HRS-9563 injection for adults with mild to moderate high blood pressure

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 will test whether the injectable medicine HRS-9563 lowers blood pressure in adults aged 18–75 with mild to moderate hypertension.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07297797 on ClinicalTrials.gov

What this trial studies

This Phase II interventional study gives adults with mild to moderate hypertension injections of HRS-9563 and includes sodium chloride injection as a comparator to explore appropriate dosing. Blood pressure will be monitored by office measurements and 24‑hour ambulatory blood pressure monitoring (ABPM) at screening and baseline, with follow-up visits to record safety and blood pressure changes. The trial focuses on participants whose mean sitting office systolic BP is >130 mmHg and 24‑hour ABPM systolic BP is ≥130 and <160 mmHg. Safety labs and adverse event monitoring will be used alongside efficacy measures to inform dose selection.

Who should consider this trial

Good fit: Adults 18–75 with mild to moderate hypertension (office systolic BP >130 mmHg and 24‑hour ABPM systolic BP ≥130 and <160 mmHg) who do not have secondary causes of hypertension and meet screening safety labs are ideal candidates.

Not a fit: Patients with secondary hypertension, recent cardiovascular or cerebrovascular events within 6 months, uncontrolled diabetes or severe arrhythmias, or those who require RAAS inhibitor therapy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, HRS-9563 could offer a new treatment option to lower blood pressure for people with mild to moderate hypertension.

How similar studies have performed: HRS-9563 appears to be a novel agent with limited published data, and prior early-phase work on injectable antihypertensives has shown mixed results.

Eligibility criteria

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:

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;

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yuhan Guo

Conditions Mild to Moderate Hypertension