DO IT!

(Pitavastatin Trial)

Study Summary

This condition of obesity with high cholesterol is sometimes called “Combined Dyslipidemia of Obesity” or CDO. When people have CDO for many years, it can cause their arteries to harden and narrow (called atherosclerosis). This can then lead to serious health problems including heart attack, stroke, or even death.

Pitavastatin is commonly known as Livalo and belongs to a group of cholesterol lowering medicines called statins. It is approved by the Food and Drug Administration (FDA) and Health Canada for use in adults and in children with another type of high cholesterol. It lowers blood total cholesterol as well as “bad” cholesterol (called LDL) that raises the risk of heart disease and heart attacks. It also increases the “good” type of cholesterol (called HDL).

For more information, visit ClinicalTrials.gov.


Check back soon for a summary of key study findings!

For more information, visit ClinicalTrials.gov.

Who was in the study?

Male or females between the age of 10 and 19 who have Combined Dyslipidemia of Obesity (CDO).

What happened during the study?

Activities in the study included:

  1. Medical History: We will review your medical chart and collect information about surgeries and medical procedures.
  2. Physical Examination: Weight and height measurements, blood pressure, head circumference and waist circumference.
  3. Blood Draw: Draw a blood sample while fasting to check lab values, take DNA samples and extra blood to be saved for future study.
  4. Pregnancy Test: for female subjects.
  5. Tanner Staging Report: Questionnaire that asks about physical maturity and development.
  6. Three Vascular Measurements: Pulse Wave Velocity, Carotid Intima-Media Thickness and Carotid Stiffness tests will be conducted to see how blood vessels function.

Each participant was in the study for 24 months.

Study Publications

  • A Multicenter Trial to Test Pitavastatin Calcium in Youth with Combined Dyslipidemia of Obesity: Design, Implementation, Challenges, and Responses

    S. D. de Ferranti, American Heart Journal 2026 Apr; 294:107327.

    Obesity can lead to a condition known as combined dyslipidemia of obesity (CDO), where a person has unhealthy levels of fats in their blood, including high triglycerides (TG), low “good” cholesterol (HDL), and high levels of “bad” cholesterol (non-HDL), along with smaller, more harmful particles of LDL cholesterol. This disorder increases the risk of heart disease. While lifestyle changes are the main treatment, they may not be enough, and medications could potentially help, but this has not been well-tested in young people.

    The “Dyslipidemia of Obesity Intervention in Teens (DO IT!) Trial” aimed at testing whether the drug pitavastatin calcium could improve blood vessel health and lipid levels in children and teens with CDO. This was a two-year study where half of the participants took pitavastatin calcium, and the other half took a placebo. The study tracked how well participants’ blood vessels and cholesterol levels responded to the treatment.

    The study faced challenges in recruiting participants, partly due to the study’s long duration, the number of visits required, and the impact of the COVID-19 pandemic. Despite efforts to improve recruitment, the study was stopped early because not enough participants enrolled.

    Although the trial ended early, it was the first of its kind to test the effects of pitavastatin calcium on heart health and cholesterol levels in children with CDO. The results could still offer useful information about preventing heart disease in young people with obesity. Future studies may be more successful if they solicit input from patients and their families early on, shorten the study time, and make visits easier by integrating them with regular healthcare.

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