NCT04903223RecruitingPhase 1
Liver Adiposity Effects on Pediatric Statin
Effects of Pediatric Liver Adiposity on Statin Disposition and Response
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 May 2021
- Start date
- 1 Apr 2021
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Children's Mercy Hospital Kansas City
- NCT number
- NCT04903223
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 50
- From 1 Apr 2021 to the primary completion date, 30 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Pharmacotherapy that interacts with statins (OATP1B1 inducers/inhibitors) \*
Other illness
- Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease.
Lab values
- History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\* (absorption, metabolism, distribution, or clearance)
- \>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin
Other
- Pregnancy
- Non-fasting
- Non-removable metal in body or MRI unsafe
- Inability to swallow a tablet
- 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.)
Who the study is looking for
- 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
Age in the registry: 8 years to 21 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Mercy Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.