Overview

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.

Eligibility

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.