Recruiting NCT07551492
A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS9531, HRS9531 placebo.
- Who it may be relevant to
- Registry conditions: Atherosclerotic Cardiovascular Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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
- Drug HRS9531
HRS9531 Dose 1 , subcutaneous injection - Drug HRS9531 placebo
HRS9531 placebo Dose 1, subcutaneous injection
Primary outcome measures
- The time from randomization to the first occurrence of the MACE-3 composite endpoint [Time frame: approximately up to 61 months of treatment]
Secondary outcome measures (12)
- 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；]
Eligibility criteria
Inclusion criteria
- Diagnosed with atherosclerotic cardiovascular disease (ASCVD), and the course of the disease exceeds 3 months
- 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
- 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, and intermittent claudication
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fuwai Hospital, CAMS&PUMC — Beijing
Identifiers
NCT: NCT07551492 · HRS9531-310