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

November 20, 2025 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Beijing Anzhen Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
subcutaneous
Experimental: HRS9531
Drug: HRS9531
subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Time Frame: From baseline (week 0) to week 36
From baseline (week 0) to week 36
Change in body weight
Time Frame: From baseline (week 0) to week 36
From baseline (week 0) to week 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Hierarchical composite of time to all-cause death
Time Frame: From baseline (week 0) to week 36,52
From baseline (week 0) to week 36,52
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
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
Time Frame: From baseline (week 0) to week 36,52
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
Time Frame: From baseline (week 0) to week 36,52
From baseline (week 0) to week 36,52
Change in KCCQ clinical summary score
Time Frame: From baseline (week 0) to week 52
From baseline (week 0) to week 52
Change in body weight
Time Frame: From baseline (week 0) to week 52
From baseline (week 0) to week 52
Change in C-Reactive Protein (CRP)
Time Frame: From baseline (week 0) to week 36,52
From baseline (week 0) to week 36,52
Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)
Time Frame: From baseline (week 0) to week 36,52
From baseline (week 0) to week 36,52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS9531-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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