Atherosclerotic Cardiovascular DiseasePhase 3NCT07551492
A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
A Phase 3 study testing HRS9531 in people with Atherosclerotic Cardiovascular Disease, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- 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
- 9,262 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2026to 28 Jun 2031
- Phase
- Phase 3
- 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
- Diagnosed with atherosclerotic cardiovascular disease (ASCVD)
- The body mass index (BMI) at the time of screening was ≥24.0 kg/m ². Patients with type 2 diabetes have a BMI of ≥22.0 kg/m ²
Who cannot join
- Screening for myocardial infarction, acute decompensated heart failure, hospitalization due to heart failure, unstable angina pectoris, stroke or transient ischemic attack, coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, carotid or peripheral artery recanalization within 30 days prior to the screening
- Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening
- When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers
- Coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, and carotid or peripheral artery recanalization are planned to be performed during the trial
- Those with a history of acute or chronic pancreatitis, acute cholecystitis, or symptomatic or treatment-requiring gallbladder diseases
- Any malignant tumor of the organ system has occurred within the past five years, regardless of whether there is evidence of local recurrence or metastasis, except for cured local cutaneous basal cell carcinoma and cervical carcinoma in situ
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- Pregnant or lactating women, or participants with fertility who are unwilling to take effective contraceptive measures
- Those who have had any previous conditions that affected gastric emptying or have undergone gastrointestinal surgery
- Diagnosed or suspected as type 1 diabetes, special type diabetes or secondary diabetes
- Acute complications of diabetes occurred within one month before screening
- There are endocrine diseases that may significantly affect weight
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
Kefei Dou
Xiao Wang
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Participants With Atherosclerotic Cardiovascular Disease (ASCVD)
The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- HRS9531, HRS9531 placebo
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531Drug
HRS9531 Dose 1 , subcutaneous injection
HRS9531 placeboDrug
HRS9531 placebo Dose 1, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| HRS9531 Group A | Experimental | Not described Receives: Drug: HRS9531 |
| HRS9531 placebo Group B | Placebo comparator | Not described Receives: Drug: HRS9531 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time from randomization to the first occurrence of the MACE-3 composite endpoint
Measured: approximately up to 61 months of treatment
Secondary outcomes (26)
Time to the first occurrence of the MACE-4 composite endpoint
Measured: approximately up to 61 months of treatment
Time to the first occurrence of the extended MACE composite endpoint
Measured: approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of heart failure；
Measured: approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of kidney disease；
Measured: approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of major adverse limb events；
Measured: approximately up to 61 months of treatment；
Time when each component event of the MACE-3 composite endpoint occurred for the first time
Measured: approximately up to 61 months of treatment；
Time when all-cause death occurs；
Measured: approximately up to 61 months of treatment；
Time to the first hospitalization due to heart failure；
Measured: approximately up to 61 months of treatment；
Time to the first emergency heart failure visit；
Measured: approximately up to 61 months of treatment；
Time when the first persistent eGFR decreased by ≥50% from baseline；
Measured: approximately up to 61 months of treatment；
Time when persistent eGFR < 15 mL/min/1.73m2 occurred for the first time；
Measured: approximately up to 61 months of treatment；
Time to first entering chronic renal replacement therapy (dialysis or kidney transplantation) ；
Measured: approximately up to 61 months of treatment；
The time when renal death occurs；
Measured: approximately up to 61 months of treatment；
Time to hospitalization for the first occurrence of acute limb ischemia；
Measured: approximately up to 61 months of treatment；
Time to hospitalization for the first occurrence of unplanned chronic limb ischemia；
Measured: approximately up to 61 months of treatment
Incidence and severity of adverse events ;
Measured: Approximately 61 months
Change from baseline in body weight;
Measured: From randomization to 104 weeks
Change from baseline in waistline;
Measured: From randomization to 104 weeks
Change from baseline in glycosylated hemoglobin;
Measured: From randomization to 104 weeks
Change from baseline in blood lipid parameter;
Measured: From randomization to 104 weeks
Change from baseline in blood pressure;
Measured: From randomization to 104 weeks
Change from baseline in glomerular filtration;
Measured: From randomization to 104 weeks
Change from baseline in Uric Acid;
Measured: From randomization to 104 weeks
Change from baseline in hsCRP;
Measured: From randomization to 104 weeks
The time to the first unplanned revascularization event
Measured: approximately up to 61 months of treatment；
Time when the first persistent eGFR decreased by ≥40% from baseline；
Measured: approximately up to 61 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start29 May 2026
- Primary completion24 May 2031 (estimated)
- Study completion28 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9,262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kefei Dou, Principal investigator, Chinese Academy of Medical Sciences, Fuwai HospitalXiao Wang, Study director, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551492
- Sponsor's protocol ID
- HRS9531-310
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 8 Sep 2026
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Participants With Atherosclerotic Cardiovascular Disease (ASCVD)
- ClinicalTrials.gov ID
- NCT07551492
- Acronym / sponsor ID
- HRS9531-310
- Conditions
- Atherosclerotic Cardiovascular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9,262 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 24 May 2031 (estimated)
- Study completion
- 28 Jun 2031 (estimated)
- First posted
- 24 Apr 2026 (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.
The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.
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 Group A | Experimental | Drug: HRS9531 |
| HRS9531 placebo Group B | Placebo comparator | Drug: HRS9531 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with atherosclerotic cardiovascular disease (ASCVD)
- The body mass index (BMI) at the time of screening was ≥24.0 kg/m ². Patients with type 2 diabetes have a BMI of ≥22.0 kg/m ²
Key exclusion criteria (11 listed)
- Screening for myocardial infarction, acute decompensated heart failure, hospitalization due to heart failure, unstable angina pectoris, stroke or transient ischemic attack, coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, carotid or peripheral artery recanalization within 30 days prior to the screening
- Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening
- When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers
- Coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, and carotid or peripheral artery recanalization are planned to be performed during the trial
- Those with a history of acute or chronic pancreatitis, acute cholecystitis, or symptomatic or treatment-requiring gallbladder diseases
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 |
|---|---|---|
| HRS9531HRS9531 Dose 1 , subcutaneous injection | Drug | HRS9531 Group A |
| HRS9531 placeboHRS9531 placebo Dose 1, subcutaneous injection | Drug | HRS9531 placebo Group B |
Primary outcome
The time from randomization to the first occurrence of the MACE-3 composite endpoint
Time frame: approximately up to 61 months of treatment
26 secondary outcomes
Time to the first occurrence of the MACE-4 composite endpoint
Time frame: approximately up to 61 months of treatment
Time to the first occurrence of the extended MACE composite endpoint
Time frame: approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of heart failure；
Time frame: approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of kidney disease；
Time frame: approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of major adverse limb events；
Time frame: approximately up to 61 months of treatment；
Time when each component event of the MACE-3 composite endpoint occurred for the first time
Time frame: approximately up to 61 months of treatment；
Time when all-cause death occurs；
Time frame: approximately up to 61 months of treatment；
Time to the first hospitalization due to heart failure；
Time frame: approximately up to 61 months of treatment；
Time to the first emergency heart failure visit；
Time frame: approximately up to 61 months of treatment；
Time when the first persistent eGFR decreased by ≥50% from baseline；
Time frame: approximately up to 61 months of treatment；
Time when persistent eGFR < 15 mL/min/1.73m2 occurred for the first time；
Time frame: approximately up to 61 months of treatment；
Time to first entering chronic renal replacement therapy (dialysis or kidney transplantation) ；
Time frame: approximately up to 61 months of treatment；
The time when renal death occurs；
Time frame: approximately up to 61 months of treatment；
Time to hospitalization for the first occurrence of acute limb ischemia；
Time frame: approximately up to 61 months of treatment；
Time to hospitalization for the first occurrence of unplanned chronic limb ischemia；
Time frame: approximately up to 61 months of treatment
Incidence and severity of adverse events ;
Time frame: Approximately 61 months
Change from baseline in body weight;
Time frame: From randomization to 104 weeks
Change from baseline in waistline;
Time frame: From randomization to 104 weeks
Change from baseline in glycosylated hemoglobin;
Time frame: From randomization to 104 weeks
Change from baseline in blood lipid parameter;
Time frame: From randomization to 104 weeks
Change from baseline in blood pressure;
Time frame: From randomization to 104 weeks
Change from baseline in glomerular filtration;
Time frame: From randomization to 104 weeks
Change from baseline in Uric Acid;
Time frame: From randomization to 104 weeks
Change from baseline in hsCRP;
Time frame: From randomization to 104 weeks
The time to the first unplanned revascularization event
Time frame: approximately up to 61 months of treatment；
Time when the first persistent eGFR decreased by ≥40% from baseline；
Time frame: approximately up to 61 months of treatment
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 8 Sep 2026.
- 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.
Kefei Dou principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Xiao Wang study director
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS9531 in people with Atherosclerotic Cardiovascular Disease, 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 2 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Sheng Qi (+8613482562074, Sheng.qi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time from randomization to the first occurrence of the MACE-3 composite endpoint (time frame: approximately up to 61 months of treatment). 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 8 Sep 2026.