KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorMikko Niemi

About this trial

A majority of high-risk patients does not achieve their cholesterol target levels and most of these patients do not receive more effective combination therapy, which goes beyond statin monotherapy. Large interindividual differences in treatment outcomes have been observed for patients receiving statins. Statins block cholesterol synthesis and increase cellular low-density lipoprotein (LDL) uptake. Importantly, LDL uptake is highly divergent in individuals.The aim of this trial is to investigate how atorvastatin influences leukocyte readouts of LDL uptake and lipid storage in humans. The trial is a single-arm, open-label, interventional trial. A total of 15 healthy volunteers will receive 40 mg atorvastatin once a day for 4 weeks. The participants will provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin, and one week after the end of the intervention for the measurement of leukocyte readouts of LDL uptake and lipid storage.

Eligibility criteria

Qualifiers

a signed written informed consent

age 18-40 years

healthy, and

Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.

Disqualifiers

significant disease

smoking

SLCO1B1 poor function genotype

oral contraception or other continuous medication

Trial design

Treatments tested in this trial

  • Atorvastatin

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mikko Niemi

Lead sponsor

Helsinki University Central Hospital

Sponsor institution

University of Helsinki

Collaborator