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

NCT ID: NCT06391710

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-06

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HRS9531

Group Type EXPERIMENTAL

HRS9531

Intervention Type DRUG

subcutaneous

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

subcutaneous

Interventions

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HRS9531

subcutaneous

Intervention Type DRUG

Placebo

subcutaneous

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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HRS9531-205

Identifier Type: -

Identifier Source: org_study_id

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