May 9, 2026Journal of Atherosclerosis and Thrombosis1 citationsOpen Access

A Phase 1 Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Zerlasiran in Japanese Participants

Q: What is the clinical evidence from this study?

Study design: Other. Population: Elevated lipoprotein(a) (n=18). Intervention: Zerlasiran. Primary outcome: Maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), apparent plasma terminal elimination half-life (t1/2), and area under the plasma concentration-time curve (AUC).

HFHenry Fok MHMariko Harada-Shiba DRDavid Rider

Key Result

A single subcutaneous dose of zerlasiran was well tolerated and produced a dose-dependent, sustained reduction in lipoprotein(a) of up to 97.8% over 150 days in Japanese participants.

Key Points

This study aims to evaluate the pharmacokinetics, pharmacodynamics, and safety of zerlasiran in Japanese participants.
Phase 1 study design
Evaluated pharmacokinetics and pharmacodynamics
Focus on safety among Japanese participants
Zerlasiran effectively targets lipoprotein(a) levels
Demonstrated safety profile consistent with prior findings
Potential implications for reducing cardiovascular risk in this population

Structured PICO

Does a single subcutaneous dose of zerlasiran safely reduce lipoprotein(a) levels in Japanese adults with elevated lipoprotein(a)?

Population

18 adults of Japanese heritage (aged 20-70 years) with serum lipoprotein(a) ≥ 70 nmol/L and body mass index between 18 and 32 kg/m2. Mean age 49.6 years, 50% female. Key exclusions: history of clinically overt ASCVD, type 1 diabetes mellitus, poorly controlled type 2 diabetes mellitus, estimated GFR <60 mL/min/1.73 m2, moderate or severe liver cirrhosis.

Intervention

Single subcutaneous dose of zerlasiran (30 mg, 100 mg, or 300 mg) administered at a single injection site in the abdomen.

Outcome

Evaluation of maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), apparent plasma terminal elimination half-life (t1/2), and exposure parameters by area under the plasma concentration–time curve (AUC).surrogate

Limitations

Immunogenicity of zerlasiran was not tested in this single-dose study
Small sample size
Open-label design without a placebo control

Abstract

Aim: Zerlasiran is an N-acetylgalactosamine-conjugated small interfering RNA that targets lipoprotein(a), a risk factor for atherosclerosis and calcific aortic stenosis. Zerlasiran has not been studied in Japanese participants previously.

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Cite This Study

Fok et al. (Thu,) conducted a other in Elevated lipoprotein(a) (n=18). Zerlasiran was evaluated on Maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), apparent plasma terminal elimination half-life (t1/2), and area under the plasma concentration-time curve (AUC). A single subcutaneous dose of zerlasiran was well tolerated and produced a dose-dependent, sustained reduction in lipoprotein(a) of up to 97.8% over 150 days in Japanese participants.

synapsesocial.com/papers/69fed03cb9154b0b82877489 https://doi.org/https://doi.org/10.5551/jat.66214