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 range18 Years – 80 Years
SexALL
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.
✓. 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.
. 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.