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RecruitingAccepts healthy volunteersPhase 1

Liver Adiposity Effects on Pediatric Statin

Children's Mercy Hospital Kansas City · NCT04903223

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 8–21 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
50
US sites recruiting
1
Study start
April 1, 2021
Record last updated
June 25, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Rosuvastatin 10mg

Conditions: Cholesterol; Lipidosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.)

Recruiting US locations

  • Children's Mercy Hospital

    Kansas City, MO 64108

    Site contact: Jonathan B Wagner, DO · 816-234-3000 · jbwagner@cmh.edu

Study contacts (from the official record)

  • Jonathan Wagner, DO · 816-731-7240 · jbwagner@cmh.edu
  • Jazzie K Holliday · 816-302-3500 · jkholliday@cmh.edu
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