Safety and Efficacy of IBI306 in HeFH Patients (NCT04179669) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of IBI306 in HeFH Patients
China149 participantsStarted 2019-12-20
Plain-language summary
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol (LDL-C) uptake. In the phase I study, IBI306 was shown to be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects. This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous familial hypercholesterolemia.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
• Subjects must meet all of the following inclusion criteria in order to be included in the study:
* Provide a signed and dated informed consent form
* Men or women 18 to 70 years of age at screening
* Weight ≥ 40 kg during screening
* Confirmed diagnosis of heterozygous familial hypercholesterolemia
* Maintain a low-fat diet and stabilize the current lipid-lowering therapy
Exclusion Criteria:
• Subjects who do not meet any of the following exclusion criteria cannot be included in the study:
* Patients diagnosed as homozygous familial hypercholesterolemia
* Dialysis or plasmapheresis performed within 4 months prior to screening
* History of liver transplant
* Subjects adjusted for treatment of statins, ezetimibe, niacin, omega-fatty acids within 4 weeks prior to screening
* New York Heart Association (NYHA) grade III or IV heart failure, or recent detection of left ventricular ejection fraction ≤ 30%
* Have serious cardiovascular, cerebrovascular, liver and kidney related diseases
What they're measuring
1
Percentage of LDL-C decreased from baseline injection.