Heart Failure With Volume OverloadPhase 1NCT06506994
A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
A Phase 1 study testing HRS-9057 and Tolvaptan in people with Heart Failure With Volume Overload, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure With Volume Overload
- What is being tested?
- HRS-9057 and Tolvaptan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2024to 29 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18-75 years at the time of signing informed consent.
- Diagnosed as chronic heart failure at least 1 month prior to screening.
- Patients with CHF in whom lower limb edema, pulmonary congestion, jugular venous distension or hepatomegaly due to volume overload is present despite diuretics treatment.
Who cannot join
- Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
- Hypovolemic hyponatremia.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510285
About this study
Official title: An Open Label, Tolvaptan-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Ascending Dose of HRS-9057 in Heart Failure With Volume Overload
The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets.
- Conditions
- Heart Failure With Volume Overload
- Being tested
- HRS-9057, Tolvaptan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9057Drug
HRS-9057 injection dose 1
HRS-9057Drug
HRS-9057 injection dose 2
TolvaptanDrug
Tolvaptan tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-9057/ Tolvaptan | Experimental | Not described Receives: Drug: HRS-9057; Drug: Tolvaptan |
| Treatment group B: HRS-9057/ Tolvaptan | Experimental | Not described Receives: Drug: HRS-9057; Drug: Tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of any adverse events (AEs)
Measured: baseline up to Day 14
Secondary outcomes (12)
Tmax for HRS-9057
Measured: Predose on Day 1 through Day 6
Cmax for HRS-9057
Measured: Predose on Day 1 through Day 6
Daily urine volume
Measured: Predose on Day 1 through Day 7
Daily fluid balance
Daily fluid balance is calculated by subtracting daily urine volume from daily fluid intake.
Measured: Predose on Day 1 through Day 7
Serum sodium concentration
Measured: Predose on Day 1 through Day 6
Serum osmolality
Measured: Predose on Day 1 through Day 6
Urine osmolality
Measured: Predose on Day 1 through Day 7
Body weight
Measured: baseline to Day 8
Lower limb edema change from baseline
The severity of edema in the subject's tibial border or dorsum of the foot will be assessed in the sitting position using a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe) by the investigator. The percentage of subjects in whom the lower limb edema was improved or worsening at Day 8 will be evaluated.
Measured: baseline to Day 8
Jugular venous distension change from baseline
Whether or not the subject has jugular venous distension will be documented. If distension is observed, the vertical height (in centimeters) from the sternal angle to the highest point of pulsation of the internal jugular vein will be documented and the change from baseline to Day 8 will be evaluated.
Measured: baseline to Day 8
Pulmonary congestion change from baseline
The investigator will perform chest X-ray at baseline and Day 8 to assess the severity of pulmonary congestion using a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). The percentage of subjects in whom pulmonary congestion was improved or worsening at Day 8 will be evaluated.
Measured: baseline to Day 8
New York Heart Association (NYHA) classification change from baseline
Measured: baseline to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start16 Aug 2024
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Volume OverloadStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HRS-9057 injection was compared with Tolvaptan tablets
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
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
- NCT06506994
- Sponsor's protocol ID
- HRS-9057-103
- Status last verified
- Nov 2025
- First submitted
- 28 Jun 2024
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Tolvaptan-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Ascending Dose of HRS-9057 in Heart Failure With Volume Overload
- ClinicalTrials.gov ID
- NCT06506994
- Acronym / sponsor ID
- HRS-9057-103
- Conditions
- Heart Failure With Volume Overload
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 18 Jul 2024 (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.
The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- HRS-9057 injection was compared with Tolvaptan tablets
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-9057/ Tolvaptan | Experimental | Drug: HRS-9057, Drug: Tolvaptan |
| Treatment group B: HRS-9057/ Tolvaptan | Experimental | Drug: HRS-9057, Drug: Tolvaptan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age 18-75 years at the time of signing informed consent.
- Diagnosed as chronic heart failure at least 1 month prior to screening.
- Patients with CHF in whom lower limb edema, pulmonary congestion, jugular venous distension or hepatomegaly due to volume overload is present despite diuretics treatment.
Key exclusion criteria (2 listed)
- Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
- Hypovolemic hyponatremia.
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-9057HRS-9057 injection dose 1 | Drug | Treatment group A: HRS-9057/ Tolvaptan |
| HRS-9057HRS-9057 injection dose 2 | Drug | Treatment group B: HRS-9057/ Tolvaptan |
| TolvaptanTolvaptan tablets | Drug | Treatment group A: HRS-9057/ Tolvaptan, Treatment group B: HRS-9057/ Tolvaptan |
Primary outcome
The incidence and severity of any adverse events (AEs)
Time frame: baseline up to Day 14
12 secondary outcomes
Tmax for HRS-9057
Time frame: Predose on Day 1 through Day 6
Cmax for HRS-9057
Time frame: Predose on Day 1 through Day 6
Daily urine volume
Time frame: Predose on Day 1 through Day 7
Daily fluid balance
Time frame: Predose on Day 1 through Day 7
Serum sodium concentration
Time frame: Predose on Day 1 through Day 6
Serum osmolality
Time frame: Predose on Day 1 through Day 6
Urine osmolality
Time frame: Predose on Day 1 through Day 7
Body weight
Time frame: baseline to Day 8
Lower limb edema change from baseline
Time frame: baseline to Day 8
Jugular venous distension change from baseline
Time frame: baseline to Day 8
Pulmonary congestion change from baseline
Time frame: baseline to Day 8
New York Heart Association (NYHA) classification change from baseline
Time frame: baseline to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-9057 and Tolvaptan in people with Heart Failure With Volume Overload, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 17 Nov 2025. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of any adverse events (AEs) (time frame: baseline up to Day 14). 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 17 Nov 2025.