NCT06391710

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	HRS9531	subcutaneous
DRUG	Placebo	subcutaneous

Timeline

• Start date: 2024-05-06
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-04-30
• Last updated: 2025-11-24

Locations

1 site across 1 country: China