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NCT04903223 · ClinicalTrials.gov registry record · Phase 1

Liver Adiposity Effects on Pediatric Statin

A Phase 1 study of Cholesterol; Lipidosis, sponsored by Children's Mercy Hospital Kansas City.

Recruiting
Registry status
Phase 1
Development phase
50
Enrollment target
1
Study location

NCT04903223: Recruiting Phase 1 study of Cholesterol; Lipidosis, sponsored by Children's Mercy Hospital Kansas City.

NCT04903223 is a Phase 1 study of Cholesterol; Lipidosis that is actively recruiting participants, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04903223, a Phase 1 study of Cholesterol; Lipidosis, is actively recruiting participants, sponsored by Children's Mercy Hospital Kansas City.

RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
1
Study location

Study 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

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Rosuvastatin 10mg

Study Locations (1)

Missouri

  • Children's Mercy Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-04-01
Est. Completion 2026-12-31
Phase Phase 1

What NCT04903223 shows while recruiting

NCT04903223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).

The record links to 1 condition, with Cholesterol; Lipidosis appearing as the primary indexed condition, and to 1 intervention - of which Rosuvastatin 10mg is the first listed.

NCT04903223 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT04903223 about?

NCT04903223 is a clinical study titled "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 ro...

What is the current status of trial NCT04903223?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2021-04-01. Estimated completion is 2026-12-31.

What conditions does trial NCT04903223 study?

This clinical trial studies the following conditions: Cholesterol; Lipidosis.

What interventions are being tested in trial NCT04903223?

The interventions under investigation include: Rosuvastatin 10mg (DRUG).

Who is sponsoring clinical trial NCT04903223?

This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04903223 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04903223's enrollment target sits among peer trials

50 974th of 2000 higher than 984 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04903223, the US trial registry maintained by the National Library of Medicine. NCT04903223 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.