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

Fujian Shengdi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Heart Failure With Volume Overload

Treatments: Drug: Tolvaptan; Drug: HRS-9057

Study type: Interventional

Funder types: Industry

Identifiers

NCT06506994

HRS-9057-103

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age 18-75 years at the time of signing informed consent.
2. Diagnosed as chronic heart failure at least 1 month prior to screening.
3. 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Treatment group A: HRS-9057/ Tolvaptan

Experimental group

Treatment:

Drug: HRS-9057

Drug: HRS-9057

Drug: Tolvaptan

Treatment group B: HRS-9057/ Tolvaptan

Experimental group

Treatment:

Drug: HRS-9057

Drug: HRS-9057

Drug: Tolvaptan