Fluid Retention Caused by Heart FailurePhase 2NCT07318103
Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention
A Phase 2 study testing HRS-9057 injection set and 5% Glucose Injection or 0.9% sodium chloride injection in people with Fluid Retention Caused by Heart Failure, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Retention Caused by Heart Failure
- What is being tested?
- HRS-9057 injection set and 5% Glucose Injection or 0.9% sodium chloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- The signs and symptoms of fluid retention are judged by the investigator as mainly attributable to non-cardiac causes, including acute exacerbation of chronic obstructive pulmonary disease, severe anemia, decompensated cirrhosis, nephrotic syndrome, and so on.
- 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;
Show all 16Show fewer
- 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.
- Individuals with a body mass index (BMI) below 18.5 kg/m² ;
- Symptomatic hypotension and/or systolic blood pressure <90 mmHg; 16. Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI2009] formula based on serum creatinine), or undergoing/planned for haemodialysis or ultrafiltration therapy;
- 17. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3× the upper limit of normal (ULN), except if assessed by the investigator as due to heart failure; 18. Serum sodium > ULN or <125 mmol/L; 19. Serum potassium > ULN 20. Known or suspected allergy to tolvaptan tablets, OPC-61815 injection, or HRS-9057 injection components; 21. Participation in any drug or medical device clinical trial within 3 months prior to screening, defined as: signing the informed consent and using the investigational product (excluding placebo) or investigational medical device; or still within 5 half-lives of the investigational drug (whichever is longer); 22. Individuals who currently require blood transfusion therapy. 23. Participants with mental incapacity or speech disorders, or unable to fully understand or participate in the trial process, or unable to fully understand potential adverse reactions during the study; 24. Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use protocol-specified contraception during the trial and for 1 week after the last dose; 25. As judged by the investigator, any condition affecting participant safety or otherwise interfering with the evaluation of trial results (medical, psychological, social, or geographical factors, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Yuhui Zhang
About this study
Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Injectable HRS-9057 in Patients With Heart Failure-induced Fluid Retention
Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention
- Conditions
- Fluid Retention Caused by Heart Failure
- Being tested
- HRS-9057 injection set, 5% Glucose Injection or 0.9% sodium chloride injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9057 injection setDrug
HRS-9057 injection set
5% Glucose Injection or 0.9% sodium chloride injectionDrug
5% Glucose Injection or 0.9% sodium chloride injection
| Study group | Role | What they receive |
|---|---|---|
| HRS-9057 for injection | Experimental | Not described Receives: Drug: HRS-9057 injection set |
| 5% Glucose Injection or 0.9% sodium chloride injection | Placebo comparator | Not described Receives: Drug: 5% Glucose Injection or 0.9% sodium chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in weight from baseline on day 8
Measured: within 8 days after the start of administration
Secondary outcomes (7)
Absolute change in body weight from baseline at each visit during treatment
Measured: 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
Measured: after the last case has left the group，within 1years after the first case in
Total dose of loop diuretics during treatment
Measured: 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
Measured: within 8 days after the start of administration
Incidence of hypernatraemia during treatment
Measured: within 8 days after the start of administration
Proportion of participants who experienced hypovolaemic events during treatment and needed to discontinue the trial medication
Measured: within 8 days after the start of administration
Detection indicators: concentrations of HRS-9057, tolvaptan and other major metabolites (if applicable)
Measured: within 8 days after the start of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start31 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Retention Caused by Heart FailureStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318103
- Sponsor's protocol ID
- HRS-9057-201
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Injectable HRS-9057 in Patients With Heart Failure-induced Fluid Retention
- ClinicalTrials.gov ID
- NCT07318103
- Acronym / sponsor ID
- HRS-9057-201
- Conditions
- Fluid Retention Caused by Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
- The signs and symptoms of fluid retention are judged by the investigator as mainly attributable to non-cardiac causes, including acute exacerbation of chronic obstructive pulmonary disease, severe anemia, decompensated cirrhosis, nephrotic syndrome, and so on.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-9057 injection setHRS-9057 injection set | Drug | HRS-9057 for injection |
| 5% Glucose Injection or 0.9% sodium chloride injection5% Glucose Injection or 0.9% sodium chloride injection | Drug | 5% Glucose Injection or 0.9% sodium chloride injection |
Primary outcome
Absolute change in weight from baseline on day 8
Time frame: within 8 days after the start of administration
7 secondary outcomes
Absolute change in body weight from baseline at each visit during treatment
Time frame: 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
Time frame: after the last case has left the group，within 1years after the first case in
Total dose of loop diuretics during treatment
Time frame: 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
Time frame: within 8 days after the start of administration
Incidence of hypernatraemia during treatment
Time frame: within 8 days after the start of administration
Proportion of participants who experienced hypovolaemic events during treatment and needed to discontinue the trial medication
Time frame: within 8 days after the start of administration
Detection indicators: concentrations of HRS-9057, tolvaptan and other major metabolites (if applicable)
Time frame: within 8 days after the start of administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-9057 injection set and 5% Glucose Injection or 0.9% sodium chloride injection in people with Fluid Retention Caused by Heart Failure, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Na Li (+0518-82342973, na.li.nl80@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in weight from baseline on day 8 (time frame: within 8 days after the start of administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.