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Completed

NCT Number: NCT06506994

A Study of HRS-9057 in Patients With Heart Failure and 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.

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Key information

Conditions

Heart Failure With Volume Overload

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510285, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
  • Hypovolemic hyponatremia.

Treatment and study plan

HRS-9057

Drug

HRS-9057 injection dose 1

Tolvaptan

Drug

Tolvaptan tablets

Primary outcomes

  1. The incidence and severity of any adverse events (AEs)

    Time frame: baseline up to Day 14

Secondary outcomes

  1. Tmax for HRS-9057

    Time frame: Predose on Day 1 through Day 6

  2. Cmax for HRS-9057

    Time frame: Predose on Day 1 through Day 6

  3. Daily urine volume

    Time frame: Predose on Day 1 through Day 7

  4. Daily fluid balance

    Time frame: Predose on Day 1 through Day 7

    Daily fluid balance is calculated by subtracting daily urine volume from daily fluid intake.

  5. Serum sodium concentration

    Time frame: Predose on Day 1 through Day 6

  6. Serum osmolality

    Time frame: Predose on Day 1 through Day 6

  7. Urine osmolality

    Time frame: Predose on Day 1 through Day 7

  8. Body weight

    Time frame: baseline to Day 8

  9. Lower limb edema change from baseline

    Time frame: baseline to Day 8

    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.

  10. Jugular venous distension change from baseline

    Time frame: baseline to Day 8

    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.

  11. Pulmonary congestion change from baseline

    Time frame: baseline to Day 8

    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.

  12. New York Heart Association (NYHA) classification change from baseline

    Time frame: baseline to Day 8

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.