase 2
A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
Hypertension
RecruitingPhase 4
Sitogilun Malate Plus Amlodipine in Patients With Hypertension and Risk of Early Kidney Damage
Hypertension
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
RecruitingPhase 2
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
Hypertension
RecruitingPhase 1
A Study of IBI3016 in Japanese Participants
Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 6 (time frame: at 6 months after initiation of administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07297797.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.