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

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391710
• Other study ID #: HRS9531-205
• Status: Recruiting
• Phase: Phase 2
• Start date: May 6, 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: Zhou Li
• Phone: +86 17721288193
• Email: zhou.li.zl69[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Drug:
• HRS9531
subcutaneous
• Placebo
subcutaneous

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score		From baseline (week 0) to week 36
Primary	Change in body weight		From baseline (week 0) to week 36
Secondary	Hierarchical composite of time to all-cause death		From baseline (week 0) to week 36,52
Secondary	Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit		From baseline (week 0) to week 36,52
Secondary	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
Secondary	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
Secondary	Change in KCCQ clinical summary score		From baseline (week 0) to week 52
Secondary	Change in body weight		From baseline (week 0) to week 52
Secondary	Change in C-Reactive Protein (CRP)		From baseline (week 0) to week 36,52
Secondary	Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)		From baseline (week 0) to week 36,52