Atherosclerotic Cardiovascular Disease
Conditions
Brief 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.
Interventions
DRUGHRS9531
HRS9531 Dose 1 , subcutaneous injection
DRUGHRS9531 placebo
HRS9531 placebo Dose 1, subcutaneous injection
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with atherosclerotic cardiovascular disease (ASCVD) 2. 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
Exclusion criteria
1. 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 2. Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening 3. When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers 4. Coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, and carotid or peripheral artery recanalization are planned to be performed during the trial 5. Those with a history of acute or chronic pancreatitis, acute cholecystitis, or symptomatic or treatment-requiring gallbladder diseases 6. 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 7. Pregnant or lactating women, or participants with fertility who are unwilling to take effective contraceptive measures 8. Those who have had any previous conditions that affected gastric emptying or have undergone gastrointestinal surgery 9. Diagnosed or suspected as type 1 diabetes, special type diabetes or secondary diabetes 10. Acute complications of diabetes occurred within one month before screening 11. There are endocrine diseases that may significantly affect weight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time from randomization to the first occurrence of the MACE-3 composite endpoint | approximately up to 61 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Time to the first occurrence of the MACE-4 composite endpoint | approximately up to 61 months of treatment |
| Time to the first occurrence of the extended MACE composite endpoint | approximately up to 61 months of treatment |
| Time to the first occurrence of the composite endpoint of heart failure； | approximately up to 61 months of treatment |
| Time to the first occurrence of the composite endpoint of kidney disease； | approximately up to 61 months of treatment |
| Time to the first occurrence of the composite endpoint of major adverse limb events； | approximately up to 61 months of treatment； |
| Time when each component event of the MACE-3 composite endpoint occurred for the first time | approximately up to 61 months of treatment； |
| Time when all-cause death occurs； | approximately up to 61 months of treatment； |
| Time to the first hospitalization due to heart failure； | approximately up to 61 months of treatment； |
| Time to the first emergency heart failure visit； | approximately up to 61 months of treatment； |
| Time when the first persistent eGFR decreased by ≥50% from baseline； | approximately up to 61 months of treatment； |
| Time when persistent eGFR < 15 mL/min/1.73m2 occurred for the first time； | approximately up to 61 months of treatment； |
| Time to first entering chronic renal replacement therapy (dialysis or kidney transplantation) ； | approximately up to 61 months of treatment； |
| The time when renal death occurs； | approximately up to 61 months of treatment； |
| Time to hospitalization for the first occurrence of acute limb ischemia； | approximately up to 61 months of treatment； |
| Time to hospitalization for the first occurrence of unplanned chronic limb ischemia； | approximately up to 61 months of treatment |
| Incidence and severity of adverse events ; | Approximately 61 months |
| Change from baseline in body weight; | From randomization to 104 weeks |
| Change from baseline in waistline; | From randomization to 104 weeks |
| Change from baseline in glycosylated hemoglobin; | From randomization to 104 weeks |
| Change from baseline in blood lipid parameter; | From randomization to 104 weeks |
| Change from baseline in blood pressure; | From randomization to 104 weeks |
| Change from baseline in glomerular filtration; | From randomization to 104 weeks |
| Change from baseline in Uric Acid; | From randomization to 104 weeks |
| Change from baseline in hsCRP; | From randomization to 104 weeks |
| The time to the first unplanned revascularization event | approximately up to 61 months of treatment； |
| Time when the first persistent eGFR decreased by ≥40% from baseline； | approximately up to 61 months of treatment |
Countries
China
Contacts
CONTACTSheng Qi
PRINCIPAL_INVESTIGATORKefei Dou
Chinese Academy of Medical Sciences, Fuwai Hospital
STUDY_DIRECTORXiao Wang
Chinese Academy of Medical Sciences, Fuwai Hospital
Outcome results
None listed