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NCT Number: NCT06391710

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRS9531

Drug

subcutaneous

Placebo

Drug

subcutaneous

Primary outcomes

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

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

  2. Change in body weight

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

Secondary outcomes

  1. Hierarchical composite of time to all-cause death

    Time frame: From baseline (week 0) to week 36,52

  2. Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit

    Time frame: From baseline (week 0) to week 36,52

  3. Hierarchical composite of time to the first heart failure events requiring hospitalisation or urgent heart failure visit

    Time frame: From baseline (week 0) to week 36,52

  4. Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 36, 52 weeks

    Time frame: From baseline (week 0) to week 36,52

  5. Change in KCCQ clinical summary score

    Time frame: From baseline (week 0) to week 52

  6. Change in body weight

    Time frame: From baseline (week 0) to week 52

  7. Change in C-Reactive Protein (CRP)

    Time frame: From baseline (week 0) to week 36,52

  8. Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)

    Time frame: From baseline (week 0) to week 36,52

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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