Zhibitai Capsules for the Treatment of Primary Hyperlipidemia (NCT06822946) | Clinical Trial Compass
RecruitingPhase 2
Zhibitai Capsules for the Treatment of Primary Hyperlipidemia
China192 participantsStarted 2025-03-27
Plain-language summary
Exploring the benefit risk ratio of increase in dosage of Zhibitai capsules (2 capsules at a time, 2 times a day) compared to the original dosage (1 capsule at a time, 1 day)
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 between 18 and 75 years old (inclusive), regardless of gender;
. BMI (Body Mass Index) between 18.0 kg/m² and 30.0 kg/m²;
. Meets the diagnostic criteria for primary hyperlipidemia (tan yu hu jie, qi xue bu li zheng);
. Diagnosis before and after the run-in period meets the above criteria, and the absolute difference between the two LDL-C measurements before and after the run-in period does not exceed 12%;
. Agrees to follow dietary and lifestyle modification guidance during the trial, maintain a stable diet and exercise routine throughout the study, take medication as required, and complete diary cards;
. Agrees to participate in this clinical trial and voluntarily signs the informed consent form.
Exclusion criteria
. Known or suspected allergy to any component of the investigational product, or having an allergic constitution.
. According to the "Chinese Guidelines for Lipid Management (2023)", individuals classified as being at very high risk or extremely high risk for ASCVD.
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 and absolute changes in serum low-density lipoprotein cholesterol (LDL-C) from baseline after 4, 8, and 12 weeks of treatment
Timeframe: From enrollment to the end of treatment at 4, 8,12 weeks
. Dyslipidemia caused by secondary reasons, such as nephrotic syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen storage disease, myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome, drug-induced causes (e.g., phenothiazines, beta-blockers, glucocorticoids, certain contraceptives, etc.), or patients currently using heparin, thyroid hormone therapy, or other medications that affect lipid metabolism.
. Any surgical or medical condition that may significantly affect the absorption, distribution, metabolism, or excretion of the drug:
. Previous use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, such as evolocumab and alirocumab.
. Use of lipid-lowering drugs within 4 weeks prior to enrollment or within 5 half-lives of the drug (whichever is longer), such as statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, niacin, high-purity fish oil preparations, weight-loss drugs (e.g., GLP-1 receptor agonists), and other traditional Chinese medicines, health products, or hospital preparations (e.g., formula granules, herbal decoctions) with clear lipid-lowering effects as stated in the instructions.
. History of acute or chronic liver disease, drug-induced liver injury, or cirrhosis (except for mild fatty liver indicated by abdominal ultrasound).