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

Phase

Condition

Chest Pain

Congestive Heart Failure

Hyponatremia

Treatment

Placebo

HRS9531

Clinical Study ID

NCT06391710

HRS9531-205

Ages > 18
All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design