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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Zhou Li
zhou.li.zl69@hengrui.com
+86 17721288193
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2026-01
Participants
Target number of participants: 200
Treatments
Experimental: HRS9531
Placebo_comparator: Placebo
Sponsors
Leads: Fujian Shengdi Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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