A Study to Evaluate Safety and Efficacy of IBI306 in Patients With Heterozygous Familial Hypercholesterolemia

CIBI306C301

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.

2019-12-20

2021-06-30

2021-06-30

Completed

Early phase I

149

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

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2023-08-09