A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction

Fujian Shengdi Pharmaceutical Co., Ltd.1 site in 1 country203 target enrollmentMay 6, 2024

ConditionsHeart Failure With Preserved Ejection Fraction

InterventionsHRS9531 Placebo

DrugsHRS9531 Placebo

Overview

Phase: Phase 2
Intervention: HRS9531
Conditions: Heart Failure With Preserved Ejection Fraction
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Enrollment: 203
Locations: 1
Primary Endpoint: Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 6, 2024

End Date

January 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, age above or equal to 18 years at the time of signing informed consent.
•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 at screening

Exclusion Criteria

•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;
•Haemoglobin A1c (HbA1c) greater than or equal to 11.0% at screening.

Arms & Interventions

HRS9531

Intervention: HRS9531

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score

Time Frame: From baseline (week 0) to week 36

Change in body weight

Time Frame: From baseline (week 0) to week 36

Secondary Outcomes

Hierarchical composite of time to all-cause death(From baseline (week 0) to week 36,52)
Hierarchical composite of time to the first heart failure events requiring hospitalisation or urgent heart failure visit(From baseline (week 0) to week 36,52)
Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit(From baseline (week 0) to week 36,52)
Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 36, 52 weeks(From baseline (week 0) to week 36,52)
Change in KCCQ clinical summary score(From baseline (week 0) to week 52)
Change in body weight(From baseline (week 0) to week 52)
Change in C-Reactive Protein (CRP)(From baseline (week 0) to week 36,52)
Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)(From baseline (week 0) to week 36,52)