Lead Sponsor

Akeso

Collaborators

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Males and females, ≥18 years of age with a diagnosis of homozygous familial hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a history of an untreated low-density lipoprotein cholesterol (LDL-C) concentration \>500 mg/deciliter (dL) \[13 millimoles/liter (mmol/L)\] together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents
•Stable on pre-existing, lipid-lowering therapies (statins in combination with ezetimibe) for at least 4 weeks with no planned medication or dose change for the duration of study participation
•Fasting central lab LDL-C concentration \>130 mg/dL (3.4 mmol/L) and triglyceride concentration \<400 mg/dL (4.5 mmol/L).
•Body weight of 40 kilograms (kg) or greater at screening

•Received LDL plasma replacement therapy within 8 weeks before Investigational product administration
•Received Lomitapide or Mipomersen within 5 months before Investigational product administration
•Received prior treatment with PCSK9 inhibitors or AK102.
•Unexplained creatine kinase (CK) ≥ 5 times the upper limit of normal (ULN)
•Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA \<500 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
•Known allergic reactions to any ingredients of AK102
•Any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study as judged by the Investigator and/or Medical Monitor.

Related studies

NCT07037771 · Homozygous Familial Hypercholesterolemia

NCT07489209 · Homozygous Familial Hypercholesterolemia (HoFH)

NCT01109368 · Homozygous Familial Hypercholesterolemia

NCT06832371 · Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE), and more

NCT06723652 · Homozygous Familial Hypercholesterolemia

A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH