A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hyp… (NCT07421232) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
China156 participantsStarted 2024-12-03
Plain-language summary
The purpose of this study is to compare the effectiveness, safety of SYH2053 in Participants with primary hypercholesterolemia or mixed dyslipidemia.
A total of 156 Participants were actually enrolled
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age of 18 - 75 years (inclusive);
. Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained a low-fat diet for at least 4 weeks prior to screening. Additionally, meet one of the following criteria:
. According to local laboratory results, low-density lipoprotein cholesterol (LDL-C) level ≥100 mg/dL(2.6 mmol/L) and fasting triglycerides ≤400 mg/dL (4.5 mmol/L);
. Participants must understand of the study protocol, including the nature of the intervention and potential adverse events, and must provide voluntary, written informed consent before enrollment;
. Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.
Exclusion criteria
. Participants with severe allergic diseases or an allergic constitution (allergies to three or more drugs or foods) or allergic to oligonucleotide drugs；
. History of treatment with PCSK9-targeted antibody therapies or PCSK9-targeted oligonucleotide therapies;
. History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg during the Screening Period or prior to Randomization (repeat measurement allowed once);
. History of severe cardiovascular or cerebrovascular disease (e.g., hypertensive encephalopathy, acute stroke, transient ischemic attack, acute myocardial infarction, severe arrhythmia, etc.) within 6 months prior to Screening or prior to Randomization; or presence of severe aortic or peripheral vascular disease; or presence of conditions requiring surgical intervention; history of major surgery within 6 months prior to Screening or prior to Randomization; or plans for major surgery during the study period;
. History of heart failure with NYHA Class III-IV, or LVEF \< 40% at Screening Period;
. eGFR \< 30 mL/min/1.73 m² at Screening Period;
. Presence of severe thyroid disease (except for subjects on a stable dose of thyroid hormone replacement therapy or anti-thyroid medication for at least 6 months prior to Screening or Randomization);