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Active, not recruitingNCT07297797Updated Jul 31, 2026

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

A Phase 2 interventional study of HRS-9563 Injection and sodium chloride injection in Mild to Moderate Hypertension, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mild to Moderate Hypertension
03

In context

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 65 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
238 participants (actual)

Study arms

  • Experimental
    Treatment group A: HRS-9563 or Placebo Injection; low dose

    Drug: HRS-9563 Injection · Drug: sodium chloride injection

  • Experimental
    Treatment group B: HRS-9563 or Placebo Injection; Intermediate dose

    Drug: HRS-9563 Injection · Drug: sodium chloride injection

  • Experimental
    Treatment group C: HRS-9563 or Placebo Injection; Medium to high dose

    Drug: HRS-9563 Injection · Drug: sodium chloride injection

  • Experimental
    Treatment group D: HRS-9563 or Placebo Injection; high dose

    Drug: HRS-9563 Injection · Drug: sodium chloride injection

Interventions

  • DrugHRS-9563 Injection

    HRS-9563 Injection

  • Drugsodium chloride injection

    sodium chloride injection

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Change from baseline in mean sitting office systolic blood pressure at month 3;

    Time frame: at 3 months after initiation of administration

  5. Change from baseline in mean sitting office systolic blood pressure at month 6;

    Time frame: at 6 months after initiation of administration

  6. Change from baseline in mean sitting office diastolic blood pressure at month 3;

    Time frame: at 3 months after initiation of administration

  7. Change from baseline in mean sitting office diastolic blood pressure at month 6;

    Time frame: at 6 months after initiation of administration

07

Study locations

1 site
  • Beijing Anzhen Hospital, Capital Medical University
    Beijing, Beijing Municipality 100029, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07297797
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 22, 2025
Start date
Jan 14, 2026
Primary completion
Dec 2026 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jul 31, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Fujian Shengdi Pharmaceutical Co., Ltd.

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