Liver Adiposity Effects on Pediatric Statin

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Children's Mercy Hospital Kansas City
Study ID
NCT04903223
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cholesterol; Lipidosis

Eligibility Criteria

Sex
ALL
Age
8 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • Rosuvastatin 10mg — DRUG
    Rosuvastatin will be administered to all participants on Study Day #2

Study Details

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

Key Dates

Start date
Apr 1, 2021
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Baseline Mevalonate and MRI Imaging
  • Experimental: Mevalonate Change After Rosuvastatin

Primary Outcome Measure

Evaluate effect of Liver Fat Percentage (on MRI) on AUC [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Mercy HospitalKansas CityMissouri64108
Jonathan B Wagner, DO
[email protected]
816-234-3000
Jonathan B Wagner, DO (PRINCIPAL_INVESTIGATOR)

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Children's Mercy Hospital· Kansas City, MO