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Clinical Trials in China / NCT06391710
Active, not recruiting Phase 2

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

NCT06391710 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd
Phase
Phase 2
Started
2024-05-06
Last updated
2025-11-24

Condition(s) studied

Heart Failure With Preserved Ejection Fraction

Investigational drug(s) / intervention(s)

HRS9531 →Placebo

HRS9531: subcutaneous

Placebo: subcutaneous

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality

More Fujian Shengdi Pharmaceutical Co., Ltd. trials in China

A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function Recruiting
A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity Active, not recruiting
A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants Active, not recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy Active, not recruiting
A Single-Dose Pharmacokinetic Study of HRS-4729 Injection in Healthy Participants and Patients With Renal Impairment Recruiting

Other trials for the same condition

Study of JK07 in Patients With Chronic Heart Failure Active, not recruiting
Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules Recruiting
Myocardial Stiffness Evaluation in Patients With Heart Failure With Preserved Ejection Fraction Recruiting
Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction Starting soon
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06391710 on ClinicalTrials.gov ↗ ← All trials in China