Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention

NCT07318103 | Recruiting Phase 2

• 1 other identifier: HRS-9057-201
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention

Conditions

Fluid Retention Caused by Heart Failure

Outcome Measures

Primary Outcomes (1)

• Absolute change in weight from baseline on day 8

  within 8 days after the start of administration

Secondary Outcomes (7)

• Absolute change in body weight from baseline at each visit during treatment

  At each visit during treatment，within 8 days after the start of administration

• The proportion of participants requiring remedial treatment during therapy as defined by the protocol

  after the last case has left the group，within 1years after the first case in

• Total dose of loop diuretics during treatment

  within 8 days after the start of administration

• The incidence and severity of any adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) occurring after any treatment

  within 8 days after the start of administration

• Incidence of hypernatraemia during treatment

  within 8 days after the start of administration

Study Arms (2)

HRS-9057 for injection

EXPERIMENTAL

Drug: HRS-9057 injection set

5% Glucose Injection or 0.9% sodium chloride injection

PLACEBO COMPARATOR

Drug: 5% Glucose Injection or 0.9% sodium chloride injection

Interventions

HRS-9057 injection set DRUG

HRS-9057 injection set

HRS-9057 for injection

5% Glucose Injection or 0.9% sodium chloride injection DRUG

5% Glucose Injection or 0.9% sodium chloride injection

5% Glucose Injection or 0.9% sodium chloride injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years on the day of signing the informed consent, regardless of gender;
• Hospitalization due to heart failure within 72 hours prior to randomization.;
• At screening and prior to randomization, presence of heart failure symptoms (exertional dyspnea, paroxysmal nocturnal dyspnea, orthopnea, etc.) and at least one sign of fluid retention, including: auscultatory rales in the lungs, pitting edema of the lower extremities, pulmonary congestion confirmed by chest imaging;;
• NT-proBNP \> 450 pg/mL within 12 hours prior to randomization, or \> 600 pg/mL in patients with atrial fibrillation; or BNP \> 150 pg/mL, or \> 200 pg/mL in patients with atrial fibrillation.
• Judged to have poor response to loop diuretics before randomisation: presence of symptoms and signs of fluid retention after the administration of a cumulative dose of oral or intravenous loop diuretics equivalent to oral furosemide ≥40 mg (or equivalent doses of other loop diuretics#) within the past 12 hours.

You may not qualify if:

• Occurrence of myocardial infarction, stroke or transient ischemic attack, sustained ventricular tachycardia or ventricular fibrillation within 1 month prior to screening; or severe trauma or major/moderate surgery within 1 month prior to screening;
• Coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), valve repair/replacement, carotid or peripheral arterial revascularization, mechanical circulatory support device therapy, heart transplantation within 1 month prior to screening or planned during the study; or presence of severe coronary artery disease or cerebrovascular disease without revascularization that may lead to acute events during hospitalization;
• Fluid retention symptoms and signs determined by the investigator to be caused by non-cardiac diseases; or concomitant with other diseases that cause dyspnea or fluid retention, such as acute exacerbation of chronic obstructive pulmonary disease, severe anemia, decompensated liver cirrhosis, nephrotic syndrome, etc.
• The investigator determines that this hospitalization is due to acute heart failure requiring initial correction of the underlying cause, including: coronary atherosclerotic heart disease requiring revascularization, active myocarditis, constrictive pericarditis, cardiac tamponade, complex congenital heart disease, or symptomatic severe untreated primary valvular heart disease that may lead to acute events during hospitalization;
• Previously diagnosed with hypertrophic cardiomyopathy and currently still in the hypertrophic phase (obstructive or non-obstructive), or amyloid cardiomyopathy;
• Use of cardiac mechanical assist device at the time of screening;
• Presence of hypovolemia or peripheral hypoperfusion at screening, assessed by the investigator as requiring treatment with vasoconstrictors, positive inotropic agents, or volume resuscitation.
• Anuria at the time of screening; or urinary difficulties caused by urinary tract obstruction, stones or tumours;
• Unable to perceive thirst at the time of screening, or any reason causing difficulty in fluid intake;
• Unable to complete weight measurement or urine collection;
• Consciousness impairment at the time of screening, or hepatic encephalopathy at the time of screening or a history of hepatic encephalopathy;
• Any organ system malignancy within the last 5 years requiring ongoing treatment such as chemotherapy, radiotherapy, endocrine therapy, targeted therapy, etc.;
• History of drug abuse or substance use within 1 year prior to screening.
• Body mass index (BMI) less than 18.5 or greater than 35 kg/m2;
• Symptomatic hypotension and/or systolic blood pressure \<90 mmHg;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Interventions

Glucose; Sodium Chloride

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Na Li

CONTACT

+0518-82342973; na.li.nl80@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: November 21, 2025
• First Posted: January 5, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2025-11

Locations

CN (1)