Dyslipidemia of Obesity Intervention in Teens

Completed · Phase 3 · Has a placebo group

Conditions studied: Dyslipidemia, Obesity

In brief

This trial of pitavastatin will determine efficacy and safety in this high risk population and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.

Key facts

Study ID

NCT02956590

Run by

Carelon Research

People needed

122

Starts

2018-05-01

Expected to finish

2023-06-30

Last updated by the study team

2024-07-05

Who can join

Age: 10 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Boys and girls aged 10 to 19 years (with 2-year availability for study participation)
• BMI ≥85th percentile (using Centers for Disease Control (CDC) BMI charts)
• Fasting lipid profile x2 each with all of the following:
• LDL-C <160 mg/dL and ≥90 mg/dL, and
• TG (triglycerides) <500 mg/dL, and
• TG/HDL-C ratio ≥2.5 or HDL-C <45 mg/dL for boys or HDL-C <50 mg/dL for girls, and
• non-HDL-C ≥120 mg/dL
• Participant consent, or parental/guardian consent and participant assent

You may not qualify if…

• Current use of lipid lowering medication, growth hormone, systemic corticosteroids, cyclosporine, protease inhibitors, erythromycin, rifampin, colchicine, warfarin, second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or antidepressant therapy and antihypertensive medications will be accepted
• Known allergy or hypersensitivity to statin
• Patients who have had bariatric surgery or plan to have bariatric surgery during the trial
• Female who is pregnant, plans to become pregnant or is sexually active without contraception
• Uncontrolled stage 2 hypertension (systolic or diastolic blood pressure ≥95th percentile for age, sex and height percentile + 12 mmHg or ≥140/90, whichever is lower for participants <13 years of age; ≥140/90 for participants ≥13 years of age) confirmed after an appropriate evaluation
• Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose ≥126 mg/dL, HbA1c ≥6.5%, random glucose ≥200 mg/dL, or 2-hour oral glucose tolerance testing glucose ≥200 mg/dL)
• Use of insulin sensitizing therapy
• Known renal insufficiency (known chronic renal disease, estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at screening)
• Uncontrolled thyroid disease (TSH at screening >1.5x upper limit of normal, clinical or other laboratory evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for 6 weeks prior to screening)
• Proteinuria suggestive of renal disease (more than trace together with an elevated urine protein:creatinine ratio as per local lab)
• 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) ≥ 40 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, current alcohol consumption

Where it is running

• Nemours/Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Health System — Washington D.C., District of Columbia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Hospital, University of Utah — Salt Lake City, Utah, United States
• University of Wisconsin — Madison, Wisconsin, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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