A Study of SYH2070 Injection in Participants With Mixed Hyperlipidemia (NCT07695597) | Clinical Trial Compass
RecruitingPhase 2
A Study of SYH2070 Injection in Participants With Mixed Hyperlipidemia
China240 participantsStarted 2026-07-15
Plain-language summary
This is a randomized, double-blind, placebo-parallel, multicenter phase II clinical trial to evaluate the efficacy and safety of SYH2070 injection in participants with mixed hyperlipidemia.
Who can participate
Age range
18 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.
. fasting LDL-C ≥ 2.6 mmol/L (100 mg/dL) at screening;
. Participants must have been continuously taking stable medium-intensity or higher statin drugs for at least 4 weeks, accompanied or not by cholesterol absorption inhibitors or fibrates, and maintain the same drug, dosage, frequency and brand throughout the trial period;
. Weight index range: 18.5 kg/m2 ≤ BMI ≤ 40.0 kg/m2 at screening;
. Understand the trial procedures and methods, voluntarily participate in this trial and sign the ICF in person;
. Male participants with reproductive capacity and their partners who are reproductive-aged women must agree to use highly effective contraceptive measures during the trial period and 24 weeks after the last administration of the trial drug; serum pregnancy tests before medication, serum or urine pregnancy tests during the trial period must be negative, and not be in the lactation period; participants are not allowed to donate sperm or eggs during the trial period and 24 weeks after the last administration of the trial drug.
Exclusion criteria
. Genetic diagnosis or clinical diagnosis indicates homozygous familial hypercholesterolemia;
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.
What they're measuring
1
The percentage change in serum TG levels from baseline at week 24
. During the screening or before randomization, there is NYHA-defined heart function grade Ⅲ-Ⅳ or known left ventricular ejection fraction \< 30%;
. Within 3 months before the screening, there has been a new major cardiovascular adverse event, including acute coronary syndrome (such as myocardial infarction, unstable angina pectoris), cerebrovascular disease history (such as acute stroke or transient ischemic attack), or acute pulmonary embolism;
. Within 3 months before the screening, there are clinically significant arrhythmias, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, atrial flutter with rapid ventricular rate, third-degree atrioventricular block, sinus arrest, etc.), drug or ablation-induced arrhythmias that cannot be controlled;
. Within 1 month before the screening, there is a history of percutaneous coronary intervention or peripheral artery revascularization surgery;
. At screening, there is poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
. Previously diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc.;
. Previously diagnosed with type 1 diabetes, or type 2 diabetes HbA1c \> 8.5% at screening ;