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

Phase 2

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Drug: HRS9531; Drug: Placebo

• Registration Number: NCT06391710
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Study Start: 2024-05-06
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-09
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS9531	HRS9531	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score	From baseline (week 0) to week 36
Change in body weight	From baseline (week 0) to week 36

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China