HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction

Fujian Shengdi Pharmaceutical

Status and phase: Active, not recruiting; Phase 2

Conditions: Heart Failure With Preserved Ejection Fraction

Treatments: Drug: HRS9531; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06391710

HRS9531-205

Details and patient eligibility

About

This was a multicenter, randomized, double-blind, placebo-parallel-controlled Phase II clinical study to evaluate the efficacy and safety of HRS9531 Injection compared to placebo in obese subjects with heart failure with preserved ejection fraction.

A total of 200 obese subjects with heart failure with preserved ejection fraction would be enrolled. Eligible subjects were randomly assigned to either HRS9531 group or placebo group and were treated with HRS9531 injection or placebo, respectively, for 52 weeks.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age above or equal to 18 years at the time of signing informed consent.
2. Body mass index (BMI) greater than or equal to 28.0 kg/m^2
3. New York Heart Association (NYHA) Class II-IV;
4. Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening

Exclusion criteria

1. Medical history of myocardial infarction, acute decompensated heart failure, heart failure requiring hospitalization or urgent heart failure visit, unstable angina, stroke, or transient ischemic attack within 30 days prior to or at screening;
2. Haemoglobin A1c (HbA1c) greater than or equal to 11.0% at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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203 participants in 2 patient groups, including a placebo group

HRS9531

Experimental group

Treatment:

Drug: HRS9531

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo