Dyslipidemia of Obesity Intervention in Teens

Randomized, double-blind, placebo-controlled clinical trial of pitavastatin for 2 years
comparing the effect of study drug versus placebo on vascular measures in at least 354 obese
(body mass index >95th percentile) adolescents with CDO (defined as high non-HDL-C + high
TG/HDL-C ratio or low HDL-C). Enrollment will take place over 18 months.

Inclusion Criteria:

- Boys and girls aged 10 to 17 years (with 2 year availability for study participation)

- BMI >95th percentile (using CDC BMI charts)

- Fasting lipid profile x2 each with all of the following:

- LDL-C <160 mg/dL, and

- TG <500 mg/dL, and

- TG/HDL-C ratio > 3.0 or HDL-C <45 mg/dL for boys or HDL-C <50 mg/dL for girls,
and

- non-HDL-C >145 mg/dL

- Participant consent, or parental/guardian consent and participant assent

- Participant fluency in English

Exclusion Criteria:

- Current use of lipid lowering medication, antihypertensive medication, growth hormone,
systemic corticosteroids, cyclosporine, protease inhibitors, colchicine, warfarin,
second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or
antidepressant therapy will be accepted

- Female who is pregnant, plans to become pregnant or is sexually active without
contraception

- Stage 2 hypertension (systolic or diastolic blood pressure above the 99th percentile
for age, sex and height percentile + 5 mmHg; confirmed after an appropriate
evaluation)

- Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose
>126 mg/dL, random glucose >200 mg/dL, or 2-hour oral glucose tolerance testing
glucose >200 mg/dL)

- Prediabetes or polycystic ovary syndrome on insulin sensitizing therapy

- Known renal insufficiency

- Uncontrolled thyroid disease

- Proteinuria suggestive of renal disease (urine protein: creatinine >0.2)

- Syndromic patients or patients with neurocognitive delay precluding adherence with
study drug

- Liver disease other than non-alcoholic fatty liver disease (NAFLD) either diagnosed or
suggested by alanine aminotransferase (ALT) ≥ 50 U/L, or severe NAFLD indicated by ALT
≥ 200 U/L

- Unexplained persistent elevated creatine kinase (CK) level >3x upper limit of normal

- Plans to leave the geographic area before completion of the anticipated 2 years of
trial participation

- Any unstable medical or emotional condition or chronic disease that would preclude
following the protocol or impact valid vascular measurement

- Admits to current smoking