Recruiting
Phase 1

Pediatric Statin

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT04903223

Conditions

Cholesterol; Lipidosis

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Accepted

Interventions

Rosuvastatin 10mg

Study Details

Brief summary:

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

Conditions

Cholesterol; Lipidosis

Study ID

NCT04903223

Start date

Apr 1, 2021

Status verified date

Nov, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Baseline Mevalonate and MRI Imaging

experimental: Mevalonate Change After Rosuvastatin

Interventions

Rosuvastatin 10mg

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

Primary outcome measure

  • Evaluate effect of Liver Fat Percentage (on MRI) on AUC [ Time Frame: 2 years ]
  • Evaluate effect of Liver Fat Percentage (on MRI) on change on plasma mevalonate level [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Jonathan Wagner, DO

816-731-7240jbwagner@cmh.edu

Jazzie K Holliday

816-302-3500jkholliday@cmh.edu

Locations

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Jonathan B Wagner, DO

816-234-3000jbwagner@cmh.edu

Principal Investigator:

Jonathan B Wagner, DO

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Jun 25, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-06-25.