Zhao · American journal of human genetics 2006 · In vitro molecular study and single-case genetic/clinical report · n=1

Molecular characterization of loss-of-function mutations in PCSK9 and identification of a compound heterozygote.

Cited 633 times in the scientific literature.

Level 4 - case-series / case-control

In vitro mechanistic characterization combined with a single human case report

PubMed 16909389 · doi:10.1086/507488 · record verified 2026-08-30

What was done

Investigated the cellular mechanisms of four PCSK9 loss-of-function mutations by assessing protein synthesis, trafficking, and secretion kinetics in vitro relative to wild-type PCSK9. Analyzed human plasma via immunoprecipitation and immunoblotting to measure circulating PCSK9 and lipid profiles in individuals with inactivating mutations.

What was found

Recombinant wild-type PCSK9 was secreted from cells into culture medium within 2 hours, whereas the four loss-of-function mutations largely abolished PCSK9 secretion. A compound heterozygote for two inactivating mutations had no immunodetectable circulating PCSK9, had an LDL-C level of 14 mg/dL, and was reported as healthy and fertile.

Why it matters

Provides direct human genetic and mechanistic proof that complete absence of circulating PCSK9 causes extremely low LDL-C without overt adverse effects, establishing PCSK9 as a viable target for cholesterol-lowering therapeutics.

Limits

Clinical and safety observations rely on a single human case (n = 1). The abstract does not report broader cardiovascular outcomes or quantitative safety parameters beyond apparent good health and fertility.

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