PCSK9 synthesis inhibitor

Inclisiran is a PCSK9 synthesis inhibitor that lowers LDL-C. The subcutaneous treatment lowers LDL-C by 50% in patients with ASCVD who have already been treated with statins. In patients with heterozygous familial hypercholesterolemia, the difference in LDL-C compared to the placebo group was approximately 40%. There was no increase in the rate of side effects.

Outcomes trial

Current Status (as of 2025):
The ongoing ORION-4 study is the most important outcomes trial for Inclisiran.

It is investigating whether Inclisiran reduces the risk of cardiovascular events in patients with existing atherosclerotic cardiovascular disease (ASCVD).

Primary endpoint: Time to first cardiovascular event (heart attack, stroke, or cardiovascular death).

Study status:
Recruitment has been completed, and the first results are expected to be published in 2026.

Conclusion:
So far, data on Inclisiran mainly show a strong LDL-C-lowering effect with good tolerability. The clinical benefit in terms of preventing cardiovascular events is still being evaluated in outcome studies such as ORION-4. Until these results are published, the direct cardiovascular benefit remains not yet fully established.