NCT07297797

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_2

Timeline
17mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Oct 2027

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

January 14, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 26, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 9, 2025

Last Update Submit

January 23, 2026

Conditions

Mild to Moderate Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 6

    at 6 months after initiation of administration

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (4)

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

EXPERIMENTAL
Drug: HRS-9563 InjectionDrug: sodium chloride injection

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

EXPERIMENTAL
Drug: HRS-9563 InjectionDrug: sodium chloride injection

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

EXPERIMENTAL
Drug: HRS-9563 InjectionDrug: sodium chloride injection

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

EXPERIMENTAL
Drug: HRS-9563 InjectionDrug: sodium chloride injection

Interventions

HRS-9563 InjectionDRUG

HRS-9563 Injection

Treatment group A: HRS-9563 or Placebo Injection; low doseTreatment group B: HRS-9563 or Placebo Injection; Intermediate doseTreatment group C: HRS-9563 or Placebo Injection; Medium to high doseTreatment group D: HRS-9563 or Placebo Injection; high dose
sodium chloride injectionDRUG

sodium chloride injection

Treatment group A: HRS-9563 or Placebo Injection; low doseTreatment group B: HRS-9563 or Placebo Injection; Intermediate doseTreatment group C: HRS-9563 or Placebo Injection; Medium to high doseTreatment group D: HRS-9563 or Placebo Injection; high dose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Other diseases requiring Renin-Angiotensin-Aldosterone System (RAAS) inhibitor therapy, besides hypertension;
  • Use of any medication affecting blood pressure within 4 weeks prior to screening, or planned use during the study period;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Yuhan Guo

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

January 14, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

January 26, 2026

Record last verified: 2025-12

Locations

CN(1)