Evaluate the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia (NCT04948008) | Clinical Trial Compass
UnknownPhase 2/3
Evaluate the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia
China8 participantsStarted 2019-11-05
Plain-language summary
IBI306 is a bio-innovative drug against proprotein convertase subtilisin 9 (PCSK-9) monoclonal antibody. Currently, cholesterol-lowering drugs with multiple mechanisms of action are on the market or under development. Among them, anti-PCSK-9 monoclonal antibodies have received widespread attention due to their good safety and efficacy. The results of existing preclinical studies show that IBI306 has a clear structure, good stability, and is not inferior to other drugs of its kind in terms of drug activity, animal pharmacokinetics (PK)/pharmacodynamics (PD) and safety.
This study is divided into two phases: the dose exploration phase (the first phase) and the confirmatory phase (the second phase). Each stage is divided into screening period, treatment period, and safety follow-up period. The first phase of this research is the randomized design of open labels. The second stage is an open, single-arm design.
The main purpose of the first phase of the study: to evaluate the tolerability and safety of multiple-dose repeated administration of IBI306 in the Chinese population with hypercholesterolemia, and to recommend the dose for the second phase. The main purpose of the second phase of the study: to evaluate the effectiveness of IBI306 in the Chinese homozygous familial hypercholesterolemia population. Secondary research purpose: To evaluate the safety and immunogenicity of IBI306 in Chinese homozygous familial hypercholesterolemia population.
Who can participate
Age range
18 Years – 80 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
. Provide a signed and dated informed consent form.
. Men or women aged ≥18 and ≤80 at the time of screening.
. Weight ≥40 kg at the time of screening.
. Meet at least one of genetic testing confirmation or clinical data to diagnose homozygous familial hypercholesterolemia.
. Maintain a low-fat diet and stably take the current lipid-lowering therapy (taking moderate-strength statins, except for statin intolerance, with or without ezetimibe, bile acid chelator, or niacin) for at least 4 weeks.
. The fasting LDL cholesterol concentration of the local laboratory at the time of screening was ≥3.4 mmol/L.
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.
. Fasting triglycerides ≤4.5 mmol/L during screening by the local laboratory.
. The subjects indicated their willingness and cooperation to complete all the steps in the research and the research intervention period.
Exclusion criteria
. Dialysis or plasma exchange was performed within 8 weeks before screening.
. Patients who have received liver transplant surgery in the past.
. Have used Mipomethamine or Lometapide within 5 months before screening.
. Subjects should adjust their current lipid-lowering drug regimen or doses such as statins within 4 weeks before screening (these subjects can stabilize the current dose of lipid-lowering drugs such as statins and can be re-screened for 1 month).
. There are uncontrolled clinical diseases that may affect blood lipids or lipoprotein levels (for patients with thyroid hormone replacement therapy, the thyroid hormone dose needs to be stabilized for at least 6 weeks before the screening visit)
. New York Heart Association (NYHA) grade III or IV heart failure, or recently detected left ventricular ejection fraction \<30%.
. Uncontrolled severe arrhythmia, defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response or supraventricular tachycardia.
. Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting or stroke occurred within 3 months before enrollment.