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New injection aims to shed fluid fast in heart failure patients

NCT ID NCT07318103

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tests an injectable drug called HRS-9057 in 153 adults hospitalized with heart failure who have fluid retention. The main goal is to see if the drug reduces weight (a sign of fluid loss) by day 8 compared to a placebo. Researchers will also check safety and whether patients need extra diuretics.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 153 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged ≥18 years on the day of signing the informed consent, regardless of gender; 2. Hospitalization due to heart failure within 72 hours prior to randomization.; 3. 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;; 4. 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. 5. 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. Exclusion Criteria: 1. 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; 2. 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; 3. 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. 4. 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; 5. Previously diagnosed with hypertrophic cardiomyopathy and currently still in the hypertrophic phase (obstructive or non-obstructive), or amyloid cardiomyopathy; 6. Use of cardiac mechanical assist device at the time of screening; 7. Presence of hypovolemia or peripheral hypoperfusion at screening, assessed by the investigator as requiring treatment with vasoconstrictors, positive inotropic agents, or volume resuscitation. 8. Anuria at the time of screening; or urinary difficulties caused by urinary tract obstruction, stones or tumours; 9. Unable to perceive thirst at the time of screening, or any reason causing difficulty in fluid intake; 10. Unable to complete weight measurement or urine collection; 11. Consciousness impairment at the time of screening, or hepatic encephalopathy at the time of screening or a history of hepatic encephalopathy; 12. Any organ system malignancy within the last 5 years requiring ongoing treatment such as chemotherapy, radiotherapy, endocrine therapy, targeted therapy, etc.; 13. History of drug abuse or substance use within 1 year prior to screening. 14. Individuals with a body mass index (BMI) below 18.5 kg/m² ; 15. 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.).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100037, China