Heart Failure With Preserved Ejection FractionPhase 2NCT06391710
HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing HRS9531 in people with Heart Failure With Preserved Ejection Fraction, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- HRS9531
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
About this study
Official title: 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
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.
- Being tested
- HRS9531, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531Drug
subcutaneous
PlaceboDrug
subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| HRS9531 | Experimental | Not described Receives: Drug: HRS9531 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Measured: From baseline (week 0) to week 36
Change in body weight
Measured: From baseline (week 0) to week 36
Secondary outcomes (8)
Hierarchical composite of time to all-cause death
Measured: From baseline (week 0) to week 36,52
Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit
Measured: 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
Measured: 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
Measured: From baseline (week 0) to week 36,52
Change in KCCQ clinical summary score
Measured: From baseline (week 0) to week 52
Change in body weight
Measured: From baseline (week 0) to week 52
Change in C-Reactive Protein (CRP)
Measured: From baseline (week 0) to week 36,52
Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)
Measured: From baseline (week 0) to week 36,52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start6 May 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391710
- Sponsor's protocol ID
- HRS9531-205
- Status last verified
- Nov 2025
- First submitted
- 25 Apr 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06391710
- Acronym / sponsor ID
- HRS9531-205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS9531 | Experimental | Drug: HRS9531 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS9531subcutaneous | Drug | HRS9531 |
| Placebosubcutaneous | Drug | Placebo |
Primary outcome
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score
Time frame: From baseline (week 0) to week 36
Change in body weight
Time frame: From baseline (week 0) to week 36
8 secondary outcomes
Hierarchical composite of time to all-cause death
Time frame: From baseline (week 0) to week 36,52
Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit
Time frame: 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
Time frame: 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
Time frame: From baseline (week 0) to week 36,52
Change in KCCQ clinical summary score
Time frame: From baseline (week 0) to week 52
Change in body weight
Time frame: From baseline (week 0) to week 52
Change in C-Reactive Protein (CRP)
Time frame: From baseline (week 0) to week 36,52
Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP)
Time frame: From baseline (week 0) to week 36,52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS9531 in people with Heart Failure With Preserved Ejection Fraction, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score (time frame: From baseline (week 0) to week 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.