A multicenter trial to test pitavastatin calcium in youth with combined dyslipidemia of obesity: Design, implementation, challenges, and responses
- stopped early
Authors' conclusion
The DO IT! Trial was the first to evaluate effects of pitavastatin vs placebo on vascular measures, lipid outcomes and potential adverse effects. Recruitment challenges limited the study sample, but findings may still inform cardiovascular prevention.
Study context
- Population
- Children and adolescents with combined dyslipidemia of obesityconsented
- Participants
- 122 children
- Comparison
- Pitavastatin calcium vs placebo
- Primary endpoint
- Vascular measures of early atherosclerosis, and standard and advanced lipid profiles
- Follow-up
- 2 years
Methodological detailsdesign and implementation report, double-blind, placebo-controlled, multicentre, Barriers: 2-year duration, number of study visits, COVID-19 pandemic effects, Responses: added sites, expanded eligibility, shared educational and promotional materials, bolstered site engagement
- Design and implementation report
- Double-blind
- Placebo-controlled
- Multicentre
- Barriers: 2-year duration, number of study visits, COVID-19 pandemic effects
- Responses: added sites, expanded eligibility, shared educational and promotional materials, bolstered site engagement
Primary result
As reported in the abstract
Recruitment
Consented vs recruitment goal of 177
122
68.9%
Sites
17
Original publication
A multicenter trial to test pitavastatin calcium in youth with combined dyslipidemia of obesity: Design, implementation, challenges, and responses. Am Heart J. Published 15 December 2025. doi:10.
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