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NCT Number: NCT04903223

Liver Adiposity Effects on Pediatric Statin

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

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Key information

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location status: Recruiting

Location contact

Jonathan B Wagner, DO

CONTACT

[email protected]

816-234-3000 ext. 59373

Jonathan B Wagner, DO

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Rosuvastatin 10mg

Drug

Rosuvastatin will be administered to all participants on Study Day #2

Primary outcomes

  1. Evaluate effect of Liver Fat Percentage (on MRI) on AUC

    Time frame: 2 years

    We expect that increased liver adiposity will be associated with higher systemic statin exposure and thus, place those with higher liver adiposity fraction at increased risk for drug toxicity.

  2. Evaluate effect of Liver Fat Percentage (on MRI) on change on plasma mevalonate level

    Time frame: 2 years

    We expect that increased liver adiposity will be associated with an attenuated mevalonate response to a statin in obese children placing those with increased liver adiposity at risk for treatment failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Jazzie K Holliday

CONTACT

[email protected]

816-302-3500

Jonathan Wagner, DO

CONTACT

[email protected]

816-731-7240

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Effects of Pediatric Liver Adiposity on Statin Disposition and Response

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
May 26, 2021
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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