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Liver Adiposity Effects on Pediatric Statin
RecruitingPhase 1Healthy volunteers welcome
Effects of Pediatric Liver Adiposity on Statin Disposition and Response
Who can join
Ages 8 to 21 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * \>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin * Diarrhea in the last 24 hours * Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)
About the 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
What is being tested
- Rosuvastatin 10mg (drug)
Sponsor: Children's Mercy Hospital Kansas City · Participants: 50 · Started: Apr 1, 2021
Contact the study team
- Jonathan Wagner, DO · Phone: 816-731-7240
- Jazzie K Holliday · Phone: 816-302-3500
Official record on ClinicalTrials.gov — NCT04903223
Locations in the U.S.
| Missouri | Children's Mercy Hospital, Kansas City |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.