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

NCT06391710 | Active Not Recruiting Phase 2

• 1 other identifier: HRS9531-205
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Hierarchical composite of time to all-cause death

  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 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 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

Study Arms (2)

HRS9531

EXPERIMENTAL

Drug: HRS9531

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS9531 DRUG

subcutaneous

HRS9531

Placebo DRUG

subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: May 6, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (1)