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NCT Number: NCT07297797

Phase II Clinical Study 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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;

Treatment and study plan

HRS-9563 Injection

Drug

HRS-9563 Injection

sodium chloride injection

Drug

sodium chloride injection

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

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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