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New treatment option for Mixed Hyperlipidemia
Official title A Study of SYH2070 Injection in Participants With Mixed Hyperlipidemia
ClinicalTrials.gov ID: NCT07695597
What this study is testing
What is SYH2070?
SYH2070 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for mixed hyperlipidemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years old, no gender limitation;
- 1.7 mmol/L (150 mg/dL) ≤ fasting TG ≤ 5.6 mmol/L (499 mg/dL) at screening;
- 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...
- Weight index range: 18.5 kg/m2 ≤ BMI ≤ 40.0 kg/m2 at screening;
You likely can't join if
- Genetic diagnosis or clinical diagnosis indicates homozygous familial hypercholesterolemia;
- 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...
- Within 3 months before the screening, there are clinically significant arrhythmias, such as recurrent and symptomatic ventricular tachycardia, atrial...
- 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);
See the full eligibility criteria
Who can join
- Age ≥ 18 years old, no gender limitation;
- 1.7 mmol/L (150 mg/dL) ≤ fasting TG ≤ 5.6 mmol/L (499 mg/dL) at screening;
- 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...
- 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...
What rules you out
- Genetic diagnosis or clinical diagnosis indicates homozygous familial hypercholesterolemia;
- 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...
- 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...
- 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 ;
- Within 1 year before the screening, there is a history of acute or chronic pancreatitis;
- Within 5 years before the screening, there is a history of malignant tumor (excluding well-treated basal cell skin cancer and cervical carcinoma in situ);
- Within 3 months before the screening, there is a history of major surgery (including coronary artery bypass grafting surgery) or planned major surgery during the trial;
- Plan to undergo percutaneous coronary intervention, coronary artery bypass grafting, carotid or peripheral artery revascularization, pacemaker implantation, cardiac resynchronization therapy, implantation of implantable...
- At the time of screening or before randomization, there is an active infectious disease that the investigator deems not suitable for participation in the trial;
- Previously had a history of drug abuse, alcohol abuse, or drug addiction;
- Known to be allergic to the test drugs or have a severe allergic reaction to other small nucleic acid drugs;
- Within 6 months before the screening has used other ANGPTL3 inhibitor lipid-lowering drugs;
- Within 3 months before the screening has used PCSK9 monoclonal antibody lipid-lowering drugs;
- Within 1 year before the screening has used other siRNA lipid-lowering drugs;
- Within 2 months before the screening has received or plans to receive plasma exchange treatment;
- Within 3 months before the screening has used drugs with weight loss effects or undergone surgeries that cause unstable weight;
- Within 3 months before the screening has long-term continuous or repeated use of cyclosporine, systemic corticosteroids (excluding local use, such as intra-articular, nasal, inhalation, topical use, etc.; long-term...
- Within 3 months before the screening has participated in any clinical trial (excluding those who failed the screening), or is within 5 half-lives of the trial drug at the time of screening, with the longer time being...
- Any of the indicators meet the following criteria: 1) Alanine aminotransferase or aspartate aminotransferase or γ-glutamyl transferase exceeds 2.0 times the upper limit of normal (ULN), or total bilirubin exceeds 1.5...
- Researchers evaluate those whose lifestyle has undergone significant changes within the previous 4 weeks, or those who cannot maintain it during the trial;
- Researchers determine that they are not suitable for subcutaneous injection;
- Pregnant or lactating women;
- Researchers judge that the participants have poor compliance or any factors that are not suitable for participating in this trial, including but not limited to participating in the trial would expose the participants to...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.