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RecruitingPhase 1

Liver Adiposity Effects on Pediatric Statin

Effects of Pediatric Liver Adiposity on Statin Disposition and Response

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 21 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how fat in liver cells affects how the liver handles rosuvastatin, a cholesterol-lowering drug, and how well it works. It is for people ages 8–21, with or without obesity, who have high LDL cholesterol and a specific form of the SLCO1B1 gene.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 8–21 years old.
  • Have LDL (bad) cholesterol above 130 mg/dL, above the 95th percentile.
  • Have the SLCO1B1 c.521TT gene type.
  • If under 18, have parent or guardian permission and agree to join. If 18 or older, give consent.
  • Fast overnight—not eat for about 8 hours.
  • Be enrolled in the Cardiology Pharmacogenomic Repository.

Who can't join

  • Be pregnant or have not fasted.
  • Have metal that cannot be removed or another reason an MRI scan is unsafe or cannot be done. Examples include a pacemaker, fear of tight spaces, or body size, such as weighing over 350 pounds.
  • Take a statin and be unwilling to stop it for at least 4 weeks before Visit 1 and throughout the study.
  • Have a heart or blood vessel defect that has not been repaired, or a repaired defect that still causes major blood flow problems.
  • Have a history or test signs of bowel, metabolism, immune system, or kidney disease that could change how the body handles rosuvastatin.
  • Take medicines that interact with statins by affecting OATP1B1, a protein that helps move these drugs.
  • Be unable to swallow a tablet, or have had diarrhea in the past 24 hours.
  • Have liver blood test levels (AST, ALT, total and conjugated bilirubin) more than 5 times the upper normal limit for your age.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.)

Study sites (1)

MO