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RecruitingCholesterol; Lipidosis

Liver Adiposity Effects on Pediatric Statin

Eligible age

8–21 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

Single center, open-label, prospective investigation to quantify the effects hepatocellular fat has on hepatic statin transport and response in children and adolescents in obese and non-obese children and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin

Sponsor: Children's Mercy Hospital Kansas City

You may qualify if…

  • 8-21 years
  • LDL cholesterol \>130mg/dl (\>95% percentile)
  • SLCO1B1 c.521TT genotype
  • Provide informed permission-assent(\<18 yrs.) or consent (≥18 yrs.)
  • Fasting overnight (\~8 hrs.)
  • Enrolled in Cardiology Pharmacogenomic Repository

You may not qualify if…

  • Pregnancy
  • Non-fasting
  • Non-removable metal in body or MRI unsafe
  • Currently on statin therapy and unwilling to wash out of statin therapy for at least 4 weeks prior to Visit 1 and throughout the duration of the study.
  • Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease.
  • History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\* (absorption, metabolism, distribution, or clearance)
  • Pharmacotherapy that interacts with statins (OATP1B1 inducers/inhibitors) \*
  • Inability to swallow a tablet

Where it's recruiting

Missouri

Kansas City

Source: ClinicalTrials.gov · NCT04903223 · last updated 2026-06-25